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The effects of knee brace, biomechanical footwear device, and exercise in knee osteoarthritis: a randomized clinical trial

In brief

Knee brace with exercise reduces pain by 48 mm after 4 months

In 136 adults with mild-to-moderate knee osteoarthritis, all three strategies-brace plus exercise, a biomechanical shoe, and exercise alone-lowered pain over a year. The brace-exercise combo achieved the biggest drop at four months (about 48 mm on a 100-mm scale) but the advantage faded by twelve months and was not clearly clinically meaningful. Further work is needed to confirm lasting benefits.

Journal
Annals of physical and rehabilitation medicine (Q1)
Published
18 September 2026
Study design
Randomized controlled trial
Evidence level
Level 1, High (CEBM 1b)
Authors
Heikki Kivistö, Jari Ylinen, Arja Häkkinen, Jari Arokoski, Joost Dekker, Konsta Pamilo, et al.
PMID
42759360
DOI
10.1016/j.rehab.2026.102170

Why clinicians should know about it

  • Picked for Family Practice (top studies of the week, 20 September 2026): Not directly relevant to primary care chronic disease management

Abstract

BACKGROUND: Knee osteoarthritis (OA) poses a significant economic and personal burden globally. OBJECTIVE: To investigate the effectiveness of clinical interventions for knee OA. METHODS: This randomized clinical trial was conducted at Central Finland Central Hospital. A total of 136 participants with mild-to-moderate knee OA participated in the intervention (60% women, mean age 61 years). The primary intervention lasted 4 months, with a 12-month follow-up. Participants were allocated to: (1) knee brace plus exercise, (2) biomechanical footwear device, or (3) exercise alone. The primary outcome was knee pain intensity measured using the Visual Analog Scale (VAS, 0-100 mm). Secondary outcomes included the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain, stiffness, and function subscales, and health-related quality of life assessed using the Short Form 36 Health Questionnaire (SF-36) physical and mental component scores. RESULTS: Knee pain decreased at both 4 and 12 months in all groups. Mean VAS reductions at 4 and 12 months were -48 and -38 mm in the knee brace plus exercise group, -32 and -28 mm in the footwear group, and -35 and -26 mm in the exercise group. A significant between-group difference favoring the knee brace plus exercise group was observed at 4 months (P = 0.009), but not at 12 months (P = 0.067). WOMAC pain scores also showed a between-group difference at 4 months (P = 0.042), favoring the knee brace plus exercise and footwear group over exercise alone, with no difference at 12 months. SF-36 physical component change scores favored the knee brace plus exercise and footwear groups at 12 months (P = 0.003), while no between-group difference was observed for the mental component. CONCLUSIONS: All interventions reduced knee pain. Knee brace combined with exercise showed greater short-term benefit, but the difference was not clinically significant. Findings should be interpreted cautiously, and further research is needed. This clinical trial is registered on ClinicalTrial.gov with ID NCT03684850.

Abstract as published, via PubMed.

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For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.