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Study flow diagram
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Figure 1

Study flow diagram

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Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies
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Figure 2

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies

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Risk of bias summary: review authors' judgements about each risk of bias item for each included study
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Figure 3

Risk of bias summary: review authors' judgements about each risk of bias item for each included study

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Forest plot 1.1. Comparison: knee orthosis and exercises versus exercises alone. Outcome: pain during activity (0 to 10; higher score means worse pain)
Figuras y tablas -
Figure 4

Forest plot 1.1. Comparison: knee orthosis and exercises versus exercises alone. Outcome: pain during activity (0 to 10; higher score means worse pain)

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Comparison 1 Knee orthosis and non‐operative intervention (exercises) versus non‐operative intervention (exercises) alone, Outcome 1 Pain during activity (0 to 10; higher score means worse pain).
Figuras y tablas -
Analysis 1.1

Comparison 1 Knee orthosis and non‐operative intervention (exercises) versus non‐operative intervention (exercises) alone, Outcome 1 Pain during activity (0 to 10; higher score means worse pain).

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Comparison 1 Knee orthosis and non‐operative intervention (exercises) versus non‐operative intervention (exercises) alone, Outcome 2 Pain scores (0 to 10; higher score means worse pain).
Figuras y tablas -
Analysis 1.2

Comparison 1 Knee orthosis and non‐operative intervention (exercises) versus non‐operative intervention (exercises) alone, Outcome 2 Pain scores (0 to 10; higher score means worse pain).

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Comparison 1 Knee orthosis and non‐operative intervention (exercises) versus non‐operative intervention (exercises) alone, Outcome 3 Different pain scores (0 to 10; higher score means worse pain) at 12 weeks.
Figuras y tablas -
Analysis 1.3

Comparison 1 Knee orthosis and non‐operative intervention (exercises) versus non‐operative intervention (exercises) alone, Outcome 3 Different pain scores (0 to 10; higher score means worse pain) at 12 weeks.

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Comparison 1 Knee orthosis and non‐operative intervention (exercises) versus non‐operative intervention (exercises) alone, Outcome 4 Excellent or good results in terms of reduction in symptoms.
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Analysis 1.4

Comparison 1 Knee orthosis and non‐operative intervention (exercises) versus non‐operative intervention (exercises) alone, Outcome 4 Excellent or good results in terms of reduction in symptoms.

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Comparison 1 Knee orthosis and non‐operative intervention (exercises) versus non‐operative intervention (exercises) alone, Outcome 5 Functional scores (higher score means higher function).
Figuras y tablas -
Analysis 1.5

Comparison 1 Knee orthosis and non‐operative intervention (exercises) versus non‐operative intervention (exercises) alone, Outcome 5 Functional scores (higher score means higher function).

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Comparison 1 Knee orthosis and non‐operative intervention (exercises) versus non‐operative intervention (exercises) alone, Outcome 6 Discontinuation of a basic military training programme.
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Analysis 1.6

Comparison 1 Knee orthosis and non‐operative intervention (exercises) versus non‐operative intervention (exercises) alone, Outcome 6 Discontinuation of a basic military training programme.

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Comparison 2 One type of orthosis versus another type, Outcome 1 Pain score (0 to 10: higher score means worse pain).
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Analysis 2.1

Comparison 2 One type of orthosis versus another type, Outcome 1 Pain score (0 to 10: higher score means worse pain).

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Comparison 2 One type of orthosis versus another type, Outcome 2 Functional score (0 to 53: higher scores means greater function).
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Analysis 2.2

Comparison 2 One type of orthosis versus another type, Outcome 2 Functional score (0 to 53: higher scores means greater function).

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Comparison 2 One type of orthosis versus another type, Outcome 3 Discontinuation of a basic military training programme.
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Analysis 2.3

Comparison 2 One type of orthosis versus another type, Outcome 3 Discontinuation of a basic military training programme.

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Comparison 2 One type of orthosis versus another type, Outcome 4 Complications.
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Analysis 2.4

Comparison 2 One type of orthosis versus another type, Outcome 4 Complications.

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Comparison 3 Orthosis versus exercise, Outcome 1 Pain during activity (0 to 10: higher score means worse pain).
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Analysis 3.1

Comparison 3 Orthosis versus exercise, Outcome 1 Pain during activity (0 to 10: higher score means worse pain).

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Comparison 3 Orthosis versus exercise, Outcome 2 Sensitivity analyses (knees): Pain during activity (0 to 10: higher score means worse pain).
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Analysis 3.2

Comparison 3 Orthosis versus exercise, Outcome 2 Sensitivity analyses (knees): Pain during activity (0 to 10: higher score means worse pain).

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Comparison 3 Orthosis versus exercise, Outcome 3 Functional scores (0 to 53: higher scores means greater function).
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Analysis 3.3

Comparison 3 Orthosis versus exercise, Outcome 3 Functional scores (0 to 53: higher scores means greater function).

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Summary of findings for the main comparison. Summary of findings: Knee orthosis (any type) and exercise versus control (exercise only) for treating patellofemoral pain syndrome

Knee orthosis and exercise versus exercise alone for patellofemoral pain syndrome (PFPS)

Patient or population: Adults (recruited from health clinics or military recruits) with PFPS (duration of symptoms ranged from acute, under 2 to 3 weeks in two trials, to predominantly chronic in three trials: mean durations 8.3 months, 21 months, 21 months)

Settings: Health clinics, home and military training establishments

Intervention: Knee orthosis (various types: knee sleeve, knee brace or patellar strap) and exercise (military training, home exercise programme)

Comparison: Exercise alone

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Exercise alone

Knee orthosis and exercise

Pain score (VAS)

Scale from: 0 to 10 (higher scores mean worse pain)

Follow‐up: 3 to 12 weeks (short‐term)

The mean pain score for the exercise alone group ranged across the control groups from 2.7 to 3.2 points; the mean change score from ‐0.47 to ‐0.96 points

The mean pain score in the knee orthosis and exercise group was 0.46 points lower (1.16 lower to 0.24 higher)

MD ‐0.46 (‐1.16 to 0.24)

234 (3)

⊕⊝⊝⊝
very low1

The MD and 95% CIs do not include clinically important treatment effects.

MCID: 30 mm on an 100 mm VAS (Lee 2003)

Functional outcomes

Scale various 2

Follow‐up:

6 and 12 weeks (short‐term)

The mean functional score in the knee orthosis and exercise group was 0.15 points lower (0.69 lower to 0.38 higher)

The mean difference in knee function (short‐term) in the knee orthosis group was 0.25 standard deviations lower (0.55 lower to 0.05 higher)

SMD ‐0.25 (‐0.55 to 0.05)

183 (2)

⊕⊝⊝⊝
very low3

Lower values equate to higher disability.

The SMD result equates to a small difference at most and in absolute terms, the mean differences for each trial were small (e.g. 0.9 for a range 0 to 68) and not clinically important

Quality of Life and General Health Assessments

See comment

See comment

No study reported this outcome

Impact on sporting and occupational participation

See comment

See comment

51 (1)4

⊕⊝⊝⊝
very low 5

One trial reported that 2 out of 31 (6.5%) participants in the knee orthosis groups versus 0 of 20 (0%) in the control group withdrew from their military training programme.

Resource use

See comment

See comment

No study reported this outcome

Participant satisfaction

See comment

See comment

No study reported this outcome

Complications

Follow‐up: 14 weeks6

See comment

See comment

59 with 84 affected knees (1)

⊕⊝⊝⊝
very low 7

Trial reported 16 complications (skin abrasions or discomfort) for 44 knees (36%) of participants in the knee orthosis group.

*The basis for the assumed risk (e.g. the 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).
CI: Confidence Interval; MCID: Minimal Clinically Important Difference; MD: Mean Difference; RR: Risk Ratio; SMD: Standardised Mean Difference; VAS: Visual Analogue Scale

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
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.
Very low quality: We are very uncertain about the estimate.

1. The quality of the evidence was downgraded two levels for major study limitations resulting in very serious risk of bias (including selection bias (1 trial) and performance bias (all 3 trials)), and one level for indirectness (this reflects the clinical heterogeneity such as variation in the interventions and outcome measures and measurement, and the generally inadequate description of these). There was, however, no statistical heterogeneity in the pooled data.

2. One trial reported WOMAC functional scores (0 to 68; higher values mean worse function) at six weeks and the other the results of a modified version of the Knee Function Scale (0 to 53; higher values mean better function) at 12 weeks.

3. The quality of the evidence was downgraded two levels for major study limitations resulting in very serious risk of bias (including selection bias (1 trial) and performance bias (both trials)), and one level for imprecision (wide confidence intervals and limited data).

4. Data on resumption of sports activities were not split by treatment group in one trial (35 participants).

5. The quality of the evidence was downgraded two levels for major study limitations resulting in very serious risk of bias (including performance and detection biases), and one level for indirectness (abandonment of military training may be for other reasons than serious knee pain).

6. The single study recording this outcome did not record complications for all groups. The follow‐up for complications appeared be during use; i.e. the basic military training programme of 14 weeks..

7. The quality of the evidence was downgraded two levels for major study limitations resulting in very serious risk of bias (including performance and detection biases and serious unit of analyses issues relating to the inclusion of participants with anterior knee pain in both knees), and imprecision (incomplete data from one small trial).

Figuras y tablas -
Summary of findings for the main comparison. Summary of findings: Knee orthosis (any type) and exercise versus control (exercise only) for treating patellofemoral pain syndrome
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Comparison 1. Knee orthosis and non‐operative intervention (exercises) versus non‐operative intervention (exercises) alone

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Pain during activity (0 to 10; higher score means worse pain) Show forest plot

3

234

Mean Difference (IV, Fixed, 95% CI)

‐0.46 [‐1.16, 0.24]

1.1 Knee sleeve

3

162

Mean Difference (IV, Fixed, 95% CI)

‐0.48 [‐1.31, 0.35]

1.2 Patellar strap

1

23

Mean Difference (IV, Fixed, 95% CI)

‐1.09 [‐3.71, 1.53]

1.3 Knee brace

1

49

Mean Difference (IV, Fixed, 95% CI)

‐0.20 [‐1.68, 1.28]

2 Pain scores (0 to 10; higher score means worse pain) Show forest plot

3

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

2.1 Knee orthosis (any)

3

234

Mean Difference (IV, Fixed, 95% CI)

‐0.46 [‐1.16, 0.24]

2.2 Sensitivity analysis (knees). Knee orthosis (any)

3

276

Mean Difference (IV, Fixed, 95% CI)

‐0.41 [‐1.04, 0.23]

3 Different pain scores (0 to 10; higher score means worse pain) at 12 weeks Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

3.1 Pain during activity

1

97

Mean Difference (IV, Fixed, 95% CI)

‐0.15 [‐1.20, 0.90]

3.2 Sensitivity analysis (knees). Pain during activity

1

139

Mean Difference (IV, Fixed, 95% CI)

‐0.15 [‐1.02, 0.72]

3.3 Pain 1 hour after sporting activity

1

97

Mean Difference (IV, Fixed, 95% CI)

0.75 [‐0.19, 1.69]

3.4 Sensitivity analysis (knees). Pain 1 hour after sporting activity

1

139

Mean Difference (IV, Fixed, 95% CI)

0.75 [‐0.04, 1.53]

3.5 Pain after 30 minutes sitting with knees flexed

1

97

Mean Difference (IV, Fixed, 95% CI)

0.25 [‐0.82, 1.32]

3.6 Sensitivity analysis (knees). Pain after sitting with knees flexed

1

139

Mean Difference (IV, Fixed, 95% CI)

0.25 [‐0.64, 1.14]

4 Excellent or good results in terms of reduction in symptoms Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

4.1 At 12 weeks

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.2 At 12 months

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

5 Functional scores (higher score means higher function) Show forest plot

2

Std. Mean Difference (IV, Fixed, 95% CI)

Subtotals only

5.1 Knee orthosis (any)

2

183

Std. Mean Difference (IV, Fixed, 95% CI)

‐0.25 [‐0.55, 0.05]

5.2 Sensitivity analysis (knees): Knee orthosis (any)

2

225

Std. Mean Difference (IV, Fixed, 95% CI)

‐0.28 [‐0.55, ‐0.01]

6 Discontinuation of a basic military training programme Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected
Figuras y tablas -
Comparison 1. Knee orthosis and non‐operative intervention (exercises) versus non‐operative intervention (exercises) alone
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Comparison 2. One type of orthosis versus another type

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Pain score (0 to 10: higher score means worse pain) Show forest plot

2

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

1.1 Patellar strap versus knee sleeve

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.2 Knee brace versus knee sleeve

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.3 Knee brace versus knee sleeve (sensitivity analysis: knees)

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.4 Knee brace versus knee sleeve

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.5 Knee brace versus knee sleeve (sensitivity analysis: knees)

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

2 Functional score (0 to 53: higher scores means greater function) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

2.1 Knee brace versus knee sleeve

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.2 Knee brace versus knee sleeve (sensitivity analysis: knees)

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

3 Discontinuation of a basic military training programme Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

3.1 Patellar strap versus knee sleeve

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4 Complications Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

4.1 Knee sleeve and patella ring versus knee sleeve without patellar ring

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]
Figuras y tablas -
Comparison 2. One type of orthosis versus another type
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Comparison 3. Orthosis versus exercise

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Pain during activity (0 to 10: higher score means worse pain) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

1.1 Pain score during sporting activity

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.2 Pain score 1 hour after sporting activity

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.3 Pain score following 30 minutes of sitting with knees flexed

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

2 Sensitivity analyses (knees): Pain during activity (0 to 10: higher score means worse pain) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

2.1 Pain score during sporting activity

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.2 Pain score 1 hour after sporting activity

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.3 Pain score following 30 minutes of sitting with knees flexed

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

3 Functional scores (0 to 53: higher scores means greater function) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

3.1 Participants = denominators

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.2 Sensitivity analysis (knees)

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]
Figuras y tablas -
Comparison 3. Orthosis versus exercise
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