Dataset Information

A comparison between laterally wedged insoles and ankle-foot orthoses for the treatment of medial osteoarthritis of the knee: A randomized cross-over trial.

ABSTRACT:

Objective

To compare biomechanical and clinical outcome of laterally wedged insoles (LWI) and an ankle-foot orthosis (AFO) in patients with medial knee osteoarthritis.

Design

Single-centre, block-randomized, cross-over controlled trial.

Setting

Outpatient clinic.

Subjects

About 39 patients with symptomatic medial knee osteoarthritis.

Interventions

Patients started with either LWI or AFO, determined randomly, and six weeks later changed to the alternative.

Main measures

Change in the 1st maximum of external knee adduction moment (eKAM) was assessed with gait analysis. Additional outcomes were other kinetic and kinematic changes and the patient-reported outcomes EQ-5D-5L, Oxford Knee Score (OKS), American Knee Society Clinical Rating System (AKSS), Hannover Functional Ability Questionnaire - Osteoarthritis and knee pain.

Results

Mean age (SD) of the study population was 58 (8) years, mean BMI 30 (5). Both aids significantly improved OKS (LWI P = 0.003, AFO P = 0.001), AKSS Knee Score (LWI P = 0.01, AFO P = 0.004) and EQ-5D-5L Index (LWI P = 0.001, AFO P = 0.002). AFO reduced the 1st maximum of eKAM by 18% (P < 0.001). The LWI reduced both maxima by 6% (P = 0.02, P = 0.03). Both AFO and LWI reduced the knee adduction angular impulse (KAAI) by 11% (P < 0.001) and 5% (P = 0.05) respectively. The eKAM (1st maximum) and KAAI reduction was significantly larger with AFO than with LWI (P = 0.001, P = 0.004).

Conclusions

AFO reduces medial knee load more than LWI. Nevertheless, no clinical superiority of either of the two aids could be shown.

SUBMITTER: Schwarze M

PROVIDER: S-EPMC8193604 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ImportanceThere is no consensus regarding the efficacy of lateral wedge insoles as a treatment for pain in medial knee osteoarthritis.ObjectiveTo evaluate whether lateral wedge insoles reduce pain in patients with medial knee osteoarthritis compared with an appropriate control.Data sourcesDatabases searched include the Cochrane Central Register of Controlled Trials, EMBASE, AMED, MEDLINE, CINAHL Plus, ScienceDirect, SCOPUS, Web of Science, and BIOSIS from inception to May 2013, with no limits on study date or language. The metaRegister of Controlled Trials and the NHS Evidence website were also searched.Study selectionIncluded were randomized trials comparing shoe-based treatments (lateral heel wedge insoles or shoes with variable stiffness soles) aimed at reducing medial knee load, with a neutral or no wedge control condition in patients with painful medial knee osteoarthritis. Studies must have included patient-reported pain as an outcome.Data extraction and synthesisTrial data were extracted independently by 2 researchers using a standardized form. Risk of bias was assessed using the Cochrane Risk of Bias tool by 2 observers. Eligible studies were pooled using a random-effects approach.Main outcome and measuresChange in self-reported knee pain at follow-up.ResultsTwelve trials met inclusion criteria with a total of 885 participants of whom 502 received lateral wedge treatment. The pooled standardized mean difference (SMD) suggested a favorable association with lateral wedges compared with control (SMD, -0.47; 95% CI, -0.80 to -0.14); however, substantial heterogeneity was present (I2 = 82.7%). This effect size represents an effect of -2.12 points on the 20-point Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain scale. Larger trials with a lower risk of bias suggested a null association. Meta-regression analyses showed that higher effect sizes (unstandardized β, 1.07 [95% CI, 0.28 to 1.87] for trials using a no treatment control) were seen in trials using a no wedge treatment control group (n = 4 trials; SMD, -1.20 [95% CI, -2.09 to -0.30]) and lower effect sizes (unstandardized β, 0.26 [95% CI, 0.002 to 0.52] for each bias category deemed low risk) when the study method was deemed at low risk of bias. Among trials in which the control treatment was a neutral insole (n = 7), lateral wedges showed no association (SMD, -0.03 [95% CI, -0.18 to 0.12] on WOMAC; this represents an effect of -0.12 points), and results showed little heterogeneity (I2 = 7.1%).Conclusions and relevanceAlthough meta-analytic pooling of all studies showed a statistically significant association between use of lateral wedges and lower pain in medial knee osteoarthritis, restriction of studies to those using a neutral insole comparator did not show a significant or clinically important association. These findings do not support the use of lateral wedges for this indication.