Rodilleras y órtesis para tratar la osteoartritis de rodilla
Resumen
Antecedentes
Los individuos con osteoartritis (OA) de la rodilla pueden recibir tratamiento con una rodillera o una órtesis de pie/tobillo. El propósito principal de estas ayudas es reducir el dolor, mejorar la función física y, posiblemente, retrasar la progresión de la enfermedad. Esta es la segunda actualización de la revisión original publicada en el Número 1, 2005, y actualizada por primera vez en 2007.
Objetivos
Evaluar los efectos beneficiosos y los daños de las rodilleras y las órtesis de pie y tobillo en el tratamiento de pacientes con OA de la rodilla.
Métodos de búsqueda
Se hicieron búsquedas en el Registro Cochrane Central de Ensayos Controlados (Cochrane Central Register of Controlled Trials, CENTRAL), MEDLINE y EMBASE (Current Contents, HealthSTAR) hasta marzo 2014. Se examinaron las listas de referencia de los ensayos identificados y los registros de ensayos clínicos de los estudios en curso.
Criterios de selección
Ensayos clínicos aleatorizados y controlados que investigaron todos los tipos de rodilleras y órtesis de pie/tobillo para la OA de la rodilla, en comparación con un control activo o ningún tratamiento.
Obtención y análisis de los datos
Dos autores de la revisión de forma independiente seleccionaron los ensayos y extrajeron los datos. El riesgo de sesgo se evaluó mediante la herramienta Cochrane "Riesgo de sesgo". La calidad de los resultados se analizó mediante una clasificación general de la evidencia por resultado, mediante los criterios GRADE (Grades of Recommendation, Assessment, Development and Evaluation). Como resultado de la heterogeneidad de los estudios, el agrupamiento de los datos de los resultados solo fue posible para tres estudios de plantilla.
Resultados principales
Se incluyeron 13 estudios (n = 1356): cuatro estudios en la primera versión, tres estudios en la primera actualización y seis estudios adicionales (n = 529 participantes) en la segunda actualización. Se incluyeron los estudios que informaron los resultados cuando los participantes con OA de la rodilla temprana a grave (Kellgren & Lawrence grado I‐IV) recibieron tratamiento con una rodillera (rodillera valgus, rodillera neutra o manga de neopreno) o con una órtesis (plantilla con cuña lateral o medial, plantilla neutra, zapato de rigidez variable o constante) o no recibieron tratamiento. Las comparaciones principales incluyeron: 1) rodilleras versus ningún tratamiento; 2) órtesis de pie/tobillo versus ningún tratamiento u otro tratamiento; y 3) rodilleras versus órtesis de pie/tobillo. Siete estudios tuvieron riesgo bajo de sesgo, dos estudios riesgo alto y en cuatro estudios el riesgo de sesgo de selección fue incierto. Cinco estudios tuvieron riesgo bajo, tres estudios tuvieron riesgo alto y en cinco estudios el riesgo de sesgo de detección fue incierto. Diez estudios tuvieron alto riesgo y tres estudios tuvieron bajo riesgo de sesgo de realización. Nueve estudios tuvieron bajo riesgo y cuatro estudios tuvieron alto riesgo de sesgo de informe.
Cuatro estudios compararon el uso de rodilleras con ningún tratamiento, pero solo uno proporcionó datos útiles para el metanálisis a los 12 meses de seguimiento. Un estudio (n = 117, evidencia de calidad baja) mostró falta de evidencia de un efecto en las puntuaciones de dolor de la escala analógica visual (EAV) (cambio porcentual absoluto 0%; diferencia de medias [DM] 0,0; intervalo de confianza [IC] del 95%: ‐0,84 a 0,84), las puntuaciones de la función (cambio porcentual absoluto 1%; DM 1,0; IC del 95%: ‐2,98 a 4,98) y las puntuaciones de la calidad de vida relacionada con la salud (cambio porcentual absoluto 4%; DM ‐0,04; IC del 95%: ‐0,12 a 0,04) después de 12 meses. Muchos participantes interrumpieron su tratamiento inicial debido a la falta de efecto (24 de 60 participantes en el grupo de rodillera y 14 de 57 participantes en el grupo de ningún tratamiento; cambio porcentual absoluto 15%, riesgo relativo [RR] 1,63; IC del 95%: 0,94 a 2,82). Los demás estudios informaron de cierta mejora del dolor, la función y la calidad de vida relacionada con la salud (valor de p ≤ 0,001). En los estudios incluidos no se informó sobre la rigidez y el fracaso del tratamiento (necesidad de cirugía).
Para la comparación de la plantilla con cuña lateral versus ninguna cuña, un estudio (n = 40, evidencia de calidad baja) mostró una puntuación inferior de dolor de la EAV en el grupo de plantilla con cuña lateral (cambio porcentual absoluto 16%; DM ‐1,60; IC del 95%: ‐2,31 a ‐0,89) después de nueve meses. La función, la rigidez, la calidad de vida relacionada con la salud, el fracaso del tratamiento y los efectos adversos no se informaron en el estudio incluido.
Para la comparación de la plantilla con cuñas laterales versus la plantilla neutra después de la combinación de tres estudios (n = 358, evidencia de calidad moderada), se encontró poca evidencia de un efecto en las puntuaciones de dolor de la escala de calificación numérica (ECN) (cambio porcentual absoluto 1,0%; DM 0,1; IC del 95%: ‐0.45 a 0,65), las puntuaciones de rigidez de la Western Ontario‐McMaster Osteoarthritis Scale (WOMAC) (cambio porcentual absoluto 0,1%; DM 0,07; IC del 95%: ‐4,96 a 5,1) y las puntuaciones de la función de la WOMAC (cambio porcentual absoluto 0,9%; DM 0,94; IC del 95%: ‐2,98 a 4,87) después de 12 meses. En un estudio hubo falta de evidencia de un efecto en las puntuaciones de la calidad de vida relacionada con la salud (cambio porcentual absoluto 1,0%; DM 0,01; IC del 95%: ‐0,05 a 0,03; n = 179, evidencia de calidad moderada). El fracaso del tratamiento y los eventos adversos no se estudiaron para esta comparación en los estudios incluidos.
No fue posible agrupar los datos para la comparación de la plantilla con cuñas laterales versus la rodillera valgus. Después de seis meses de seguimiento, no se observaron diferencias estadísticamente significativas en las puntuaciones de dolor de la EAV (cambio porcentual absoluto ‐2,0%; DM ‐0,2; IC del 95%: ‐1,15 a 0,75) y las puntuaciones de la función WOMAC (cambio porcentual absoluto 0,1%; DM 0,1; IC del 95%: ‐7,26 a 0,75) en un estudio (n = 91, evidencia de calidad baja); sin embargo, ambos grupos mostraron mejoría. La rigidez, la calidad de vida relacionada con la salud, el fracaso del tratamiento y los eventos adversos no se informaron en los estudios incluidos para esta comparación.
Conclusiones de los autores
La evidencia no fue concluyente en cuanto a los efectos beneficiosos de la órtesis para el dolor, la rigidez, la función y la calidad de vida en el tratamiento de pacientes con OA de compartimiento medial de la rodilla. Sobre la base de un estudio de una plantilla con cuñas laterales versus ningún tratamiento, se concluye que falta evidencia de un efecto sobre el dolor en pacientes con OA de rodilla varo. Evidencia de calidad moderada muestra la falta de efecto en la mejora del dolor, la rigidez y la función entre los pacientes tratados con una plantilla con cuña lateral y los tratados con una plantilla neutra. Evidencia de calidad baja muestra la falta de efecto en la mejora del dolor, la rigidez y la función entre los pacientes tratados con una rodillera valgus y los tratados con una plantilla con cuña lateral. La elección óptima para una órtesis aún no está clara, y no hay implicaciones a largo plazo.
PICO
Resumen en términos sencillos
Rodilleras y órtesis para la osteoartritis de rodilla
Pregunta de investigación
Este resumen de una revisión Cochrane presenta lo que se conoce de los estudios de investigación sobre los efectos de las rodilleras y las órtesis de pie/tobillo en el tratamiento de pacientes con osteoartritis de la rodilla. Se buscó evidencia hasta marzo 2014. Se encontraron 13 estudios (n = 1356) y se incluyeron en esta actualización seis estudios adicionales (n = 529 participantes).
Características de los estudios
Se incluyeron los estudios que informaron los resultados en pacientes con OA de rodilla temprana a grave (Kellgren y Lawrence grado I‐IV) tratados con una rodillera (rodillera valgus, rodillera neutra, manga de neopreno) o una órtesis (plantilla con cuña lateral o medial, plantilla neutra, zapato de rigidez variable o constante), o que no recibieron tratamiento.
Antecedentes: ¿Qué es la artrosis y qué son las rodilleras y las órtesis?
La osteoartritis es la forma más frecuente de artritis y puede afectar las manos, las caderas, los hombros y las rodillas. En la artrosis, el cartílago que protege los extremos de los huesos se rompe, causando dolor e hinchazón. La osteoartritis puede ocurrir en diferentes áreas de la rodilla o puede afectar a toda la rodilla. Según la zona, la artrosis puede cambiar la alineación de las articulaciones.
Las rodilleras y las órtesis son dispositivos que se utilizan para apoyar la articulación de la rodilla. Las órtesis son plantillas que se ajustan cómodamente dentro de los zapatos. Las rodilleras están hechas de combinaciones de metal, espuma, plástico, material elástico y correas. Una rodillera se puede ajustar especialmente para la persona que la utiliza.
Resultados clave
Esta revisión muestra los siguientes hallazgos en pacientes con osteoartritis de la rodilla.
Uso de una rodillera en comparación con ninguna rodillera:
‐ puede dar lugar a una diferencia escasa o nula en cuanto a la reducción del dolor y la mejora de la función de la rodilla y la calidad de vida después de 12 meses (evidencia de calidad baja); y
‐ hace que muchos pacientes detengan su tratamiento inicial por falta de efecto en ambos grupos.
No se informó sobre la rigidez y el fracaso del tratamiento (necesidad de cirugía).
Uso de una plantilla con una cuña lateral, en comparación con ninguna plantilla:
‐ puede dar lugar a una diferencia escasa o nula en la reducción del dolor (evidencia de calidad baja).
No se informó de la función, la rigidez, la calidad de vida relacionada con la salud, el fracaso del tratamiento y los efectos secundarios.
Uso de una plantilla con una cuña lateral en comparación con una plantilla neutra:
‐ probablemente da lugar a poca o ninguna diferencia en la reducción del dolor y la mejora de la función, la rigidez y la calidad de vida después de 12 meses (evidencia de calidad moderada).
No se informaron los fracasos del tratamiento ni los efectos secundarios.
Uso de una plantilla con una cuña lateral comparada con una rodillera valgus:
‐ puede dar lugar a una diferencia escasa o nula en cuanto a la reducción del dolor y la mejora de la función después de seis meses (evidencia de calidad baja).
No se informó de la rigidez, la calidad de vida relacionada con la salud, el fracaso del tratamiento y los efectos secundarios
A menudo no se cuenta con información precisa acerca de los efectos secundarios y las complicaciones. Los efectos secundarios pueden incluir dolor en la parte posterior de la rodilla, dolor lumbar, dolor en la planta del pie o irritación de la piel.
Calidad de la evidencia
‐ Evidencia de calidad baja indica que los pacientes con OA que utilizan una rodillera pueden tener poca o ninguna reducción del dolor, una mejor función de la rodilla y una mejor calidad de vida.
‐ Evidencia de calidad moderada indica que los pacientes con OA de la rodilla que utilizan plantillas con cuñas laterales o plantillas neutras probablemente tienen poca o ninguna mejora en el dolor, la función y la rigidez.
Authors' conclusions
Summary of findings
| Valgus knee braces and orthoses for varus medial osteoarthritis of the knee | ||||||
| Patient or population: patients with varus medial osteoarthritis of the knee Settings: general hospital Intervention: valgus knee brace or lateral wedge insole Comparison: no brace or neutral insole | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect | Number of participants | Quality of the evidence | Comments | |
| Assumed risk | Corresponding risk | |||||
| Control | Intervention | |||||
| Valgus knee brace compared with no brace | ||||||
| Pain on walking (VAS) Scale from 0 to 10 Follow‐up: 12 months (Higher score is worse) | Mean pain score in control groups was 5.2 | Mean pain in intervention groups was | 115 (1 study) | ⊕⊕⊝⊝ | MD = 0.00 (95% CI ‐0.84 to 0.84) Absolute percent change = 0% (95% CI ‐8.4 to 8.4) Relative percent change = 0% (95% CI ‐1.6 to 1.6) NNTB = not statistically significant | |
| Knee function (HSS) Scale from 0 to 100 (Higher score is better) | Mean function score in control groups was | Mean function in intervention groups was 1.00 higher (2.98 lower to 4.98 higher) | 110 (1 study) | ⊕⊕⊝⊝ | MD = 1.00 (95% CI ‐2.98 to 4.98) Absolute percent change = 1.0% (95% CI 3.0 to 5.0) Relative percent change = 0.01% (95% CI 0.05 to 0.07) NNTB = not statistically significant | |
| Quality of life (EQ‐5D) Scale from 0 to 100 Follow‐up: 12 months (Higher score is better) | Mean health‐related quality of life score in control groups was | Mean health‐related quality of life score in intervention groups was | 117 (1 study) | ⊕⊕⊝⊝ | MD = 0.04 (95% CI ‐0.12 to 0.04) Absolute percent change = 0.04% (95% CI ‐0.12 to 0.04) Relative percent change = 0.07% (95% CI ‐0.2 to 0.07) NNTB = not statistically significant | |
| Total number of adverse events (withdrawals due to lack of effect)c Follow‐up: 12 months | Low‐risk population | RR 1.63 | 117 (1 study) | ⊕⊕⊝⊝ | Absolute percent change = 15% (95% CI ‐1% to 32%) Relative percent change = 63% (95% CI ‐6% to 182%) NNTB = not statistically significant | |
| 246 per 1000 | 400 per 1000 | |||||
| Lateral‐wedge insole compared with neutral insole | ||||||
| Pain on walking (NRS) Scale from 0 to 10 (Higher score is worse) | Mean pain on walking score in control groups was | Mean pain on walking in intervention groups was 0.1 higher (0.45 higher to 0.65 lower) | 224 (2 studies) | ⊕⊕⊕⊝ | MD = 0.10 (95% CI ‐0.45 to 0.65) Absolute percent change = 1.0% (95% CI 4.5 to ‐6.5) Relative percent change = 3.8% (95% CI 1.7 to ‐25.0) NNTB = not statistically significant | |
| Physical function (WOMAC) ‐ Scale from 0 to 100 (Higher score is better) | Mean function score in control groups was | Mean function in intervention groups was | 358 (3 studies) | ⊕⊕⊕⊝ | MD = 0.94 (95% CI ‐2.98 to 4.87) Absolute percent change = 0.9% (95% CI ‐3.0 to 4.9) Relative percent change = 2.6% (95% CI ‐8.1 to 13.3) NNTB = not statistically significant | |
| Health‐related quality of life (HRQoL) Scale from 0 to 1.0 Follow‐up: 12 months (Higher score is better) | Mean health‐related quality of life score in control groups was 0.7 | Mean health‐related quality of life score in intervention groups was 0.01 lower (0.05 lower to 0.03 higher) | 179 (1 study) | ⊕⊕⊕⊝ | MD = 0.00 (95% CI ‐0.06 to 0.06) Absolute percent change = 1.0% (95% CI ‐5.0 to 3.0) Relative percent change = 1.4% (95% CI ‐7.1 to 4.3) NNTB = not statistically significant | |
| *The basis for the assumed risk (e.g. median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADE Working Group grades of evidence. | ||||||
| aLimitations in design and implementation of available studies suggest high likelihood of bias. bImprecision: Results are based on only one study with 117 people. cMany participants stopped their initial treatment because of lack of effect. | ||||||
| Valgus knee brace compared with no brace for varus medial osteoarthritis of the knee | |||||
| Patient or population: patients with varus medial osteoarthritis of the knee | |||||
| Outcomes | Illustrative comparative risks* (95% CI) | Number of participants | Quality of the evidence | Comments | |
| Assumed risk | Corresponding risk | ||||
| No brace | Valgus knee brace | ||||
| Pain (Higher score is worse) | Mean pain score in control groups was | Mean pain on walking in intervention groups was equal (0.84 lower to 0.84 higher) | 115 (1 study) | ⊕⊕⊝⊝ Lowa,b | MD = 0.00 (95% CI ‐0.84 to 0.84) Absolute percent change = 0% Relative percent change = 0% NNTB = not statistically significant |
| Stiffness | See comment | See comment | Not estimablec | See comment | Outcome not reported in included studies |
| Function HSS: scale from 0 to 100 (Higher score is better) | Mean function score in control groups was 69 | Mean function in intervention groups was 1.00 higher (2.98 lower to 4.98 higher) | 110 (1 study) | ⊕⊕⊝⊝ Lowa,b | MD = 1.00 (95% CI ‐2.98 to 4.98) Absolute percent change = 1.0% (95% CI 3.0 to 5.0) Relative percent change = 0.01% (95% CI 0.05 to 0.07) NNTB = not statistically significant |
| Health‐related quality of life EQ‐5S: scale from 0 to 100 Follow‐up: 12 months (Higher score is better) | Mean health‐related quality of life score in control groups was 0.6 | Mean health‐related quality of life score in intervention groups was 0.04 lower (0.12 lower to 0.04 higher) | 117 (1 study) | ⊕⊕⊝⊝ Lowa,b | MD = 0.04 (95% CI ‐0.12 to 0.04) Absolute percent change = 0.04% (95% CI ‐0.12 to 0.04) Relative percent change = 0.07% (95% CI ‐0.2 to 0.07) NNTB = not statistically significant |
| Treatment failure | See comment | See comment | Not estimablec | See comment | Outcome not reported in included studies |
| Serious adverse events | See comment | See comment | Not estimablec | See comment | Outcome not reported in included studies |
| Total number of adverse events (withdrawals due to lack of effect)d | Study population | 117 (1 study) | ⊕⊕⊝⊝ Lowa,b | RR = 1.63 (95% CI 0.94 to 2.82) Absolute percent change = 15% (95% CI ‐1% to 32%) Relative percent change = 63% NNTB = not statistically significant | |
| 400 per 1000 | 246 per 1000 | ||||
| *The basis for the assumed risk (e.g. median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | |||||
| GRADE Working Group grades of evidence. | |||||
| aLimitations in design and implementation of available studies suggest high likelihood of bias. bImprecision: Results are based on only one study with 117 participants. cNo useful data were available. dMany participants stopped their initial treatment because of lack of effect. | |||||
| Lateral wedge insole compared with neutral insole for varus medial osteoarthritis of the knee | |||||
| Patient or population: patients with varus medial osteoarthritis of the knee | |||||
| Outcomes | Illustrative comparative risks* (95% CI) | Number of participants | Quality of the evidence | Comments | |
| Assumed risk | Corresponding risk | ||||
| Neutral insole | Lateral wedge insole | ||||
| Pain (Higher score is worse) | Mean pain on walking score in control groups was 2.6 | Mean pain on walking in intervention groups was 0.1 higher (0.45 higher to 0.65 lower) | 224 | ⊕⊕⊕⊝ | MD = 0.10 (95% CI ‐0.45 to 0.65) Absolute percent change = 1.0% (95% CI 4.5 to ‐6.5) Relative percent change = 3.8% (95% CI 1.7 to ‐25.0) NNTB = not statistically significant |
| Stiffness (Higher score is better) | Mean stiffness score in control groups was 41.6 | Mean stiffness in intervention groups was 0.07 higher (4.96 lower to 5.1 higher) | 358 (3 studies) | ⊕⊕⊕⊝ | MD = 0.07 (95% CI ‐4.96 to 5.10) Absolute percent change = 0.1% (95% CI ‐5.0 to 5.1) Relative percent change = 0.2% (95% CI ‐11.9 to 12.3) NNTB = not statistically significant |
| Function WOMAC: scale from 0 to 100 (Higher score is better) | Mean function score in control groups was 36.6 | Mean function in intervention groups was 0.94 higher (2.98 lower to 4.87 higher) | 358 (3 studies) | ⊕⊕⊕⊝ | MD = 0.94 (95% CI ‐2.98 to 4.87) Absolute percent change = 0.9% (95% CI ‐3.0 to 4.9) Relative percent change = 2.6% (95% CI ‐8.1 to 13.3) NNTB = not statistically significant |
| Health‐related quality of life HRQoL: scale from 0 to 1.0 Follow‐up: 12 months (Higher score is better) | Mean health‐related quality of life score in control groups was 0.7 | Mean health‐related quality of life score in intervention groups was 0.01 lower (0.05 lower to 0.03 higher) | 179 (1 study) | ⊕⊕⊕⊝ | MD = 0.00 (95% CI ‐0.06 to 0.06) Absolute percent change = 1.0% (95% CI ‐5.0 to 3.0) Relative percent change = 1.4% (95% CI ‐7.1 to 4.3) NNTB = not statistically significant |
| Treatment failure | See comment | See comment | Not estimablec | See comment | Outcome not reported in included studies |
| Serious adverse events | See comment | See comment | Not estimablec | See comment | Outcome not reported in included studies |
| Total number of adverse events | See comment | See comment | Not estimablec | See comment | Outcome not reported in included studies |
| *The basis for the assumed risk (e.g. median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | |||||
| GRADE Working Group grades of evidence. | |||||
| aDowngraded for limitations in design and implementation of available studies suggesting high likelihood of bias. bDowngraded for imprecision: Results were based on only one study with 179 participants. cNo useful data were available. | |||||
| Valgus knee brace compared with lateral wedge insole for varus medial osteoarthritis of the knee | |||||
| Patient or population: patients with varus medial osteoarthritis of the knee Settings: general hospital Intervention: valgus knee brace Comparison: lateral wedge insole | |||||
| Outcomes | Illustrative comparative risks* (95% CI) | Number of participants | Quality of the evidence | Comments | |
| Assumed risk | Corresponding risk | ||||
| Lateral wedge insole | Valgus knee brace | ||||
| Pain VAS: scale from 0 to 10 Follow‐up: 6 months (Higher score is worse) | Mean pain score in control groups was 4.8 | Mean pain score in intervention groups was 0.2 lower (1.15 lower to 0.75 higher) | 91 (1 study) | ⊕⊕⊝⊝ Lowa,b | MD = ‐0.20 (95% CI ‐1.15 to 0.75) Absolute percent change = ‐2.0% (95% CI ‐11.5 to 7.5) Relative percent change = ‐4.2% (95% CI ‐24.0 to 15.6) NNTB = not statistically significant |
| Stiffness | See comment | See comment | Not estimable | See comment | Outcome not reported in included studies |
| Function WOMAC: scale from 0 to 100 Follow‐up: 6 months (Higher score is better) | Mean function score in control groups was 50.7 | Mean function score in intervention groups was 0.1 higher (7.26 lower to 0.75 higher) | 91 (1 study) | ⊕⊕⊝⊝ Lowa,b | MD = 0.10 (95% CI ‐7.26 to 7.46) Absolute percent change = 0.1% (95% CI ‐7.26 to 0.75) Relative percent change = 0.2% (95% CI ‐14.3 to 1.5) NNTB = not statistically significant |
| Health‐related quality of life | See comment | See comment | Not estimablec | See comment | Outcome not reported in included studies |
| Treatment failure | See comment | See comment | Not estimablec | See comment | Outcome not reported in included studies |
| Serious adverse events | See comment | See comment | Not estimablec | See comment | Outcome not reported in included studies |
| Total number of adverse events | See comment | See comment | Not estimablec | See comment | Outcome not reported in included studies |
| *The basis for the assumed risk (e.g. median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | |||||
| GRADE Working Group grades of evidence. | |||||
| aDowngraded for imprecision: Results were based on only one study with 91 participants. bDowngraded for limitations in design and implementation of available studies suggesting high likelihood of bias. cNo useful data were available. | |||||
Background
Description of the condition
Osteoarthritis (OA) of the knee is a common medical condition that is often seen in general practice and causes considerable pain and immobility. In the United States, approximately 9% of individuals aged 60 years and older suffer from knee OA (Losina 2013). The prevalence of symptomatic knee OA has increased substantially over the past 20 years. Aging, obesity and increased awareness of knee pain have accounted for this trend (Nguyen 2011). Risks for a poor functional outcome in individuals with knee OA involve collateral and cruciate ligament laxity, age, body mass index (BMI) and degree of pain (Sharma 2003). In addition to consequences for the patient, OA presents a considerable burden for society because of its chronic course, high costs of interventions and related productivity costs (Healy 2002; Hermans 2012).
Osteoarthritis of the entire knee is distinguished from OA of one compartment (Grelsamer 1995), which generally is caused by a mechanical problem (Brouwer GM 2007; Tetsworth 1994). Individuals with OA of the medial compartment often have a varus alignment, and the mechanical axis and load bearing pass through the medial compartment. Those with OA of the lateral compartment generally have a valgus alignment, and the mechanical axis and load bearing pass through the lateral compartment. Malalignment increases risk and progression of knee OA and predicts decline in physical function (Brouwer GM 2007; Sharma 2001; Tanamas 2009).
Initial treatment for patients with OA of the knee is conservative, consisting of restricted activity, decreased body mass index (BMI), patient education and physical therapy (Foley 2003; Fransen 2001; Fransen 2008; Garner 2005; Goorman 2000; Hoffmann 2001; Huang 2000; Hurley 1998; Zhang 2010). Pharmacological treatments tend to only modify symptoms (e.g. analgesics, anti‐inflammatory drugs); however some are intended to be curative (hyaluronic acids, chondroitin sulphate) (Bellamy 2006; Cepeda 2006; Gibofsky 2003; Karlsson 2002; Leopold 2003; Nuesch 2009; Towheed 2006; Uebelhart 2004; Whittle 2011).
Electro‐acupuncture, transcutaneous electrical nerve stimulation (TENS), braces, foot/ankle orthoses and leech therapy are not standard treatments (Rutjes 2009) but can be effective in symptom reduction (Deshaies 2002; Michalsen 2003; Ng 2003). If symptoms persist, surgical therapy such as high tibial osteotomy or knee arthroplasty can be considered (Brouwer RW 2007; Fletcher 2006; Stukenborg 2001) .
Description of the intervention
A knee brace or a foot/ankle orthosis is defined as "any medical device added to a person's body to support, align, position, immobilize, prevent or correct deformity, assist weak muscles, or improve function" (Deshaies 2002). The general purpose of braces and orthoses is to decrease pain, improve physical function and possibly slow disease progression. Proprioception/stability is a hypothesised but unproven underlying explanatory factor. Lateral wedge insoles and special valgus braces are designed to reduce load in the medial compartment (Hewett 1998; Katsuragawa 1999; Kirkley 1999; Komistek 1999; Lindenfeld 1997; Maillefert 2001; Reeves 2011).
Several types of orthoses are available to treat patients with medial knee OA non‐operatively. This review includes studies comparing the laterally wedged insole, the valgus knee brace, the neutral knee brace, the neoprene sleeve and variable shoe stiffness versus each other or versus no treatment. The valgus knee brace and the laterally wedged insole are used most commonly in the non‐operative treatment of varus medial knee OA.
How the intervention might work
The goal of the interventions is to improve function, reduce symptoms and possibly slow disease progression. The valgus knee brace and the laterally wedged insole are used with the goal of unloading the diseased medial compartment by creating a valgus effect on the knee. Neutral braces and neoprene sleeves are thought to immobilise and stabilise the knee. Neutral insoles, shoes of variable stiffness and lateral wedged insoles could have a cushioning effect (Reeves 2011).
Why it is important to do this review
The literature suggests that patients with varus medial knee OA may benefit from braces and foot/ankle orthoses. However many different types of braces and foot/ankle orthoses are available. It remains unclear which brace or foot/ankle orthosis will provide the greatest benefit or harm to patients treated for varus medial knee OA (Parkes 2013; Reeves 2011; Zhang 2010).
Objectives
To assess the benefits and harms of braces and foot/ankle orthoses in the treatment of patients with OA of the knee.
Methods
Criteria for considering studies for this review
Types of studies
Randomised controlled trials (RCTs) and controlled clinical trials investigating all types of braces and foot/ankle orthoses for OA of the knee compared with no treatment or other treatment such as restricted activity, patient education, physiotherapy, pharmacological treatment and orthoses or surgical treatment.
Types of participants
Adult patients (> 18 years) with OA of the knee confirmed by radiological investigation (Kellgren & Lawrence (K&L) grade I‐IV).
Types of interventions
All types of braces (rigid knee braces intended to reduce load, knee sleeves/supporters) and foot/ankle orthoses (laterally or medially wedged insoles with or without an ankle support or variable stiffness shoes) for individuals with OA of the knee. The main comparisons were (1) brace versus no treatment; (2) foot/ankle orthosis versus no treatment or other treatment; and (3) brace versus foot/ankle orthosis.
Types of outcome measures
Major outcomes
We considered major outcomes such as pain, function, stiffness, quality of life, treatment failure (need to undergo surgery), serious adverse events and total number of adverse events.
Minor outcomes
We also considered other outcomes such as radiographic scores, compliance and walking distance.
We considered all major outcomes and presented them in the 'Summary of findings' table.
Search methods for identification of studies
We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and EMBASE (current contents, HealthSTAR) until October 2002 in the original review, until May 2007 in the first update and until March 2014 in the second update to identify clinical trials investigating braces and foot/ankle orthoses for OA of the knee. We performed MEDLINE searches for clinical trials using the strategy of The Cochrane Collaboration (Appendix 1, completed March 2014). We applied no language restriction. Moreover we checked the reference lists of included studies and clinical trial registers for ongoing studies.
Data collection and analysis
Selection of studies
Two review authors initially selected trials on the basis of title and abstract. We assessed title, keywords and abstract to establish whether the study met the inclusion criteria regarding diagnosis, design and intervention. For each selected study, we retrieved the full article for final assessment. Next, two review authors independently performed a final selection of trials to be included in the review, using a pretested standardised form. We resolved disagreements on inclusion by discussion.
Data extraction and management
Three review authors independently extracted data on the intervention, types of outcome measures, follow‐up, loss to follow‐up and outcomes using a standardised form. We have presented the various outcome measures separately. We resolved disagreements or discrepancies on data extraction by discussion.
Assessment of risk of bias in included studies
Two review authors independently assessed risk of bias of included studies. We resolved disagreements in a consensus meeting and when necessary consulted an independent third person. The Cochrane Collaboration recommends a specific tool for assessing risk of bias in each included study. This comprises a description and a judgement for each entry in a 'Risk of bias' table, wherein each entry addresses a specific feature of the study. The judgement for each entry involves providing a response of 'low risk of bias', 'high risk of bias' or 'unclear risk of bias', indicating lack of information or uncertainty about the potential for bias.
Entries used to assess risk of bias include the following (see also 'Risk of bias' table).
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Random sequence generation (selection bias).
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Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence.
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Allocation concealment (selection bias).
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Selection bias (biased allocation to interventions) due to inadequate concealment of allocations before assignment.
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Blinding (performance bias and detection bias).
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Performance bias or detection bias due to knowledge of allocated interventions after assignment.
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Blinding of participants and personnel (performance bias).
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Performance bias due to knowledge of allocated interventions by participants and personnel during the study.
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Blinding of outcome assessment (detection bias).
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Detection bias due to knowledge of allocated interventions by outcome assessors.
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Incomplete outcome data (attrition bias).
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Attrition bias due to quantity, nature or handling of incomplete outcome data.
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Selective reporting (reporting bias).
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Selection of a subset of original variables recorded on the basis of results.
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Measures of treatment effect
For dichotomous outcomes, we calculated risk ratios (RRs) with corresponding 95 per cent confidence intervals (95% CIs). For continuous outcomes, we calculated mean differences (MDs) with 95% CIs.
Unit of analysis issues
Not applicable.
Dealing with missing data
It is unclear to us whether we missed outcome data. Many studies have not published a research protocol. Therefore, we analysed only available data.
Data synthesis
We used RevMan 5 software to analyse the data and have presented the various outcomes in analysis graphs. We used both fixed‐effect and random‐effects models. In cases of substantial between‐trial heterogeneity, we used random‐effects analysis instead of a fixed‐effect approach. Pooling of outcomes was possible only for the comparison of lateral wedged insole versus neutral insole. We considered the rest of the trials to be clinically heterogeneous in terms of study population and intervention.
'Summary of findings' table
We created a 'Summary of findings' table for the major outcomes of pain, function, stiffness, health‐related quality of life, treatment failure, serious adverse events and total adverse events.
We analysed the quality of the presenting results by performing an overall grading of evidence by outcome using the GRADE (Grades of Recommendation, Assessment, Development and Evaluation) approach (Guyatt 2008a; Guyatt 2008b; Schünemann 2008). We assigned the highest quality rating to randomised trial evidence.
The GRADE approach specifies the following levels of quality.
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High quality: Further research is very unlikely to change our confidence in the estimate of effect.
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Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
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Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
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Very low quality: We are very uncertain about the estimate.
Trial evidence can be downgraded to moderate, low or very low quality depending on the presence of the following factors.
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Limitations in design and implementation of available studies suggesting high likelihood of bias.
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Indirectness of evidence (indirect population, intervention, control, outcomes).
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Unexplained heterogeneity or inconsistency of results (including problems with subgroup analyses).
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Imprecision of results (wide confidence intervals).
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High probability of publication bias.
Quality will fall by one level for each factor, up to a maximum of three levels for all factors. If very severe problems are noted for any one factor (e.g. when assessing limitations in design and implementation, all studies were unconcealed and unblinded and lost more than 50% of participants to follow‐up), the quality of randomised trial evidence may fall by two levels on the basis of that factor alone.
If pooling of study results is not possible, then a single study is included and by definition low‐quality evidence, which can be downgraded according to risk of bias items.
Results
Description of studies
Results of the search
The search strategy (Appendix 1, completed May 2014) yielded a total of 217 records from the following databases: Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and EMBASE (current contents, HealthSTAR). The search resulted in identification of the citations of 25 reports of potentially eligible studies, for which (where possible) full reports were obtained. We included a total of 13 studies in the review. We needed the opinion of a third review author once (Shakoor 2008) before we could come to a final decision.
Overall, this review consists of 13 included studies, 12 excluded studies, no ongoing studies and no studies awaiting classification (Figure 1). We checked the reference lists of the included studies but identified no further studies.
Included studies
We included 13 studies described in 17 publications involving 1356 participants; we included four studies in the first version, added three studies in the first update and added six more studies in this second update. We have described these studies in detail in the Characteristics of included studies table.
One group (Maillefert 2001) published separately six‐month and two‐year results, another group presented separately six‐month and one‐year results (Erhart‐Hledik 2012) and another group (Toda 2001) published separately eight‐week, six‐month and two‐year results. We have described the 13 selected studies in detail in the Characteristics of included studies table. Four studies (Brouwer 2006; Kirkley 1999; Müller‐Rath 2011; Sattari 2011) investigated knee braces, and eight studies (Barrios 2009; Bennell 2011; Erhart‐Hledik 2012; Maillefert 2001; Sattari 2011; Toda 2001; Toda 2002; Toda 2008) examined foot/ankle orthoses for medial compartment OA of the knee. Two studies (Raaij van 2010; Sattari 2011) compared a knee brace with a foot orthosis. Only two studies (Brouwer 2006; Rodriques 2008) also assessed the benefits of a brace or a foot/ankle orthosis for treating lateral compartment osteoarthritis. No studies assessed the benefits of a brace or an insole for general OA of the knee. In 12 studies the degree of OA was scored according to Kellgren & Lawrence (K&L) (Kellgren 1957), and in one study (Brouwer 2006) according to Ahlback (Ahlback 1968). In two studies osteoarthritic changes were also checked on magnetic resonance imaging (MRI) (Bennell 2011; Erhart‐Hledik 2012). The mean number of participants in the 13 studies was 103 (range 30‐207). Mean participant age was 62 years (range 48‐65 years). In two trials, all participants were females (Toda 2001; Toda 2002). (See also Characteristics of included studies.)
Barrios 2009 published an RCT of 66 participants with symptomatic medial knee OA (K&L grade II‐IV). In this RCT, a treatment group ‐ a full‐length (9.1 degrees (standard deviation (SD) 3.9 degrees)) laterally wedged insole into the shoe (n = 35) ‐ had been compared with a control group ‐ a non‐custom neutral insole into the shoe (n = 31). Block randomisation was performed based on OA grade, gender and age (older or younger than 55 years). Allocation was done by an administrative assistant who was unaware of the methods used. The study included 29 males and 37 females with medial tibiofemoral OA (scored according to K&L), mean age of 62.4 years and mean BMI of 33.0 kg/m2. Baseline characteristics (gender, BMI, OA grade) did not differ between groups. A total of 20/35 (57%) participants remained in the treatment group and 25/31 (81%) in the control group at final one‐year follow‐up. The primary outcome measure was mean Western Ontario‐McMaster Osteoarthritis Scale (WOMAC) subscore (100‐0); secondary outcomes included a six‐minute walking test and a stair negotiation test. Mean and P values were presented, but SD values were missing.
Bennell 2011 reported a double‐blinded RCT of 200 participants with mild to moderately severe medial knee OA and radiological evidence of osteophytes in the medial compartment or medial joint space narrowing on an x‐ray film. In this RCT, a treatment group ‐ a full‐length five‐degree laterally wedged insole (n = 103) ‐ was compared with a control group ‐ a flat insole (n = 97). The randomisation procedure consisted of a computer‐generated block method using sealed envelopes. Participants included 82 men and 118 women; mean age was 64 years. Mean BMI was 29.2. The degree of radiological OA was scored according to K&L on posteroanterior radiographs and on MRI. Mean varus alignment was 181 degrees. Follow‐up was 12 months. Eleven participants in the intervention group and ten in the control group were lost to follow‐up.
Brouwer 2006 published a multi‐centre RCT of 117 participants with symptomatic unicompartmental knee OA (Ahlback > 0). In this RCT, investigators studied the additive effect of a brace intended to reduce load in the conservative treatment of unicompartmental (medial or lateral) knee OA. A total of 60 participants were included in the intervention group (brace and standard conservative treatment) and 57 in the control group (standard conservative treatment alone). The brace is available for right and left knees in four sizes. The brace consists of a thigh shell and a calf shell (both of carbon fibre) connected by titanium hinges on the medial and lateral sides. The adjustable side bar on the medial side of the brace provides valgus (1‐12.5 degrees) with medial unloading, or varus (1‐10 degrees) with lateral unloading. The randomisation procedure consisted of a computer‐generated block method using sealed envelopes. Participants included 59 men and 58 women. Mean age was 59 years. Mean BMI was 29. The degree of OA was scored according to Ahlback. Patients with an Ahlback score of I or II were included. Mean varus alignment was nine degrees. Mean valgus alignment was six degrees (hip‐knee‐ankle (HKA) angle). Follow‐up was 12 months. Four participants in the control group were lost to follow‐up.
Erhart‐Hledik 2012 reported an RCT of 79 participants with symptomatic medial knee OA and osteoarthritic changes on MRI. In this study a treatment group ‐ variable‐stiffness shoe (n = 40) ‐ was compared with a control group ‐ constant stiffness shoe (n = 39). The randomisation procedure was not described. Participants included 42 men and 37 women. Mean age was 60 years. Mean BMI was 27.7. The degree of radiological OA was scored on MRI at baseline. Follow‐up was 12 months. Eight participants in the intervention group and 13 in the control group were lost to follow‐up.
Kirkley 1999 reported an RCT comparing (1) a valgus brace with medical treatment (n = 41); (2) a neoprene sleeve with medical treatment (n = 36); and (3) a control (i.e. medical treatment only) (n = 33). Individuals with OA of the knee and pain localised to the medial compartment were included in this trial. The valgus brace was custom made and consisted of a polyethylene thigh shell connected to a polyethylene calf shell through a polyaxial hinge on the medial side, which allowed application of four degrees valgus. The randomisation procedure consisted of a computer‐generated block method using sealed envelopes. Follow‐up was six months. Nine participants were lost to follow‐up (neoprene sleeve ‐ two/control ‐ seven). Participants included 79 men and 31 women. Mean age was 59 years. Mean varus alignment was nine degrees. Degree of OA of the knee was described only in the unloader brace group. Outcome data were presented as means and P values but without standard deviations; this made pooling impossible. Additional information was obtained from The Kirkley Research Group, but this information was not sufficient for analysis.
Maillefert 2001 presented an RCT of 156 participants with symptomatic medial knee OA (K&L > I). Laterally wedged insoles (n = 82) were compared with neutral insoles (n = 74). Both insoles were made of Ledos material, which consists of pure rubber with cork powder. The laterally elevated insoles were individually modelled, with elevation depending on static pedometer evaluation. The randomisation procedure was not described. Participants included 41 men and 108 women. Mean age was 65 years. Mean BMI was 29. Degree of varus alignment was not measured. After six months' follow‐up, nine participants (four from the wedged insole group) were lost to follow‐up. Two‐year follow‐up results were provided in 2004 (Pham 2004). A total of 106 participants completed the two‐year follow‐up: neutrally wedged insole (n = 51) versus laterally wedged insole (n = 55).
Müller‐Rath 2011 reported a non‐blinded RCT of 33 participants with symptomatic medial knee OA with a minimum of grade II according to the radiographic classification of K&L. Two treatment groups were included: a valgus knee brace (n = 13) and an elastic knee bandage (n = 10). The control group consisted of untreated individuals (n = 10). The randomisation procedure was not described. Participants included 24 men and nine women; mean age was 53.2 years. Mean BMI was 27.2. Mean alignment was 189 degrees of varus femoro‐tibial angle (FTA). The number of participants lost to follow‐up was not reported.
Raaij van 2010 reported a non‐blinded RCT of 91 participants with symptomatic medial knee OA (K&L ≥ I). Participants were block‐randomised to treatment with a 10‐mm laterally full‐length wedged insole (index group, n = 45) or a valgus brace (control group, n = 46). Baseline characteristics were similar regarding mean age (55 years), mean BMI (29 kg/m2), medial and lateral OA grades, analgesic use, mean VAS pain score (5.6 (0‐10 scale)) and mean WOMAC function (47 (0‐100 scale)). Gender differed statistically significantly (index group 65% female vs control group 35% female). At six months, a non‐blinded investigator assessed VAS and WOMAC scores as well as varus alignment correction in the frontal plane using the HKA angle on standardised whole leg films.
Rodriques 2008 randomly assigned 30 consecutive women with bilateral valgus deformity knee OA to two groups: medial insole (insoles with 8‐mm medial elevation at the rearfoot (n = 16)) and neutral insoles (similar insoles without elevation (n = 14)). Both groups also wore ankle supports. The demographic features of both groups were similar regarding mean age (62 years), mean BMI (30 kg/m2), mean disease duration (five years), radiographic osteoarthritis severity (K&L), race distribution and sedentary habits. A blinded examiner assessed VAS, Lequesne and WOMAC scores, along with femorotibial, talocalcaneal and talar tilt angles at baseline and after eight weeks.
Sattari 2011 reported an RCT of 60 participants with knee pain, genu varum and moderate to severe medial knee OA (K&L grade III or IV). Investigators included two treatment groups: a custom‐molded valgus stress knee support (n = 20) and a 1/4‐inch laterally wedged insole (n = 20). The control group (n = 20) received only general management that was universally applied to all three groups, consisting of activity modification, heating agents, straight leg raising, isometric quadriceps home exercises and analgesic use, when needed. The randomisation procedure was computer‐generated. Participants included 22 men and 38 women. Mean age was 48 years. Mean VAS pain score was 6.9. The degree of radiological OA was scored according to K&L. Follow‐up was nine months. Five participants were lost to follow‐up.
Toda 2001 published a prospective trial comparing an elastic subtalar strapped insole (n = 46) versus a traditional lateral wedge insole (n = 44). This study included individuals with symptomatic medial knee OA (K&L II‐IV). The wedge of the strapped insole was made from urethane with elevation of 6.35 mm strapped to an ankle sprain supporter. The traditional insole was a lateral rubber heel wedge with elevation of 6.35 mm. Quasi‐randomisation was performed according to birth date. All participants were female. Mean age was 65 and mean BMI was 25. Follow‐up was eight weeks, and no participant was lost to follow‐up. Standing radiographs of participants with and without their respective insoles were taken before entry into the eight‐week study. Degree of varus was 181 degrees FTA. Six‐month results were published in 2004. A total of 61 participants completed the six‐month follow‐up: subtalar strapped insole (n = 29) versus traditional laterally wedged insole (n = 32). Two‐year results were published in 2006. Only 42 participants completed the two‐year follow‐up: subtalar strapped insole (n = 21) versus traditional laterally wedged insole (n = 21). Analysis was performed without an intention‐to‐treat approach. All results were presented in the original articles as pre/post analysis, not as between‐group differences (Toda 2001). However, for both the original review and the updated review, the study author was contacted for more information; he sent the missing information on between‐group analysis of FTA, VAS and Lequesne index scores.
Toda 2002 published a second trial comparing a subtalar strapped insole (n = 42) with a sock‐type ankle supporter (n = 46). Individuals with symptomatic medial knee OA were included in this trial (K&L II‐IV). The wedge of the strapped insole was made from urethane with elevation of 6.35 mm strapped to an ankle sprain supporter. The sock‐type ankle support extended from malleoli to metatarsals and consisted of a lateral wedged heel insole with elevation of 6.35 mm. The trial took place in the same year (2000) as the first study. The quasi‐randomisation procedure was performed according to birth date. All participants were female. Mean age was 65 and mean BMI was 25. Degree of varus was 181 degrees (FTA). Follow‐up was eight weeks, and no participant was lost to follow‐up. Results were presented as pre/post analysis, not as between‐group differences. Second, the Lequesne index was presented graphically and no exact numbers were given. However, the study author was contacted for more information again, and he provided the missing information on between‐group analysis of the Lequesne index.
Toda 2008 published a third RCT of 227 participants with symptomatic medial knee OA (K&L I‐IV). In this study a placebo ‐ a neutral wedged insole into shoes (n = 45) ‐ was compared with four interventions ‐ a wedged insole with shoes (n = 45), a sock‐type ankle supporter with a wedged insole without shoes (n = 46), a subtalar strapped insole with shoes (n = 45) and a subtalar strapped insole without shoes (n = 46). The randomisation procedure consisted of a computer‐generated block method using sealed envelopes. Baseline characteristics and outcomes were presented only for the 207 participants who completed the 12‐week follow‐up. A total of 20 of 227 participants did not complete the study, which included 24 men and 183 women. Mean age was 65 years. Mean BMI was 25. Degree of OA was scored according to K&L. Degree of varus was 181 degrees (FTA). Most results were presented as pre/post analysis, and only intake of non‐steroidal anti‐inflammatory drugs (NSAIDs) was compared between placebo and different interventions.
Outcome measures included function scores, VAS scores (pain), analgesic/NSAID intake, walking distance, WOMAC scores (pain, function and stiffness), Hospital for Special Surgery knee scores (HSS; function), McMaster Toronto Arthritis score (MACTAR; function), Lequesne index (pain and function), degree of OA (Ahlback and K&L), global patient assessment, quality of life (EQ‐5D; a measure of health status), leg alignment (HKA angle; FTA), compliance and side effects.
Excluded studies
After retrieving the full text for final assessment, the review authors excluded 12 studies (Baker 2007; Birmingham 2001; Horlick 1993; Hunter 2012; Katsuragawa 1999; Kuroyanagi 2007; Matsuno 1997; Rooser 1988; Sasaki 1987; Shakoor 2008; Toda 2002b; Tohyama 1991): two studies (Sasaki 1987; Tohyama 1991) because of a retrospective design, four studies because of a cross‐over design (Baker 2007; Hunter 2012; Kuroyanagi 2007; Shakoor 2008), four studies because of lack of a control group (Birmingham 2001; Horlick 1993; Katsuragawa 1999; Matsuno 1997) and two studies (Rooser 1988; Toda 2002b) because investigators did not report the targeted outcome measure.
Risk of bias in included studies
Further details on risk of bias of each study are available in Figure 2, Figure 3 and the 'Risk of bias' tables (Characteristics of included studies).
Figure 2 Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
Allocation
Randomisation was performed in all studies. However in four studies, the procedure was not clearly described (Maillefert 2001; Müller‐Rath 2011; Rodriques 2008; Sattari 2011). In the other nine studies, the randomised sequence was adequately generated and clearly described (Barrios 2009; Bennell 2011; Brouwer 2006; Erhart‐Hledik 2012; Kirkley 1999; Raaij van 2010; Toda 2001; Toda 2002; Toda 2008). In seven studies, randomisation and concealment of allocations before assignment were adequately generated (Barrios 2009; Bennell 2011; Brouwer 2006; Erhart‐Hledik 2012; Kirkley 1999; Raaij van 2010; Toda 2008).
Blinding
In many studies, blinding procedures for treatment providers, participants and outcome assessors were insufficient. In most trials, blinding procedures for outcome assessors, treatment providers and participants were scored as 'high risk'. In five studies at least one of the outcome assessors was blinded (Bennell 2011; Erhart‐Hledik 2012; Rodriques 2008; Toda 2002; Toda 2008), and in only three of these studies, care providers and participants were also blinded (Bennell 2011; Erhart‐Hledik 2012; Rodriques 2008).
Incomplete outcome data
In six studies, incomplete outcome data were not adequately addressed. These studies with drop‐outs did not include an intention‐to‐treat analysis (Kirkley 1999; Müller‐Rath 2011; Sattari 2011; Toda 2001; Toda 2002; Toda 2008).
Selective reporting
In most studies, the selective outcome reporting item was unclear because no study protocol was provided (Kirkley 1999; Müller‐Rath 2011; Sattari 2011; Toda 2001; Toda 2002; Toda 2008).
Effects of interventions
See: Summary of findings for the main comparison Braces and orthoses for varus medial osteoarthritis of the knee; Summary of findings 2 Valgus knee brace compared with no brace for varus medial osteoarthritis of the knee; Summary of findings 3 Lateral wedge insole compared with neutral insole for varus medial osteoarthritis of the knee; Summary of findings 4 Valgus knee brace compared with lateral wedge insole for varus medial osteoarthritis of the knee
We have described comparisons of three main groups, namely, knee brace, foot/ankle orthosis and knee brace versus laterally wedged insole. Below we present the effects of interventions for the main comparisons, and we present the quality of evidence scored by the GRADE approach for each outcome. A 'Summary of findings' table was created using GRADEpro (http://ims.cochrane.org/revman/gradepro) for the three main comparisons, namely, valgus knee brace versus no brace (see summary of findings Table for the main comparison; summary of findings Table 2), laterally wedged insole versus neutral insole (see summary of findings Table for the main comparison; summary of findings Table 3) and valgus knee brace versus laterally wedged insole (see summary of findings Table 4). We have included in our 'Summary of findings' tables the outcomes of pain, stiffness, physical functioning, health‐related quality of life, treatment failure, serious adverse events and total adverse events. Pooling of outcomes was possible only for the comparison of laterally wedged insole versus neutral insole. Data on other comparisons could not be pooled. Almost all studies used different interventions and comparison treatments with a wide variety of outcome measures, often with different follow‐up times.
Valgus knee brace versus no treatment
Four studies described the results of knee braces versus no treatment in OA of the knee (Brouwer 2006; Kirkley 1999; Müller‐Rath 2011; Sattari 2011).
Pain scores
We found four studies that reported pain scores. Brouwer 2006 reported improved VAS pain score after 12 months' follow‐up; however no statistically significant difference was found with no treatment (MD 0, 95% CI ‐0.8 to 0.8). Kirkley 1999 reported significantly better WOMAC pain scores in the brace group compared with the no brace group (P value < 0.001) after six months. Müller‐Rath 2011 reported statistically significantly improved VAS score in a valgus knee brace group after 16 weeks but no improvement in the control group (no treatment). Müller‐Rath 2011 provided no between‐group comparison. In Sattari 2011 the severity of pain decreased statistically significantly more in the knee brace group compared with the no treatment group (MD ‐2.8, 95% CI ‐3.6 to ‐2.0) after nine months (see also Analysis 1.1).
Function
We found three studies that reported function scores. Brouwer 2006 reported statistically non‐significant results or lack of evidence of effect of HSS knee function for patients with a valgus knee brace and no brace after 12 months of follow‐up (MD 1.0, 95% CI ‐3.0 to 5.0). Kirkley 1999 found after six months' follow‐up better WOMAC physical function scores in the brace group than in the no brace group (P value ≤ 0.001). Müller‐Rath 2011 reported improved Tegner, Insal, Lequesne and WOMAC scores in a valgus knee brace group but no improvement in the control group (no treatment). Müller‐Rath 2011 provided no between‐group comparisons (see also Analysis 1.2).
Stiffness
Stiffness was not reported in the included studies.
Health‐related quality of life
We found two studies that reported health‐related quality of life. Brouwer 2006 found no statistically significant differences in EuroQol score after 12 months between participants with and without a knee brace (MD ‐0.04, 95% CI ‐0.12 to 0.04). Kirkley 1999 found after six months' follow‐up statistically significant improvement in disease‐specific quality of life (P value 0.001) in favour of the brace group (see also Analysis 1.4).
Treatment failure
Treatment failure was not reported in the included studies.
Serious adverse events
Serious adverse events were not reported in the included studies.
Total adverse events
In total, 24 of 60 participants in the brace group and 14 of 57 participants in the control group in Brouwer 2006 stopped their initial treatment, most often because of lack of effect (RR 1.63, 95% CI 0.94 to 2.82) (see also Analysis 1.5). Other reasons for stopping were skin irritation (n = 2) and poor fit (n= 2). Sattari 2011 and Müller‐Rath 2011 reported no side effects in either group.
Radiographic scores
Radiographic scores were not reported in the included studies.
Compliance
Compliance was not reported in the included studies.
Walking distance
We found two studies that reported walking distance. Brouwer 2006 reported no statistically significant difference in walking distance after 12 months in a brace group compared with a no brace group (MD 0.4, 95% CI ‐0.9 to 1.7). Sattari 2011 reported statistically significantly increased walking distance in the brace group after nine months in contrast to the control group, which received no treatment (MD 1.2, 95% CI 1.0 to 1.5) (see also Analysis 1.3).
According to the GRADE approach
Low‐quality inconclusive evidence suggests that patients with varus medial knee OA benefit more from brace treatment than from no treatment for the outcomes of pain, function and health‐related quality of life (Guyatt 2008a; Guyatt 2008b; Schünemann 2008).
Foot/Ankle orthosis
Four studies (Barrios 2009; Bennell 2011; Maillefert 2001; Sattari 2011) described the results of a foot/ankle orthosis for medial compartment OA of the knee (foot/ankle orthosis vs no treatment or a neutral insole) (see also summary of findings Table 3).
Laterally wedged insole versus no treatment
One study (Sattari 2011) described the effects of a laterally wedged insole versus no treatment.
Pain scores
In Sattari 2011, a statistically significantly decreased pain score is described in the insole group compared with the no treatment group (MD ‐1.6, 95% CI ‐2.3 to ‐0.9) (see also Analysis 3.1).
Function
Function was not reported in the included study.
Stiffness
Stiffness was not reported in the included study.
Health‐related quality of life
Health‐related quality of life was not reported in the included study.
Treatment failure
Treatment failure was not reported in the included study.
Serious adverse events
Serious adverse events were not reported in the included study.
Total adverse events
Adverse events were not reported in the included study.
Radiographic scores
Radiographic scores were not reported in the included study.
Compliance
Compliance was not reported in the included study.
Walking distance
Sattari 2011 described no statistically significant differences in walking distance after nine months between laterally wedged insole versus no treatment (MD 0.7, 95% CI 0.5 to 0.9) (see also Analysis 3.2).
Laterally wedged insole versus neutral insole
Three studies (Barrios 2009;Bennell 2011;Maillefert 2001) described the effects of a laterally wedged insole versus a neutral insole.
Pain scores
In Barrios 2009, the WOMAC pain subscale improved statistically significantly in both study groups (neutral insole and laterally wedged insole) compared with baseline at one‐year follow‐up. Between‐group comparisons showed no statistically significant differences (MD ‐2.5, 95% CI ‐13.5 to 8.5). Bennell 2011 showed small mean reductions in pain scores over time in a neutral insole group and in a laterally wedged insole group; however these reductions were smaller than the minimal clinically important difference. Between‐group comparisons did not show a statistically significant difference (MD 1.0, 95% CI ‐3.8 to 5.8). At six months' follow‐up, Maillefert 2001 described a statistically significantly increased WOMAC pain score in a neutral group compared with a laterally wedged insole group (MD 6.4, 95% CI 0.0 to 12.9) (see also Analysis 4.1 and Analysis 4.2).
Function
We found three studies that reported function. In Barrios 2009, the WOMAC function subscale score improved statistically significantly in both study groups (neutral insole and laterally wedged insole) compared with baseline at one‐year follow‐up. Between‐group comparisons showed no statistically significant differences (MD 1.4, 95% CI ‐9.2 to 12.0). Bennell 2011 showed in both neutral insole and laterally wedged insole groups small mean reductions in WOMAC function scores over time; however these reductions were smaller than the minimal clinically important difference. Between‐group comparisons did not show a statistically significant difference (MD 1.0, 95% CI ‐4.1 to 6.1). Maillefert 2001 described a non‐statistically significant difference in WOMAC function score after six months in a laterally wedged insole group compared with a neutral insole group (MD 0.6, 95% CI ‐6.9 to 8.1) (see also Analysis 4.4).
Stiffness
We found three studies that reported stiffness. In Barrios 2009, the WOMAC stiffness subscale score improved statistically significantly in both study groups (neutral insole and laterally wedged insole) compared with baseline at one‐year follow‐up. Between‐group comparisons showed no statistically significant differences (MD 4.1, 95% CI ‐10.1 to 18.3). Bennell 2011 showed in both neutral insole and laterally wedged insole groups small mean reductions in WOMAC stiffness scores over time; however these reductions were smaller than the minimal clinically important difference. Between‐group comparisons did not show a statistically significant difference (MD 0.0, 95% CI ‐7.3 to 7.3). Maillefert 2001 found at six months' follow‐up no statistically significant difference in WOMAC stiffness in a neutral compared with a wedged insole group (MD ‐1.1, 95% CI ‐9.0 to 6.8) (see also Analysis 4.3).
Health‐related quality of life
Health‐related quality of life was not reported in the included studies.
Treatment failure
During 12‐month follow‐up, 43% of participants in the lateral wedge group versus 19% of those in the neutral insole group changed their initial treatment in Barrios 2009. Mean duration of insole use in Bennell 2011 was statistically significantly less in the laterally wedged insole group than in the neutral insole group.
Serious adverse events
Serious adverse events were not reported in the included studies.
Total adverse events
Adverse events were not reported in the included studies.
Radiographic scores
Radiographic scores were not reported in the included studies.
Compliance
Maillefert 2001 found statistically significantly better compliance with the laterally wedged insole (87.8%) than with the neutral insole (74.3%).
Walking distance
Walking distance was not reported in the included studies.
According to the GRADE approach
Evidence is lacking to suggest that a laterally wedged insole is more effective than no treatment. Moderate evidence suggests that a laterally wedged insole is as effective as a neutral insole for the outcomes of pain, function and stiffness (Guyatt 2008a; Guyatt 2008b; Schünemann 2008).
Knee brace versus laterally wedged insole
Two studies (Raaij van 2010; Sattari 2011) described the results when a valgus knee brace versus a laterally wedged insole was used for medial compartment OA of the knee (see also summary of findings Table 4).
Pain scores
We found two studies that reported pain scores. In Raaij van 2010 after six months' follow‐up, VAS pain scores statistically significantly improved in both the insole group and the brace group compared with baseline measurements, but no statistically significant differences were observed between the two study groups for this outcome (MD 0.2, 95% CI ‐1.15 to 0.75). In Sattari 2011, severity of pain decreased statistically significantly in the knee brace group and in the laterally wedged insole group. Investigators reported less pain in the brace group (MD ‐2.8, 95% CI ‐3.6 to ‐2.0) after nine months (see also Analysis 2.3).
Function
We found one study that reported function scores. Raaij van 2010 reported statistically significantly improved WOMAC function scores in both the insole group and the brace group compared with baseline measurements but noted no statistically significant differences between the two study groups for this outcome (MD 0.1, 95% CI ‐7.26 to 0.75) (see also Analysis 2.2).
Stiffness
None of the studies reported a specific stiffness score.
Health‐related quality of life
Health‐related quality of life was not reported in the included studies.
Treatment failure
Treatment failure was not reported in the included studies.
Serious adverse events
Serious adverse events were not reported in the included studies.
Total adverse events
Adverse events were not reported in the included studies.
Radiographic scores
Radiographic scores were not reported in the included studies.
Compliance
Compliance was not reported in the included studies.
Walking distance
We found one study that reported walking distance. Sattari 2011 reported an MD of 0.5 km (95% CI 0.23 to 0.77) in favour of the brace group (see also Analysis 2.1).
According to the GRADE approach
Low‐quality evidence suggests no statistically significant differences in clinical effect between the laterally wedged insole group and the valgus knee brace group for the outcomes of pain and function (Guyatt 2008a; Guyatt 2008b; Schünemann 2008).
Discussion
Summary of main results
We conducted this review to assess the benefits and harms of braces and orthoses for treatment of patients with osteoarthritis (OA) of the knee. We included a total of 13 studies (n = 1356). These studies have reported results for patients with early to severe knee OA (Kellgren & Lawrence (K&L) I‐IV) treated with a valgus knee brace, a laterally wedged insole, a neutral insole or a variable or constant stiffness shoe, or given no treatment.
We found inconclusive evidence for the benefits of a valgus knee brace: Only four controlled trials were published. Kirkley 1999 concluded that in patients with varus knee OA, a brace provides additional beneficial effects in terms of pain and function compared with medical treatment alone. However, baseline characteristics were different between study groups, and the quality of the study was low. Brouwer 2006 concluded that a brace offers little or no additional effect compared with conservative treatment alone in patients with unicompartmental OA. However, many patients do not adhere in the long run to this kind of treatment because the positive effects are too small or because the side effects are too large. Müller‐Rath 2011 reported improved Tegner, Insal, Lequesne, Western Ontario‐McMaster Osteoarthritis Scale (WOMAC) and visual analogue scale (VAS) scores in the knee brace group after 16 weeks of treatment. They reported no improvement in the control group (no treatment) and described no side effects of treatment; however this study was sponsored, and study authors were not able to provide their data because of a server breakdown. Sattari 2011 reported a statistically significantly decreased pain score in the knee brace group compared with the no treatment group after nine months. Walking distance was increased statistically significantly in the brace group in contrast to the no treatment group after nine months. Investigators described no side effects of the brace. All four studies showed some clinical effect; however the methodological quality of these studies was low.
Moderate‐quality evidence shows the benefits of a laterally wedged insole (vs no treatment or a neutral insole) for medial compartment OA: We included seven controlled trials in this review with conflicting evidence. Barrios 2009, Maillefert 2001, Sattari 2011, Toda 2002 and Toda 2008 reported statistically significantly improved patient‐reported outcomes after a laterally wedged insole was worn; however Bennell 2011 and Toda 2001 reported reductions smaller than the minimal clinically important difference.
Conflicting evidence was found for preference of a neutral or a laterally wedged insole. Results reported by Barrios 2009 favoured the laterally wedged insole, Maillefert 2001 favoured the neutral insole and Bennell 2011 reported no statistically significant differences between the two insoles. Pooling of results of three studies comparing laterally wedged and neutral insoles resulted in lack of evidence of an effect on WOMAC pain scores, WOMAC stiffness scores and WOMAC function scores at one month and at 12 months (see also summary of findings Table 3).
Data for the comparison of laterally wedged insole versus valgus knee brace could not be pooled. After six months' follow‐up, VAS pain scores and WOMAC function scores were improved and did not differ statistically significantly in the two groups (see also summary of findings Table 4).
Overall completeness and applicability of evidence
Four trials investigated a knee brace and eight studies examined foot/ankle orthoses for medial compartment OA of the knee. It is important to note that the findings of these studies may lack generalisability: In the studies of Toda and Rodriques (Toda 2001; Toda 2002; Rodriques 2008), all participants were female, and in Kirkley 1999 and Sattari 2011, most participants were male. In all studies the age of participants was relatively high (mean 63 years). In the Kirkley 1999 trial, baseline characteristics differed between participants. It is important to present full data: Kirkley 1999 presented change scores without baseline scores and without a standard deviation. Toda 2001 and Toda 2002 presented pre‐analysis and post‐analysis results but did not report between‐group differences. Müller‐Rath 2011 presented their scores only graphically and could not provide their data because of a server breakdown.
Particularly, researchers studied the effects of braces and orthoses for medial compartment OA. Compared with lateral compartment OA of the knee, medial compartment OA has a much higher prevalence because lateral compartment OA is associated with trauma and is less clinically frequent. This is probably why only one randomised controlled trial (RCT) (Brouwer 2006) examined the effect of a brace or an orthosis for lateral compartment or general OA of the knee. Furthermore, varus bracing for lateral OA is probably less effective; the adduction moment at the knee during the stance phase of walking causes mainly medial loading (Johnson 1980). In general OA of the knee, there is no compartment to unload, and perhaps a sleeve or a neutral brace will benefit. No studies compared a brace or an orthosis with operative treatment such as high tibial osteotomy or unicompartmental knee arthroplasty.
Quality of the evidence
Two studies in this review had low risk of any type of bias, six studies had moderate risk and five studies had high risk. The randomisation procedure frequently was not described or was insufficient. Except for the trials of Bennell 2011, Brouwer 2006, Kirkley 1999, Raaij van 2010 and Toda 2008, the randomisation procedure was not described or was inadequate. In most studies, blinding procedures were insufficient, although we realise that when braces are used, blinding is not always possible; for footwear inserts, it is generally less difficult. Results were based on small studies, leading to imprecision.
Potential biases in the review process
One study did not report the number of participants lost to follow‐up. This study was funded by Medi, provider of orthoses. Outcomes were presented only graphically in this publication. Study authors were not able to provide their data on request because of a "server breakdown" (Müller‐Rath 2011).
Agreements and disagreements with other studies or reviews
Other meta‐analyses or systematic reviews were not available for comparison of our results.
Figure 2 Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
Comparison 1 Brace versus no treatment, Outcome 1 Pain (VAS).
Comparison 1 Brace versus no treatment, Outcome 2 Knee function (HSS).
Comparison 1 Brace versus no treatment, Outcome 3 Walking distance (km).
Comparison 1 Brace versus no treatment, Outcome 4 Quality of life (EQ‐5D).
Comparison 1 Brace versus no treatment, Outcome 5 Total adverse events.
Comparison 2 Brace versus lateral wedge insole, Outcome 1 Walking distance.
Comparison 2 Brace versus lateral wedge insole, Outcome 2 WOMAC 6 months.
Comparison 2 Brace versus lateral wedge insole, Outcome 3 Pain (VAS).
Comparison 3 Lateral wedge insole versus no insole, Outcome 1 Pain (VAS).
Comparison 3 Lateral wedge insole versus no insole, Outcome 2 Walking distance (km).
Comparison 4 Lateral wedge insole versus neutral insole, Outcome 1 Pain (NRS).
Comparison 4 Lateral wedge insole versus neutral insole, Outcome 2 Pain (WOMAC).
Comparison 4 Lateral wedge insole versus neutral insole, Outcome 3 Stiffness (WOMAC).
Comparison 4 Lateral wedge insole versus neutral insole, Outcome 4 Physical function (WOMAC).
Comparison 4 Lateral wedge insole versus neutral insole, Outcome 5 Health‐related quality of life.
Comparison 4 Lateral wedge insole versus neutral insole, Outcome 6 Physical activity scale for the elderly.
Comparison 4 Lateral wedge insole versus neutral insole, Outcome 7 Number of steps taken per day.
Comparison 4 Lateral wedge insole versus neutral insole, Outcome 8 Global patient assessment at 24 months.
Comparison 4 Lateral wedge insole versus neutral insole, Outcome 9 Compliance at 6 months.
Comparison 4 Lateral wedge insole versus neutral insole, Outcome 10 Time for negotiation of stairs.
Comparison 4 Lateral wedge insole versus neutral insole, Outcome 11 6‐Minute walk distance.
Comparison 5 Subtalar strapped insole versus inserted lateral wedge insole, Outcome 1 Pain (VAS).
Comparison 5 Subtalar strapped insole versus inserted lateral wedge insole, Outcome 2 Lequesne index.
Comparison 5 Subtalar strapped insole versus inserted lateral wedge insole, Outcome 3 FTA ‐ angle.
Comparison 5 Subtalar strapped insole versus inserted lateral wedge insole, Outcome 4 Side effects at 8 weeks.
Comparison 6 Subtalar strapped insole versus sock‐type insole, Outcome 1 FTA angle.
Comparison 6 Subtalar strapped insole versus sock‐type insole, Outcome 2 Aggregate score.
Comparison 7 Medial wedge insole versus neutral insole, Outcome 1 VAS rest.
Comparison 7 Medial wedge insole versus neutral insole, Outcome 2 VAS movement.
Comparison 7 Medial wedge insole versus neutral insole, Outcome 3 VAS night.
Comparison 7 Medial wedge insole versus neutral insole, Outcome 4 WOMAC.
Comparison 7 Medial wedge insole versus neutral insole, Outcome 5 Lequesne.
Comparison 8 Variable stiffness shoe versus constant stiffness shoe, Outcome 1 Pain (WOMAC).
Comparison 8 Variable stiffness shoe versus constant stiffness shoe, Outcome 2 Stiffness (WOMAC).
Comparison 8 Variable stiffness shoe versus constant stiffness shoe, Outcome 3 Physical function (WOMAC).
| Valgus knee braces and orthoses for varus medial osteoarthritis of the knee | ||||||
| Patient or population: patients with varus medial osteoarthritis of the knee Settings: general hospital Intervention: valgus knee brace or lateral wedge insole Comparison: no brace or neutral insole | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect | Number of participants | Quality of the evidence | Comments | |
| Assumed risk | Corresponding risk | |||||
| Control | Intervention | |||||
| Valgus knee brace compared with no brace | ||||||
| Pain on walking (VAS) Scale from 0 to 10 Follow‐up: 12 months (Higher score is worse) | Mean pain score in control groups was 5.2 | Mean pain in intervention groups was | 115 (1 study) | ⊕⊕⊝⊝ | MD = 0.00 (95% CI ‐0.84 to 0.84) Absolute percent change = 0% (95% CI ‐8.4 to 8.4) Relative percent change = 0% (95% CI ‐1.6 to 1.6) NNTB = not statistically significant | |
| Knee function (HSS) Scale from 0 to 100 (Higher score is better) | Mean function score in control groups was | Mean function in intervention groups was 1.00 higher (2.98 lower to 4.98 higher) | 110 (1 study) | ⊕⊕⊝⊝ | MD = 1.00 (95% CI ‐2.98 to 4.98) Absolute percent change = 1.0% (95% CI 3.0 to 5.0) Relative percent change = 0.01% (95% CI 0.05 to 0.07) NNTB = not statistically significant | |
| Quality of life (EQ‐5D) Scale from 0 to 100 Follow‐up: 12 months (Higher score is better) | Mean health‐related quality of life score in control groups was | Mean health‐related quality of life score in intervention groups was | 117 (1 study) | ⊕⊕⊝⊝ | MD = 0.04 (95% CI ‐0.12 to 0.04) Absolute percent change = 0.04% (95% CI ‐0.12 to 0.04) Relative percent change = 0.07% (95% CI ‐0.2 to 0.07) NNTB = not statistically significant | |
| Total number of adverse events (withdrawals due to lack of effect)c Follow‐up: 12 months | Low‐risk population | RR 1.63 | 117 (1 study) | ⊕⊕⊝⊝ | Absolute percent change = 15% (95% CI ‐1% to 32%) Relative percent change = 63% (95% CI ‐6% to 182%) NNTB = not statistically significant | |
| 246 per 1000 | 400 per 1000 | |||||
| Lateral‐wedge insole compared with neutral insole | ||||||
| Pain on walking (NRS) Scale from 0 to 10 (Higher score is worse) | Mean pain on walking score in control groups was | Mean pain on walking in intervention groups was 0.1 higher (0.45 higher to 0.65 lower) | 224 (2 studies) | ⊕⊕⊕⊝ | MD = 0.10 (95% CI ‐0.45 to 0.65) Absolute percent change = 1.0% (95% CI 4.5 to ‐6.5) Relative percent change = 3.8% (95% CI 1.7 to ‐25.0) NNTB = not statistically significant | |
| Physical function (WOMAC) ‐ Scale from 0 to 100 (Higher score is better) | Mean function score in control groups was | Mean function in intervention groups was | 358 (3 studies) | ⊕⊕⊕⊝ | MD = 0.94 (95% CI ‐2.98 to 4.87) Absolute percent change = 0.9% (95% CI ‐3.0 to 4.9) Relative percent change = 2.6% (95% CI ‐8.1 to 13.3) NNTB = not statistically significant | |
| Health‐related quality of life (HRQoL) Scale from 0 to 1.0 Follow‐up: 12 months (Higher score is better) | Mean health‐related quality of life score in control groups was 0.7 | Mean health‐related quality of life score in intervention groups was 0.01 lower (0.05 lower to 0.03 higher) | 179 (1 study) | ⊕⊕⊕⊝ | MD = 0.00 (95% CI ‐0.06 to 0.06) Absolute percent change = 1.0% (95% CI ‐5.0 to 3.0) Relative percent change = 1.4% (95% CI ‐7.1 to 4.3) NNTB = not statistically significant | |
| *The basis for the assumed risk (e.g. median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADE Working Group grades of evidence. | ||||||
| aLimitations in design and implementation of available studies suggest high likelihood of bias. bImprecision: Results are based on only one study with 117 people. cMany participants stopped their initial treatment because of lack of effect. | ||||||
| Valgus knee brace compared with no brace for varus medial osteoarthritis of the knee | |||||
| Patient or population: patients with varus medial osteoarthritis of the knee | |||||
| Outcomes | Illustrative comparative risks* (95% CI) | Number of participants | Quality of the evidence | Comments | |
| Assumed risk | Corresponding risk | ||||
| No brace | Valgus knee brace | ||||
| Pain (Higher score is worse) | Mean pain score in control groups was | Mean pain on walking in intervention groups was equal (0.84 lower to 0.84 higher) | 115 (1 study) | ⊕⊕⊝⊝ Lowa,b | MD = 0.00 (95% CI ‐0.84 to 0.84) Absolute percent change = 0% Relative percent change = 0% NNTB = not statistically significant |
| Stiffness | See comment | See comment | Not estimablec | See comment | Outcome not reported in included studies |
| Function HSS: scale from 0 to 100 (Higher score is better) | Mean function score in control groups was 69 | Mean function in intervention groups was 1.00 higher (2.98 lower to 4.98 higher) | 110 (1 study) | ⊕⊕⊝⊝ Lowa,b | MD = 1.00 (95% CI ‐2.98 to 4.98) Absolute percent change = 1.0% (95% CI 3.0 to 5.0) Relative percent change = 0.01% (95% CI 0.05 to 0.07) NNTB = not statistically significant |
| Health‐related quality of life EQ‐5S: scale from 0 to 100 Follow‐up: 12 months (Higher score is better) | Mean health‐related quality of life score in control groups was 0.6 | Mean health‐related quality of life score in intervention groups was 0.04 lower (0.12 lower to 0.04 higher) | 117 (1 study) | ⊕⊕⊝⊝ Lowa,b | MD = 0.04 (95% CI ‐0.12 to 0.04) Absolute percent change = 0.04% (95% CI ‐0.12 to 0.04) Relative percent change = 0.07% (95% CI ‐0.2 to 0.07) NNTB = not statistically significant |
| Treatment failure | See comment | See comment | Not estimablec | See comment | Outcome not reported in included studies |
| Serious adverse events | See comment | See comment | Not estimablec | See comment | Outcome not reported in included studies |
| Total number of adverse events (withdrawals due to lack of effect)d | Study population | 117 (1 study) | ⊕⊕⊝⊝ Lowa,b | RR = 1.63 (95% CI 0.94 to 2.82) Absolute percent change = 15% (95% CI ‐1% to 32%) Relative percent change = 63% NNTB = not statistically significant | |
| 400 per 1000 | 246 per 1000 | ||||
| *The basis for the assumed risk (e.g. median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | |||||
| GRADE Working Group grades of evidence. | |||||
| aLimitations in design and implementation of available studies suggest high likelihood of bias. bImprecision: Results are based on only one study with 117 participants. cNo useful data were available. dMany participants stopped their initial treatment because of lack of effect. | |||||
| Lateral wedge insole compared with neutral insole for varus medial osteoarthritis of the knee | |||||
| Patient or population: patients with varus medial osteoarthritis of the knee | |||||
| Outcomes | Illustrative comparative risks* (95% CI) | Number of participants | Quality of the evidence | Comments | |
| Assumed risk | Corresponding risk | ||||
| Neutral insole | Lateral wedge insole | ||||
| Pain (Higher score is worse) | Mean pain on walking score in control groups was 2.6 | Mean pain on walking in intervention groups was 0.1 higher (0.45 higher to 0.65 lower) | 224 | ⊕⊕⊕⊝ | MD = 0.10 (95% CI ‐0.45 to 0.65) Absolute percent change = 1.0% (95% CI 4.5 to ‐6.5) Relative percent change = 3.8% (95% CI 1.7 to ‐25.0) NNTB = not statistically significant |
| Stiffness (Higher score is better) | Mean stiffness score in control groups was 41.6 | Mean stiffness in intervention groups was 0.07 higher (4.96 lower to 5.1 higher) | 358 (3 studies) | ⊕⊕⊕⊝ | MD = 0.07 (95% CI ‐4.96 to 5.10) Absolute percent change = 0.1% (95% CI ‐5.0 to 5.1) Relative percent change = 0.2% (95% CI ‐11.9 to 12.3) NNTB = not statistically significant |
| Function WOMAC: scale from 0 to 100 (Higher score is better) | Mean function score in control groups was 36.6 | Mean function in intervention groups was 0.94 higher (2.98 lower to 4.87 higher) | 358 (3 studies) | ⊕⊕⊕⊝ | MD = 0.94 (95% CI ‐2.98 to 4.87) Absolute percent change = 0.9% (95% CI ‐3.0 to 4.9) Relative percent change = 2.6% (95% CI ‐8.1 to 13.3) NNTB = not statistically significant |
| Health‐related quality of life HRQoL: scale from 0 to 1.0 Follow‐up: 12 months (Higher score is better) | Mean health‐related quality of life score in control groups was 0.7 | Mean health‐related quality of life score in intervention groups was 0.01 lower (0.05 lower to 0.03 higher) | 179 (1 study) | ⊕⊕⊕⊝ | MD = 0.00 (95% CI ‐0.06 to 0.06) Absolute percent change = 1.0% (95% CI ‐5.0 to 3.0) Relative percent change = 1.4% (95% CI ‐7.1 to 4.3) NNTB = not statistically significant |
| Treatment failure | See comment | See comment | Not estimablec | See comment | Outcome not reported in included studies |
| Serious adverse events | See comment | See comment | Not estimablec | See comment | Outcome not reported in included studies |
| Total number of adverse events | See comment | See comment | Not estimablec | See comment | Outcome not reported in included studies |
| *The basis for the assumed risk (e.g. median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | |||||
| GRADE Working Group grades of evidence. | |||||
| aDowngraded for limitations in design and implementation of available studies suggesting high likelihood of bias. bDowngraded for imprecision: Results were based on only one study with 179 participants. cNo useful data were available. | |||||
| Valgus knee brace compared with lateral wedge insole for varus medial osteoarthritis of the knee | |||||
| Patient or population: patients with varus medial osteoarthritis of the knee Settings: general hospital Intervention: valgus knee brace Comparison: lateral wedge insole | |||||
| Outcomes | Illustrative comparative risks* (95% CI) | Number of participants | Quality of the evidence | Comments | |
| Assumed risk | Corresponding risk | ||||
| Lateral wedge insole | Valgus knee brace | ||||
| Pain VAS: scale from 0 to 10 Follow‐up: 6 months (Higher score is worse) | Mean pain score in control groups was 4.8 | Mean pain score in intervention groups was 0.2 lower (1.15 lower to 0.75 higher) | 91 (1 study) | ⊕⊕⊝⊝ Lowa,b | MD = ‐0.20 (95% CI ‐1.15 to 0.75) Absolute percent change = ‐2.0% (95% CI ‐11.5 to 7.5) Relative percent change = ‐4.2% (95% CI ‐24.0 to 15.6) NNTB = not statistically significant |
| Stiffness | See comment | See comment | Not estimable | See comment | Outcome not reported in included studies |
| Function WOMAC: scale from 0 to 100 Follow‐up: 6 months (Higher score is better) | Mean function score in control groups was 50.7 | Mean function score in intervention groups was 0.1 higher (7.26 lower to 0.75 higher) | 91 (1 study) | ⊕⊕⊝⊝ Lowa,b | MD = 0.10 (95% CI ‐7.26 to 7.46) Absolute percent change = 0.1% (95% CI ‐7.26 to 0.75) Relative percent change = 0.2% (95% CI ‐14.3 to 1.5) NNTB = not statistically significant |
| Health‐related quality of life | See comment | See comment | Not estimablec | See comment | Outcome not reported in included studies |
| Treatment failure | See comment | See comment | Not estimablec | See comment | Outcome not reported in included studies |
| Serious adverse events | See comment | See comment | Not estimablec | See comment | Outcome not reported in included studies |
| Total number of adverse events | See comment | See comment | Not estimablec | See comment | Outcome not reported in included studies |
| *The basis for the assumed risk (e.g. median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | |||||
| GRADE Working Group grades of evidence. | |||||
| aDowngraded for imprecision: Results were based on only one study with 91 participants. bDowngraded for limitations in design and implementation of available studies suggesting high likelihood of bias. cNo useful data were available. | |||||
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1 Pain (VAS) Show forest plot | 2 | Mean Difference (IV, Random, 95% CI) | Subtotals only | |
| 1.1 6 months | 1 | 115 | Mean Difference (IV, Random, 95% CI) | ‐0.10 [‐0.91, 0.71] |
| 1.2 9 months | 1 | 40 | Mean Difference (IV, Random, 95% CI) | ‐2.80 [‐3.58, ‐2.02] |
| 1.3 12 months | 1 | 115 | Mean Difference (IV, Random, 95% CI) | 0.0 [‐0.84, 0.84] |
| 2 Knee function (HSS) Show forest plot | 1 | Mean Difference (IV, Random, 95% CI) | Subtotals only | |
| 2.1 6 months | 1 | 110 | Mean Difference (IV, Random, 95% CI) | 1.40 [‐2.36, 5.16] |
| 2.2 12 months | 1 | 110 | Mean Difference (IV, Random, 95% CI) | 1.0 [‐2.98, 4.98] |
| 3 Walking distance (km) Show forest plot | 2 | Mean Difference (IV, Random, 95% CI) | Subtotals only | |
| 3.1 6 months | 1 | 116 | Mean Difference (IV, Random, 95% CI) | ‐0.10 [‐1.32, 1.12] |
| 3.2 9 months | 1 | 40 | Mean Difference (IV, Random, 95% CI) | 1.20 [0.95, 1.45] |
| 3.3 12 months | 1 | 117 | Mean Difference (IV, Random, 95% CI) | 0.40 [‐0.87, 1.67] |
| 4 Quality of life (EQ‐5D) Show forest plot | 1 | Mean Difference (IV, Random, 95% CI) | Subtotals only | |
| 4.1 6 months | 1 | 117 | Mean Difference (IV, Random, 95% CI) | ‐0.05 [‐0.14, 0.04] |
| 4.2 12 months | 1 | 117 | Mean Difference (IV, Random, 95% CI) | ‐0.04 [‐0.12, 0.04] |
| 5 Total adverse events Show forest plot | 1 | 117 | Risk Ratio (M‐H, Random, 95% CI) | 1.63 [0.94, 2.82] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1 Walking distance Show forest plot | 1 | 40 | Mean Difference (IV, Random, 95% CI) | 0.5 [0.23, 0.77] |
| 1.1 9 months | 1 | 40 | Mean Difference (IV, Random, 95% CI) | 0.5 [0.23, 0.77] |
| 2 WOMAC 6 months Show forest plot | 1 | 91 | Mean Difference (IV, Random, 95% CI) | 0.10 [‐7.26, 7.46] |
| 3 Pain (VAS) Show forest plot | 2 | Mean Difference (IV, Random, 95% CI) | Subtotals only | |
| 3.1 6 months | 1 | 91 | Mean Difference (IV, Random, 95% CI) | ‐0.20 [‐1.15, 0.75] |
| 3.2 9 months | 1 | 40 | Mean Difference (IV, Random, 95% CI) | ‐2.80 [‐3.58, ‐2.02] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1 Pain (VAS) Show forest plot | 1 | 40 | Mean Difference (IV, Random, 95% CI) | ‐1.60 [‐2.31, ‐0.89] |
| 2 Walking distance (km) Show forest plot | 1 | 40 | Mean Difference (IV, Random, 95% CI) | 0.70 [0.52, 0.88] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1 Pain (NRS) Show forest plot | 2 | Mean Difference (IV, Random, 95% CI) | Subtotals only | |
| 1.1 Pain on walking 1 month | 1 | 59 | Mean Difference (IV, Random, 95% CI) | ‐0.10 [‐0.97, 0.77] |
| 1.2 Maximum pain change with stairs 1 month | 1 | 59 | Mean Difference (IV, Random, 95% CI) | 0.0 [0.0, 0.0] |
| 1.3 Average pain at rest 12 months | 1 | 179 | Mean Difference (IV, Random, 95% CI) | ‐0.4 [‐1.06, 0.26] |
| 1.4 Pain on walking 12 months | 2 | 224 | Mean Difference (IV, Random, 95% CI) | 0.10 [‐0.45, 0.65] |
| 1.5 Maximum pain change with stairs 12 months | 1 | 45 | Mean Difference (IV, Random, 95% CI) | 0.0 [‐0.58, 0.58] |
| 2 Pain (WOMAC) Show forest plot | 3 | Mean Difference (IV, Random, 95% CI) | Subtotals only | |
| 2.1 1 month | 2 | 206 | Mean Difference (IV, Random, 95% CI) | 1.17 [‐7.69, 10.03] |
| 2.2 3 months | 1 | 147 | Mean Difference (IV, Random, 95% CI) | 5.5 [‐1.95, 12.95] |
| 2.3 6 months | 1 | 147 | Mean Difference (IV, Random, 95% CI) | 6.40 [‐0.07, 12.87] |
| 2.4 12 months | 3 | 358 | Mean Difference (IV, Random, 95% CI) | 0.89 [‐2.89, 4.67] |
| 2.5 24 months | 1 | 106 | Mean Difference (IV, Random, 95% CI) | 2.80 [‐6.12, 11.72] |
| 3 Stiffness (WOMAC) Show forest plot | 3 | Mean Difference (IV, Random, 95% CI) | Subtotals only | |
| 3.1 1 month | 2 | 206 | Mean Difference (IV, Random, 95% CI) | 5.74 [‐0.49, 11.97] |
| 3.2 3 months | 1 | 147 | Mean Difference (IV, Random, 95% CI) | 4.20 [‐2.61, 11.01] |
| 3.3 6 months | 1 | 147 | Mean Difference (IV, Random, 95% CI) | 6.0 [‐0.48, 12.48] |
| 3.4 12 months | 3 | 358 | Mean Difference (IV, Random, 95% CI) | 0.07 [‐4.96, 5.10] |
| 3.5 24 months | 1 | 106 | Mean Difference (IV, Random, 95% CI) | 1.80 [‐7.22, 10.82] |
| 4 Physical function (WOMAC) Show forest plot | 3 | Mean Difference (IV, Random, 95% CI) | Subtotals only | |
| 4.1 1 month | 2 | 206 | Mean Difference (IV, Random, 95% CI) | 2.47 [‐2.49, 7.44] |
| 4.2 3 months | 1 | 147 | Mean Difference (IV, Random, 95% CI) | 5.20 [‐0.94, 11.34] |
| 4.3 6 months | 1 | 147 | Mean Difference (IV, Random, 95% CI) | 6.0 [‐0.48, 12.48] |
| 4.4 12 months | 3 | 358 | Mean Difference (IV, Random, 95% CI) | 0.94 [‐2.98, 4.87] |
| 4.5 24 months | 1 | 106 | Mean Difference (IV, Random, 95% CI) | ‐0.40 [‐9.47, 8.67] |
| 5 Health‐related quality of life Show forest plot | 1 | 179 | Mean Difference (IV, Random, 95% CI) | 0.0 [‐0.06, 0.06] |
| 6 Physical activity scale for the elderly Show forest plot | 1 | 179 | Mean Difference (IV, Random, 95% CI) | 15.0 [‐8.45, 38.45] |
| 7 Number of steps taken per day Show forest plot | 1 | 179 | Mean Difference (IV, Random, 95% CI) | 1371.0 [38.53, 2703.47] |
| 8 Global patient assessment at 24 months Show forest plot | 1 | 106 | Mean Difference (IV, Random, 95% CI) | 1.60 [‐7.41, 10.61] |
| 9 Compliance at 6 months Show forest plot | 1 | 156 | Risk Ratio (M‐H, Random, 95% CI) | 1.18 [1.01, 1.38] |
| 10 Time for negotiation of stairs Show forest plot | 1 | Mean Difference (IV, Random, 95% CI) | Subtotals only | |
| 10.1 1 month | 1 | 59 | Mean Difference (IV, Random, 95% CI) | 1.10 [‐1.18, 3.38] |
| 10.2 12 months | 1 | 45 | Mean Difference (IV, Random, 95% CI) | ‐0.30 [‐3.06, 2.46] |
| 11 6‐Minute walk distance Show forest plot | 1 | Mean Difference (IV, Random, 95% CI) | Subtotals only | |
| 11.1 1 month | 1 | 59 | Mean Difference (IV, Random, 95% CI) | 23.00 [‐18.61, 64.61] |
| 11.2 12 months | 1 | 45 | Mean Difference (IV, Random, 95% CI) | ‐25.20 [‐77.37, 26.97] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1 Pain (VAS) Show forest plot | 1 | Mean Difference (IV, Random, 95% CI) | Subtotals only | |
| 1.1 8 weeks | 1 | 90 | Mean Difference (IV, Random, 95% CI) | ‐9.20 [‐18.28, ‐0.12] |
| 1.2 6 months | 1 | 61 | Mean Difference (IV, Random, 95% CI) | ‐11.80 [‐22.04, ‐1.56] |
| 1.3 24 months | 1 | 42 | Mean Difference (IV, Random, 95% CI) | ‐2.0 [‐13.34, 9.34] |
| 2 Lequesne index Show forest plot | 1 | Mean Difference (IV, Random, 95% CI) | Subtotals only | |
| 2.1 8 weeks | 1 | 90 | Mean Difference (IV, Random, 95% CI) | ‐0.60 [‐2.81, 1.61] |
| 2.2 6 months | 1 | 61 | Mean Difference (IV, Random, 95% CI) | ‐1.5 [‐4.23, 1.23] |
| 2.3 24 months | 1 | 42 | Mean Difference (IV, Random, 95% CI) | ‐2.3 [‐5.45, 0.85] |
| 3 FTA ‐ angle Show forest plot | 1 | Mean Difference (IV, Random, 95% CI) | Subtotals only | |
| 3.1 8 weeks | 1 | 90 | Mean Difference (IV, Random, 95% CI) | ‐1.30 [‐3.45, 0.85] |
| 3.2 6 months | 1 | 61 | Mean Difference (IV, Random, 95% CI) | ‐1.00 [‐5.84, ‐0.16] |
| 3.3 24 months | 1 | 42 | Mean Difference (IV, Random, 95% CI) | ‐2.70 [‐5.13, ‐0.27] |
| 4 Side effects at 8 weeks Show forest plot | 1 | 90 | Risk Ratio (M‐H, Fixed, 95% CI) | 5.74 [0.72, 45.77] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1 FTA angle Show forest plot | 1 | 88 | Mean Difference (IV, Random, 95% CI) | ‐0.90 [‐2.89, 1.09] |
| 2 Aggregate score Show forest plot | 1 | 88 | Mean Difference (IV, Random, 95% CI) | ‐1.40 [‐3.57, 0.77] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1 VAS rest Show forest plot | 1 | 30 | Mean Difference (IV, Random, 95% CI) | ‐0.40 [‐2.16, 1.36] |
| 2 VAS movement Show forest plot | 1 | 30 | Mean Difference (IV, Fixed, 95% CI) | ‐2.2 [‐4.04, ‐0.36] |
| 3 VAS night Show forest plot | 1 | 30 | Mean Difference (IV, Fixed, 95% CI) | ‐1.50 [‐3.12, 0.12] |
| 4 WOMAC Show forest plot | 1 | 30 | Mean Difference (IV, Fixed, 95% CI) | ‐6.70 [‐17.09, 3.69] |
| 5 Lequesne Show forest plot | 1 | 30 | Mean Difference (IV, Fixed, 95% CI) | ‐2.40 [‐5.28, 0.48] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1 Pain (WOMAC) Show forest plot | 1 | Mean Difference (IV, Random, 95% CI) | Subtotals only | |
| 1.1 6 months | 1 | 60 | Mean Difference (IV, Random, 95% CI) | ‐3.70 [‐8.57, 1.17] |
| 1.2 12 months | 1 | 55 | Mean Difference (IV, Random, 95% CI) | ‐1.10 [‐6.43, 4.23] |
| 2 Stiffness (WOMAC) Show forest plot | 1 | Mean Difference (IV, Random, 95% CI) | Subtotals only | |
| 2.1 6 months | 1 | 60 | Mean Difference (IV, Random, 95% CI) | ‐1.90 [‐4.34, 0.54] |
| 2.2 12 months | 1 | 44 | Mean Difference (IV, Random, 95% CI) | ‐1.40 [‐4.52, 1.72] |
| 3 Physical function (WOMAC) Show forest plot | 1 | Mean Difference (IV, Random, 95% CI) | Subtotals only | |
| 3.1 6 months | 1 | 60 | Mean Difference (IV, Random, 95% CI) | ‐6.90 [‐24.14, 10.34] |
| 3.2 12 months | 1 | 55 | Mean Difference (IV, Random, 95% CI) | ‐4.90 [‐24.54, 14.74] |
