Insoles for prevention and treatment of back pain

Tali Sahar; Matan J Cohen; Vered Ne'eman; Leonid Kandel; Daniel Oluwafemi Odebiyi; Ishay Lev; Mayer Brezis; Amnon Lahad

doi:10.1002/14651858.CD005275.pub2

Plantillas para la prevención y el tratamiento del dolor de espalda

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Referencias

References to studies included in this review

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estudios excluidos
otras referencias

Basford JR, Smith MA. Shoe insoles in the workplace. Orthopedics 1988;11:285‐8.

Larsen K, Weidich F, Leboeuf‐Yde C. Can custom‐made biomechanic shoe orthoses prevent problems in the back and lower extremities? A randomized, controlled intervention trial of 146 military conscripts. J Manipulative Physiol Ther 2002;25:326‐31.

Milgrom C, Finestone A, Lubovsky O, Zin D, Lahad A. A controlled randomized study of the effect of training with orthoses on the incidence of weight bearing induced back pain among infantry recruits. Spine 2005;30:272‐5.

Schwellnus MP, Jordaan G, Noakes TD. Prevention of common overuse injuries by the use of shock absorbing insoles. A prospective study. Am J Sports Med 1990;18:636‐41.

Shabat S, Gefen T, Nyska M, Folman Y, Gepstein R. The effect of insoles on the incidence and severity of low back pain among workers whose job involves long‐distance walking. Eur Spine J 2005;14:546‐50.

Tooms RE, Griffin JW, Green S, Cagle K. Effect of viscoelastic insoles on pain. Orthopedics 1987;10:1143‐7.

References to studies excluded from this review

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estudios incluidos
otras referencias

Dananberg HJ, Guiliano M. Chronic Low‐Back Pain and Its Response to Custom‐Made Foot Othroses. J Am Podiatr Med Assoc 1999;89:109‐17.

Sobel E, Levitz SJ, Caselli MA, Christos PJ, Rosenblum J. The effect of customized insoles on the reduction of postwork discomfort. J Am Podiatr Med Assoc 2001;91:515‐20.

Wosk J, Voloshin AS. Low back pain: conservative treatment with artificial shock absorbers. Arch Phys Med Rehabil 1985;66:145‐8.

Additional references

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estudios incluidos
estudios excluidos

Alderson P, Green S, Higgins JPT, editors. Cochrane Reviewers’ Handbook 4.2.2 (updated December 2003). The Cochrane Library. Chichester, UK: John Wiley & Sons, Ltd, 2004, issue 1.

Google Scholar

Andersson GBJ. Low back pain. In: Rakel RE, Bope ET editor(s). Conn's Current Therapy 2004. 6th Edition. Elsevier Science, 2003.

Google Scholar

Ball KA, Afheldt MJ. Evolution of foot orthotics ‐ Part 1: Coherent theory or coherent practice?. J Manipulative Physiol Ther 2002;25:116‐24.

Bird AR, Payne CB. Foot function and low back pain. The foot 1999;9(4):175‐80.

Boer H, Seydel ER. Medical opinions, beliefs and prescription of orthopaedic footwear: a survey of Dutch orthopaedists and rehabilitation practitioners. Clin Rehabil 1998;12(3):245‐53.

Brady RJ, Dean JB, Skinner TM, Gross MT. Limb length inequality: clinical implications for assessment and intervention. J Orthop Sports Phys Ther 2003;33(5):221‐34.

Farrar JT, Young JP, LaMoreaux L, Werth JL, Poole RM. Clinical importance of changes in chronic pain intensity measured on an 11‐point numerical pain rating scale. Pain 2001;94:149‐158.

Loney PL, Stratford PW. The prevalence of low back pain in adults: a methodological review of the literature. Phys Ther 1999;79(4):384‐96.

Oxman AD, Sackett DL, Guyatt GH. Users' guides to the medical literature. I. How to get started. The Evidence‐Based Medicine Working Group. JAMA 1993;270(17):2093‐5.

Robinson KA, Dickerson K. Development of a highly sensitive strategy for the retrieval of reports of controlled trials using PubMed. Intern J Clin Epi 2002;31:150‐3.

Shekelle PG, Andersson G, Bombardier C, Cherkin D, Deyo R, Keller R, et al. A brief introduction to the critical reading of the clinical literature. Spine 1994;19:2028S‐31S.

Sibbald B, Roberts C. Understanding controlled trials: Crossover trials. BMJ 1998;316:1719‐20.

Veterans Health Administration, Department of Defense. Clinical practice guideline for the management of low back pain or sciatica in the primary care setting. U.S. Department of Veterans Affairs website. Washington (DC): Department of Veterans Affairs (U.S.), 1999.

van Tulder M, Furlan A, Bombardier C, Bouter L, the Editorial Board of the Cochrane Collaboration Back Review Group. Updated Method Guidelines for Systematic Reviews in the Cochrane Collaboration Back Review Group. Spine 2003;28(12):1290‐9.

Waddell G. Low back pain: a twentieth century healh‐care enigma. Spine 1996;21(24):2820‐5.

Characteristics of studies

Characteristics of included studies [ordered by study ID]

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estudios excluidos

Basford 1988

Methods	RCT ‐ cross‐over No Blinding Mixed population (primary prevention + treatment) ‐ no participant was under medical care for back pain, but 39 had mild‐moderate back pain on the initial questionnaire
Participants	United States 96 Women, non‐supervisory personnel working in laboratories and patient reception , standing 75% of working hours Average age ‐ 39 (18‐68) Drop‐outs ‐ 32/96 (33%) Footwear: 66 ‐ Oxford, 19 ‐ Jogging, 11 ‐ other
Interventions	Non Customized insoles materials:Commercially available Viscoelastic polyurethane Duration of intervention: 5 weeks and 5 weeks cross over Control intervention: No treatment
Outcomes	Self reported incidence, pain intensity ‐ visual analogue scale (VAS) ‐ maximum pain relief ‐ 4.8 back pain relief from insole use ‐ 2.1/4.8 (p<.0001) (actual‐use analysis)
Notes	adverse affects ‐ 25 refused to participate because feeling unpleasant and too tight . 1/38 ‐ pain increased. We were not able to extract the numbers of patients with or without back pain after each intervention period. The required data were not available. Methodological quality: low ( 2/11 criteria) Major methodological flaw ‐ Inappropriate analysis for cross‐over trial (One comparison was done instead of two sets of comparisons).
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Low risk
Allocation concealment?	High risk	C ‐ Inadequate
Blinding? All outcomes ‐ patients?	High risk
Blinding? All outcomes ‐ providers?	High risk
Blinding? All outcomes ‐ outcome assessors?	Unclear risk	Unclear from text
Incomplete outcome data addressed? All outcomes ‐ drop‐outs?	High risk	Drop‐outs ‐ 32/96 (33%)
Incomplete outcome data addressed? All outcomes ‐ ITT analysis?	High risk
Similarity of baseline characteristics?	Unclear risk	Unclear from text
Co‐interventions avoided or similar?	Low risk
Compliance acceptable?	High risk
Timing outcome assessments similar?	High risk

Larsen 2002

Methods	RCT Blinding of health professionals Primary prevention
Participants	Denmark 146 Infantry recruits (M:F ‐ 145:1) Average age ‐ 18‐24 Drop‐outs ‐ Intervention ‐ 10/77 + 9/77 non‐compliant and Control ‐ 6/69
Interventions	Customized insoles Materials: semirigid insoles (Fromthotics) Duration of intervention: 3 months (60 working days) Control intervention: No intervention
Outcomes	self reported incidence and number of days off‐duty Back pain ‐ Intervention‐ 9/63, control 9/58 Differences were not statistically significant in intention to treat analysis and per protocol analysis.
Notes	Military setting Methodological quality: high (8/11)
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Low risk
Allocation concealment?	Low risk	A ‐ Adequate
Blinding? All outcomes ‐ patients?	High risk
Blinding? All outcomes ‐ providers?	Low risk
Blinding? All outcomes ‐ outcome assessors?	Unclear risk	Unclear from text
Incomplete outcome data addressed? All outcomes ‐ drop‐outs?	Low risk	Drop‐outs ‐ Intervention ‐ 10/77 + 9/77 non‐compliant and Control ‐ 6/69
Incomplete outcome data addressed? All outcomes ‐ ITT analysis?	Low risk
Similarity of baseline characteristics?	Unclear risk	Unclear from text
Co‐interventions avoided or similar?	Low risk
Compliance acceptable?	Low risk
Timing outcome assessments similar?	Low risk

Milgrom 2005

Methods	RCT Blinding Primary prevention
Participants	Israel 404 Male Infantry recruits Average age ‐ 18.8 Drop‐outs ‐ group 1 ‐ 78/129, group 2 ‐ 51/126, group 3 ‐ 73/126 Footwear ‐ Standard military footwear (boot with leather upper and rubber sole)
Interventions	Customized insoles Group 1 ‐ customized semirigid biomechanical insoles Group 2 ‐ soft biomechanical insoles Group 3 ‐ sham inserts without supportive or shock absorbing qualities materials: semirigid biomechanical insoles, soft biomechanical insoles Duration of intervention: 14 weeks Control intervention: Simple shoe inserts without supportive or shock absorbing qualities
Outcomes	Review by the senior author every two weeks ‐ questions about back pain + physical examination + monitoring for compliance back pain ‐ Biomechanical ‐ 16/129, Soft custom ‐ 17/126, Placebo ‐ 18/126 Differences were not statistically significant in intention to treat analysis and per protocol analysis
Notes	Military setting Methodological quality: high ( 6/11 criteria) Major methodological flaw ‐ very high drop‐out rate
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Low risk
Allocation concealment?	High risk	C ‐ Inadequate
Blinding? All outcomes ‐ patients?	High risk
Blinding? All outcomes ‐ providers?	High risk
Blinding? All outcomes ‐ outcome assessors?	Low risk
Incomplete outcome data addressed? All outcomes ‐ drop‐outs?	High risk	Drop‐outs ‐ group 1 ‐ 78/129, group 2 ‐ 51/126, group 3 ‐ 73/126
Incomplete outcome data addressed? All outcomes ‐ ITT analysis?	Low risk
Similarity of baseline characteristics?	Low risk
Co‐interventions avoided or similar?	Low risk
Compliance acceptable?	High risk
Timing outcome assessments similar?	Low risk

Schwellnus 1990

Methods	RCT, No Blinding Primary prevention
Participants	South Africa 1511 military recruits (250 ‐ intervention, 1261‐ control) Average age ‐ 18.5 Drop‐outs ‐ 13/250 and 109/1260 (due to transfers to other units) Footwear ‐ Standard military footwear (boot with leather upper and rubber sole)
Interventions	Non Customized insoles materials: Neoprene ‐ impregnated with nitrogen bubbles covered with stretch nylon Duration of intervention: 9 Weeks Control intervention: No treatment
Outcomes	Physician diagnosis after first complaint by participant Mean incidence per 1000 subjects per week Acute back pain ‐ Intervention ‐ 0.7%, Control ‐ 1.6% Chronic back pain ‐ Intervention ‐ 1.2%, Control ‐ 2.4% Differences were not statistically significant Main outcome ‐ injuries leading to self referral for medical care and confirmed by standardized medical diagnosis.
Notes	Military setting There is a report regarding back pain, but it was not the focus of this study. Took place among South‐African army recruits prior to 1990. No data specifying sex ratios were provided and we found that females were recruited to the South‐African army since the 1970s (http://en.wikipedia.org/wiki/South_African_Army) Methodological quality: middle (5/11 criteria).
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	Unclear from text
Allocation concealment?	Unclear risk	B ‐ Unclear
Blinding? All outcomes ‐ patients?	High risk
Blinding? All outcomes ‐ providers?	High risk
Blinding? All outcomes ‐ outcome assessors?	Unclear risk	Unclear from text
Incomplete outcome data addressed? All outcomes ‐ drop‐outs?	Low risk	Drop‐outs ‐ 13/250 and 109/1260 (due to transfers to other units)
Incomplete outcome data addressed? All outcomes ‐ ITT analysis?	High risk
Similarity of baseline characteristics?	Low risk
Co‐interventions avoided or similar?	Low risk
Compliance acceptable?	Low risk
Timing outcome assessments similar?	Low risk

Shabat 2005

Methods	RCT ‐ cross over Blinding Mixed population (secondary prevention +treatment)
Participants	Israel 75 postmen whose job includes walking long distances and who reported that they suffered from back pain 60 agreed to participate in the study (M:F ‐ 25:35) Average age ‐ 39.14 Drop‐outs ‐ 15 did not agree to participate. 2/60 dropped from follow up Compliance:
Interventions	Customized insoles materials: viscoelastic polymer material Duration of intervention: 5 weeks Control intervention: Placebo non‐customized insoles
Outcomes	MILLION questionnaire for evaluation of low back pain + 10‐point pain scale Scores decreased from 5.46 to 3.96 after use of the real insole, and to 5.11 after use of the placebo insoles (P < 0.0001). Most of the participants said they would have liked to continue with the use of either of the insoles. 81% of them preferred the true insoles over the placebo insoles.
Notes	We were not able to extract the numbers of patients with or without back pain after each intervention period. The required data were not available. Methodological quality: high ( 6/11 criteria) Major methodological flaw ‐ Inappropriate analysis for cross‐over trial (One comparison was done instead of two sets of comparisons).
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	High risk
Allocation concealment?	Unclear risk	B ‐ Unclear
Blinding? All outcomes ‐ patients?	Low risk
Blinding? All outcomes ‐ providers?	Low risk
Blinding? All outcomes ‐ outcome assessors?	Low risk
Incomplete outcome data addressed? All outcomes ‐ drop‐outs?	Low risk	Drop‐outs ‐ 15 did not agree to participate. 2/60 dropped from follow up
Incomplete outcome data addressed? All outcomes ‐ ITT analysis?	High risk
Similarity of baseline characteristics?	Low risk
Co‐interventions avoided or similar?	Unclear risk	Unclear from text
Compliance acceptable?	Low risk
Timing outcome assessments similar?	High risk

Tooms 1987

Methods	RCT No Blinding Mixed population (primary and secondary prevention + treatment)
Participants	United States 100 Nursing students, standing 3 days a week for 8 hours a day Average age ‐ 22.8 Drop‐outs ‐ 1/100
Interventions	Non Customized insoles materials: commercially available Viscoelastic polyurethane Duration of intervention: 5 weeks Control intervention: No intervention
Outcomes	Self reported incidence, pain intensity ‐ visual analogue scale (VAS) Shift of pain from back plus lower extremity to lower extremities only.
Notes	Methodological quality: low ( 3/11 criteria)
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	Unclear from text
Allocation concealment?	High risk	C ‐ Inadequate
Blinding? All outcomes ‐ patients?	High risk
Blinding? All outcomes ‐ providers?	Unclear risk	Unclear from text
Blinding? All outcomes ‐ outcome assessors?	Unclear risk	Unclear from text
Incomplete outcome data addressed? All outcomes ‐ drop‐outs?	High risk	Drop‐outs ‐ 1/100
Incomplete outcome data addressed? All outcomes ‐ ITT analysis?	High risk
Similarity of baseline characteristics?	Low risk
Co‐interventions avoided or similar?	Low risk
Compliance acceptable?	High risk
Timing outcome assessments similar?	Low risk

Characteristics of excluded studies [ordered by study ID]

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estudios incluidos

Study	Reason for exclusion
Dananberg 1999	Not a RCT
Sobel 2001	Not a RCT
Wosk 1985	Retrospective report No randomisation

Data and analyses

Open in table viewer

Comparison 1. Prevention trials

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Insoles vs placebo/No intervention Show forest plot	3	1688	Risk Ratio (M‐H, Random, 95% CI)	0.73 [0.43, 1.22]
Open in figure viewer Analysis 1.1 Comparison 1 Prevention trials, Outcome 1 Insoles vs placebo/No intervention.

Open in table viewer

Comparison 2. Prevention trials ‐ ITT Assuming all dropouts did not have back pain

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Insoles vs placebo/No intervention Show forest plot	3	2061	Risk Ratio (M‐H, Random, 95% CI)	0.74 [0.43, 1.27]
Open in figure viewer Analysis 2.1 Comparison 2 Prevention trials ‐ ITT Assuming all dropouts did not have back pain, Outcome 1 Insoles vs placebo/No intervention.

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Comparison 3. Prevention trials ‐ ITT Assuming dropouts were similar to controls

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Insoles vs placebo/No intervention Show forest plot	3	2061	Risk Ratio (M‐H, Random, 95% CI)	0.85 [0.58, 1.23]
Open in figure viewer Analysis 3.1 Comparison 3 Prevention trials ‐ ITT Assuming dropouts were similar to controls, Outcome 1 Insoles vs placebo/No intervention.

Open in table viewer

Comparison 4. Prevention trials ‐ High quality

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Insoles vs placebo/No intervention Show forest plot	2	300	Risk Ratio (M‐H, Random, 95% CI)	0.79 [0.46, 1.39]
Open in figure viewer Analysis 4.1 Comparison 4 Prevention trials ‐ High quality, Outcome 1 Insoles vs placebo/No intervention.

Open in table viewer

Comparison 5. Prevention trials ‐ High quality ‐ ITT Assuming all dropout did not have back pain

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Insoles vs placebo/No intervention Show forest plot	2	550	Risk Ratio (M‐H, Random, 95% CI)	0.81 [0.46, 1.45]
Open in figure viewer Analysis 5.1 Comparison 5 Prevention trials ‐ High quality ‐ ITT Assuming all dropout did not have back pain, Outcome 1 Insoles vs placebo/No intervention.

Open in table viewer

Comparison 6. Prevention trials ‐ High Quality ‐ ITT Assuming dropouts were similar to controls

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Insoles vs placebo/No intervention Show forest plot	2	550	Risk Ratio (M‐H, Random, 95% CI)	0.90 [0.61, 1.32]
Open in figure viewer Analysis 6.1 Comparison 6 Prevention trials ‐ High Quality ‐ ITT Assuming dropouts were similar to controls, Outcome 1 Insoles vs placebo/No intervention.

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Comparison 7. Prevention trials ‐ Customized insoles

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Insoles vs placebo/No intervention Show forest plot	2	249	Risk Ratio (M‐H, Random, 95% CI)	0.74 [0.34, 1.61]
Open in figure viewer Analysis 7.1 Comparison 7 Prevention trials ‐ Customized insoles, Outcome 1 Insoles vs placebo/No intervention.

Open in table viewer

Comparison 8. Prevention trials ‐ Customized insoles ‐ ITT Assuming all dropout did not have back pain

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Insoles vs placebo/No intervention Show forest plot	2	414	Risk Ratio (M‐H, Random, 95% CI)	0.81 [0.43, 1.52]
Open in figure viewer Analysis 8.1 Comparison 8 Prevention trials ‐ Customized insoles ‐ ITT Assuming all dropout did not have back pain, Outcome 1 Insoles vs placebo/No intervention.

Open in table viewer

Comparison 9. Prevention trials ‐ Customized insoles‐ ITT Assuming dropouts were similar to controls

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Insoles vs placebo/No intervention Show forest plot	2	414	Risk Ratio (M‐H, Random, 95% CI)	0.83 [0.53, 1.31]
Open in figure viewer Analysis 9.1 Comparison 9 Prevention trials ‐ Customized insoles‐ ITT Assuming dropouts were similar to controls, Outcome 1 Insoles vs placebo/No intervention.

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Comparison 10. Prevention trials ‐ Non customized insoles

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Insoles vs placebo/No intervention Show forest plot	2	1492	Risk Ratio (M‐H, Random, 95% CI)	0.69 [0.33, 1.43]
Open in figure viewer Analysis 10.1 Comparison 10 Prevention trials ‐ Non customized insoles, Outcome 1 Insoles vs placebo/No intervention.

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Comparison 11. Prevention trials ‐ Not Customized insoles‐ ITT Assuming all dropout did not have back pain

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Insoles vs placebo/No intervention Show forest plot	2	1782	Risk Ratio (M‐H, Random, 95% CI)	0.66 [0.31, 1.42]
Open in figure viewer Analysis 11.1 Comparison 11 Prevention trials ‐ Not Customized insoles‐ ITT Assuming all dropout did not have back pain, Outcome 1 Insoles vs placebo/No intervention.

Open in table viewer

Comparison 12. Prevention trials ‐ Not Customized insoles‐ ITT Assuming dropouts were similar to controls

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Insoles vs placebo/No intervention Show forest plot	2	1782	Risk Ratio (M‐H, Random, 95% CI)	0.78 [0.37, 1.65]
Open in figure viewer Analysis 12.1 Comparison 12 Prevention trials ‐ Not Customized insoles‐ ITT Assuming dropouts were similar to controls, Outcome 1 Insoles vs placebo/No intervention.

Figure 1

Summary of risks of bias

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Analysis 1.1

Comparison 1 Prevention trials, Outcome 1 Insoles vs placebo/No intervention.

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Analysis 2.1

Comparison 2 Prevention trials ‐ ITT Assuming all dropouts did not have back pain, Outcome 1 Insoles vs placebo/No intervention.

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Analysis 3.1

Comparison 3 Prevention trials ‐ ITT Assuming dropouts were similar to controls, Outcome 1 Insoles vs placebo/No intervention.

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Analysis 4.1

Comparison 4 Prevention trials ‐ High quality, Outcome 1 Insoles vs placebo/No intervention.

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Analysis 5.1

Comparison 5 Prevention trials ‐ High quality ‐ ITT Assuming all dropout did not have back pain, Outcome 1 Insoles vs placebo/No intervention.

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Analysis 6.1

Comparison 6 Prevention trials ‐ High Quality ‐ ITT Assuming dropouts were similar to controls, Outcome 1 Insoles vs placebo/No intervention.

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Analysis 7.1

Comparison 7 Prevention trials ‐ Customized insoles, Outcome 1 Insoles vs placebo/No intervention.

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Analysis 8.1

Comparison 8 Prevention trials ‐ Customized insoles ‐ ITT Assuming all dropout did not have back pain, Outcome 1 Insoles vs placebo/No intervention.

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Analysis 9.1

Comparison 9 Prevention trials ‐ Customized insoles‐ ITT Assuming dropouts were similar to controls, Outcome 1 Insoles vs placebo/No intervention.

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Analysis 10.1

Comparison 10 Prevention trials ‐ Non customized insoles, Outcome 1 Insoles vs placebo/No intervention.

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Analysis 11.1

Comparison 11 Prevention trials ‐ Not Customized insoles‐ ITT Assuming all dropout did not have back pain, Outcome 1 Insoles vs placebo/No intervention.

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Analysis 12.1

Comparison 12 Prevention trials ‐ Not Customized insoles‐ ITT Assuming dropouts were similar to controls, Outcome 1 Insoles vs placebo/No intervention.

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Comparison 1. Prevention trials

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Insoles vs placebo/No intervention Show forest plot	3	1688	Risk Ratio (M‐H, Random, 95% CI)	0.73 [0.43, 1.22]

Comparison 1. Prevention trials

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Comparison 2. Prevention trials ‐ ITT Assuming all dropouts did not have back pain

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Insoles vs placebo/No intervention Show forest plot	3	2061	Risk Ratio (M‐H, Random, 95% CI)	0.74 [0.43, 1.27]

Comparison 2. Prevention trials ‐ ITT Assuming all dropouts did not have back pain

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Comparison 3. Prevention trials ‐ ITT Assuming dropouts were similar to controls

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Insoles vs placebo/No intervention Show forest plot	3	2061	Risk Ratio (M‐H, Random, 95% CI)	0.85 [0.58, 1.23]

Comparison 3. Prevention trials ‐ ITT Assuming dropouts were similar to controls

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Comparison 4. Prevention trials ‐ High quality

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Insoles vs placebo/No intervention Show forest plot	2	300	Risk Ratio (M‐H, Random, 95% CI)	0.79 [0.46, 1.39]

Comparison 4. Prevention trials ‐ High quality

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Comparison 5. Prevention trials ‐ High quality ‐ ITT Assuming all dropout did not have back pain

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Insoles vs placebo/No intervention Show forest plot	2	550	Risk Ratio (M‐H, Random, 95% CI)	0.81 [0.46, 1.45]

Comparison 5. Prevention trials ‐ High quality ‐ ITT Assuming all dropout did not have back pain

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Comparison 6. Prevention trials ‐ High Quality ‐ ITT Assuming dropouts were similar to controls

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Insoles vs placebo/No intervention Show forest plot	2	550	Risk Ratio (M‐H, Random, 95% CI)	0.90 [0.61, 1.32]

Comparison 6. Prevention trials ‐ High Quality ‐ ITT Assuming dropouts were similar to controls

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Comparison 7. Prevention trials ‐ Customized insoles

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Insoles vs placebo/No intervention Show forest plot	2	249	Risk Ratio (M‐H, Random, 95% CI)	0.74 [0.34, 1.61]

Comparison 7. Prevention trials ‐ Customized insoles

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Comparison 8. Prevention trials ‐ Customized insoles ‐ ITT Assuming all dropout did not have back pain

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Insoles vs placebo/No intervention Show forest plot	2	414	Risk Ratio (M‐H, Random, 95% CI)	0.81 [0.43, 1.52]

Comparison 8. Prevention trials ‐ Customized insoles ‐ ITT Assuming all dropout did not have back pain

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Comparison 9. Prevention trials ‐ Customized insoles‐ ITT Assuming dropouts were similar to controls

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Insoles vs placebo/No intervention Show forest plot	2	414	Risk Ratio (M‐H, Random, 95% CI)	0.83 [0.53, 1.31]

Comparison 9. Prevention trials ‐ Customized insoles‐ ITT Assuming dropouts were similar to controls

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Comparison 10. Prevention trials ‐ Non customized insoles

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Insoles vs placebo/No intervention Show forest plot	2	1492	Risk Ratio (M‐H, Random, 95% CI)	0.69 [0.33, 1.43]

Comparison 10. Prevention trials ‐ Non customized insoles

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Comparison 11. Prevention trials ‐ Not Customized insoles‐ ITT Assuming all dropout did not have back pain

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Insoles vs placebo/No intervention Show forest plot	2	1782	Risk Ratio (M‐H, Random, 95% CI)	0.66 [0.31, 1.42]

Comparison 11. Prevention trials ‐ Not Customized insoles‐ ITT Assuming all dropout did not have back pain

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Comparison 12. Prevention trials ‐ Not Customized insoles‐ ITT Assuming dropouts were similar to controls

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Insoles vs placebo/No intervention Show forest plot	2	1782	Risk Ratio (M‐H, Random, 95% CI)	0.78 [0.37, 1.65]

Comparison 12. Prevention trials ‐ Not Customized insoles‐ ITT Assuming dropouts were similar to controls

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Referencias

References to studies included in this review

Basford 1988 {published data only}

Larsen 2002 {published and unpublished data}

Milgrom 2005 {published data only}

Schwellnus 1990 {published data only}

Shabat 2005 {published data only}

Tooms 1987 {published and unpublished data}

References to studies excluded from this review

Dananberg 1999 {published data only}

Sobel 2001 {published and unpublished data}

Wosk 1985 {published data only}

Additional references

Alderson 2003

Andersson 2004

Ball 2002

Bird 1999

Boer 1998

Brady 2003

Farrar 2001

Loney 1999

Oxman 1993

Robinson 2002

Shekelle 1994

Sibbald 1998

VA 1999

van Tulder 2003

Waddell 1996

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Characteristics of excluded studies [ordered by study ID]

Data and analyses

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Instituciones a las que se accedió previamente

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