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Meta-Analysis
. 2015 Mar 16;2015(3):CD004020.
doi: 10.1002/14651858.CD004020.pub3.

Braces and orthoses for treating osteoarthritis of the knee

Tijs Duivenvoorden  1 , Reinoud W Brouwer, Tom M van Raaij, Arianne P Verhagen, Jan A N Verhaar, Sita M A Bierma-Zeinstra
Affiliations
Meta-Analysis

Braces and orthoses for treating osteoarthritis of the knee

Tijs Duivenvoorden et al. Cochrane Database Syst Rev. .

Abstract

Background: Individuals with osteoarthritis (OA) of the knee can be treated with a knee brace or a foot/ankle orthosis. The main purpose of these aids is to reduce pain, improve physical function and, possibly, slow disease progression. This is the second update of the original review published in Issue 1, 2005, and first updated in 2007.

Objectives: To assess the benefits and harms of braces and foot/ankle orthoses in the treatment of patients with OA of the knee.

Search methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and EMBASE (current contents, HealthSTAR) up to March 2014. We screened reference lists of identified trials and clinical trial registers for ongoing studies.

Selection criteria: Randomised and controlled clinical trials investigating all types of braces and foot/ankle orthoses for OA of the knee compared with an active control or no treatment.

Data collection and analysis: Two review authors independently selected trials and extracted data. We assessed risk of bias using the 'Risk of bias' tool of The Cochrane Collaboration. We analysed the quality of the results by performing an overall grading of evidence by outcome using the GRADE (Grades of Recommendation, Assessment, Development and Evaluation) approach. As a result of heterogeneity of studies, pooling of outcome data was possible for only three insole studies.

Main results: We included 13 studies (n = 1356): four studies in the first version, three studies in the first update and six additional studies (n = 529 participants) in the second update. We included studies that reported results when study participants with early to severe knee OA (Kellgren & Lawrence grade I-IV) were treated with a knee brace (valgus knee brace, neutral brace or neoprene sleeve) or an orthosis (laterally or medially wedged insole, neutral insole, variable or constant stiffness shoe) or were given no treatment. The main comparisons included (1) brace versus no treatment; (2) foot/ankle orthosis versus no treatment or other treatment; and (3) brace versus foot/ankle orthosis. Seven studies had low risk, two studies had high risk and four studies had unclear risk of selection bias. Five studies had low risk, three studies had high risk and five studies had unclear risk of detection bias. Ten studies had high risk and three studies had low risk of performance bias. Nine studies had low risk and four studies had high risk of reporting bias.Four studies compared brace versus no treatment, but only one provided useful data for meta-analysis at 12-month follow-up. One study (n = 117, low-quality evidence) showed lack of evidence of an effect on visual analogue scale (VAS) pain scores (absolute percent change 0%, mean difference (MD) 0.0, 95% confidence interval (CI) -0.84 to 0.84), function scores (absolute percent change 1%, MD 1.0, 95% CI -2.98 to 4.98) and health-related quality of life scores (absolute percent change 4%, MD -0.04, 95% CI -0.12 to 0.04) after 12 months. Many participants stopped their initial treatment because of lack of effect (24 of 60 participants in the brace group and 14 of 57 participants in the no treatment group; absolute percent change 15%, risk ratio (RR) 1.63, 95% CI 0.94 to 2.82). The other studies reported some improvement in pain, function and health-related quality of life (P value ≤ 0.001). Stiffness and treatment failure (need for surgery) were not reported in the included studies.For the comparison of laterally wedged insole versus no insole, one study (n = 40, low-quality evidence) showed a lower VAS pain score in the laterally wedged insole group (absolute percent change 16%, MD -1.60, 95% CI -2.31 to -0.89) after nine months. Function, stiffness, health-related quality of life, treatment failure and adverse events were not reported in the included study.For the comparison of laterally wedged versus neutral insole after pooling of three studies (n = 358, moderate-quality evidence), little evidence was found of an effect on numerical rating scale (NRS) pain scores (absolute percent change 1.0%, MD 0.1, 95% CI -0.45 to 0.65), Western Ontario-McMaster Osteoarthritis Scale (WOMAC) stiffness scores (absolute percent change 0.1%, MD 0.07, 95% CI -4.96 to 5.1) and WOMAC function scores (absolute percent change 0.9%, MD 0.94, 95% CI - 2.98 to 4.87) after 12 months. Evidence of an effect on health-related quality of life scores (absolute percent change 1.0%, MD 0.01, 95% CI -0.05 to 0.03) was lacking in one study (n = 179, moderate-quality evidence). Treatment failure and adverse events were not studied for this comparison in the included studies.Data for the comparison of laterally wedged insole versus valgus knee brace could not be pooled. After six months' follow-up, no statistically significant difference was noted in VAS pain scores (absolute percent change -2.0%, MD -0.2, 95% CI -1.15 to 0.75) and WOMAC function scores (absolute percent change 0.1%, MD 0.1, 95% CI -7.26 to 0.75) in one study (n = 91, low-quality evidence); however both groups showed improvement. Stiffness, health-related quality of life, treatment failure and adverse events were not reported in the included studies for this comparison.

Authors' conclusions: Evidence was inconclusive for the benefits of bracing for pain, stiffness, function and quality of life in the treatment of patients with medial compartment knee OA. On the basis of one laterally wedged insole versus no treatment study, we conclude that evidence of an effect on pain in patients with varus knee OA is lacking. Moderate-quality evidence shows lack of an effect on improvement in pain, stiffness and function between patients treated with a laterally wedged insole and those treated with a neutral insole. Low-quality evidence shows lack of an effect on improvement in pain, stiffness and function between patients treated with a valgus knee brace and those treated with a laterally wedged insole. The optimal choice for an orthosis remains unclear, and long-term implications are lacking.

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Conflict of interest statement

Conflict of interest is possible because two included studies (Brouwer 2006; Raaij van 2010) were conducted by four of the authors (RB, TR, SB, JV) of this systematic review.

Figures

1
1
Figure 1 Flow diagram of the study according to the PRISMA statement.
2
2
Figure 2 Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
1.1
1.1. Analysis
Comparison 1 Brace versus no treatment, Outcome 1 Pain (VAS).
1.2
1.2. Analysis
Comparison 1 Brace versus no treatment, Outcome 2 Knee function (HSS).
1.3
1.3. Analysis
Comparison 1 Brace versus no treatment, Outcome 3 Walking distance (km).
1.4
1.4. Analysis
Comparison 1 Brace versus no treatment, Outcome 4 Quality of life (EQ‐5D).
1.5
1.5. Analysis
Comparison 1 Brace versus no treatment, Outcome 5 Total adverse events.
2.1
2.1. Analysis
Comparison 2 Brace versus lateral wedge insole, Outcome 1 Walking distance.
2.2
2.2. Analysis
Comparison 2 Brace versus lateral wedge insole, Outcome 2 WOMAC 6 months.
2.3
2.3. Analysis
Comparison 2 Brace versus lateral wedge insole, Outcome 3 Pain (VAS).
3.1
3.1. Analysis
Comparison 3 Lateral wedge insole versus no insole, Outcome 1 Pain (VAS).
3.2
3.2. Analysis
Comparison 3 Lateral wedge insole versus no insole, Outcome 2 Walking distance (km).
4.1
4.1. Analysis
Comparison 4 Lateral wedge insole versus neutral insole, Outcome 1 Pain (NRS).
4.2
4.2. Analysis
Comparison 4 Lateral wedge insole versus neutral insole, Outcome 2 Pain (WOMAC).
4.3
4.3. Analysis
Comparison 4 Lateral wedge insole versus neutral insole, Outcome 3 Stiffness (WOMAC).
4.4
4.4. Analysis
Comparison 4 Lateral wedge insole versus neutral insole, Outcome 4 Physical function (WOMAC).
4.5
4.5. Analysis
Comparison 4 Lateral wedge insole versus neutral insole, Outcome 5 Health‐related quality of life.
4.6
4.6. Analysis
Comparison 4 Lateral wedge insole versus neutral insole, Outcome 6 Physical activity scale for the elderly.
4.7
4.7. Analysis
Comparison 4 Lateral wedge insole versus neutral insole, Outcome 7 Number of steps taken per day.
4.8
4.8. Analysis
Comparison 4 Lateral wedge insole versus neutral insole, Outcome 8 Global patient assessment at 24 months.
4.9
4.9. Analysis
Comparison 4 Lateral wedge insole versus neutral insole, Outcome 9 Compliance at 6 months.
4.10
4.10. Analysis
Comparison 4 Lateral wedge insole versus neutral insole, Outcome 10 Time for negotiation of stairs.
4.11
4.11. Analysis
Comparison 4 Lateral wedge insole versus neutral insole, Outcome 11 6‐Minute walk distance.
5.1
5.1. Analysis
Comparison 5 Subtalar strapped insole versus inserted lateral wedge insole, Outcome 1 Pain (VAS).
5.2
5.2. Analysis
Comparison 5 Subtalar strapped insole versus inserted lateral wedge insole, Outcome 2 Lequesne index.
5.3
5.3. Analysis
Comparison 5 Subtalar strapped insole versus inserted lateral wedge insole, Outcome 3 FTA ‐ angle.
5.4
5.4. Analysis
Comparison 5 Subtalar strapped insole versus inserted lateral wedge insole, Outcome 4 Side effects at 8 weeks.
6.1
6.1. Analysis
Comparison 6 Subtalar strapped insole versus sock‐type insole, Outcome 1 FTA angle.
6.2
6.2. Analysis
Comparison 6 Subtalar strapped insole versus sock‐type insole, Outcome 2 Aggregate score.
7.1
7.1. Analysis
Comparison 7 Medial wedge insole versus neutral insole, Outcome 1 VAS rest.
7.2
7.2. Analysis
Comparison 7 Medial wedge insole versus neutral insole, Outcome 2 VAS movement.
7.3
7.3. Analysis
Comparison 7 Medial wedge insole versus neutral insole, Outcome 3 VAS night.
7.4
7.4. Analysis
Comparison 7 Medial wedge insole versus neutral insole, Outcome 4 WOMAC.
7.5
7.5. Analysis
Comparison 7 Medial wedge insole versus neutral insole, Outcome 5 Lequesne.
8.1
8.1. Analysis
Comparison 8 Variable stiffness shoe versus constant stiffness shoe, Outcome 1 Pain (WOMAC).
8.2
8.2. Analysis
Comparison 8 Variable stiffness shoe versus constant stiffness shoe, Outcome 2 Stiffness (WOMAC).
8.3
8.3. Analysis
Comparison 8 Variable stiffness shoe versus constant stiffness shoe, Outcome 3 Physical function (WOMAC).
See this image and copyright information in PMC

Update of

References

References to studies included in this review

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References to studies excluded from this review

Baker 2007 {published data only}
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Birmingham 2001 {published data only}
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Horlick 1993 {published data only}
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Hunter 2012 {published data only}
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References to other published versions of this review

2005 Initial review
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