Long-term use of minimal footwear on pain, self-reported function, analgesic intake, and joint loading in elderly women with knee osteoarthritis: A randomized controlled trial

• The long-tem use of this low-cost minimalist footwear reduced the knee pain.
• This footwear improved the self-reported function for activities of daily living.
• Analgesic intake was lower in the intervention group.
• The knee joint loading was reduced while wearing the Moleca® footwear.
• This footwear can be considered as an alternative for knee osteoarthritis treatment.

BackgroundEfforts have been made to retard the progressive debilitating pain and joint dysfunction in patients with knee osteoarthritis. We aimed to evaluate the therapeutic effect of a low-cost minimalist footwear on pain, function, clinical and gait-biomechanical aspects of elderly women with knee osteoarthritis.MethodsThroughout a randomized, parallel and controlled clinical trial, fifty-six patients with medial knee osteoarthritis were randomly allocated to an intervention (n = 28) or control group (n = 28), and assessed at baseline and after three and six months. The intervention involved wearing Moleca® footwear for at least 6 h/day, 7 days/week, over 6 months. The pain subscale of the Western Ontario and McMaster Universities Osteoarthritis Index was the primary outcome. The secondary outcomes were the other subscales, Lequesne score, distance walked in 6 min, knee oedema and effusion, knee adduction moment and paracetamol intake. Intention-to-treat analysis was performed using two-way casewise ANOVA (< .05) and Cohen's d coefficient.FindingsIntervention group showed improvement in pain (effect size: 1.41, p < .001), function (effect size: 1.22, p = .001), stiffness (effect size: 0.76, p = .001), Lequesne score (effect size: 1.07, p < .001), and reduction by 21.8% in the knee adduction moment impulse (p = .017) during gait wearing Moleca®. The analgesic intake was lower in the intervention group.InterpretationThe long-term use of Moleca® footwear relieves pain, improves self-reported function, reduces the knee loading while wearing Moleca®, refrains the increase of analgesic intake in elderly women with knee osteoarthritis and can be considered as a conservative mechanical treatment option. ClinicalTrials.gov (NCT01342458)