title: 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.
abstract: BACKGROUND
  Efforts 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.
  
  
  METHODS
  Throughout 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 6h/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.
  
  
  RESULTS
  Intervention 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.
  
  
  CONCLUSIONS
  The 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).
authors: Department of Physical Therapy, Speech, and Occupational Therapy, School of Medicine, University of São Paulo, Brazil.
authors: Francis
authors: F
authors: Trombini-Souza
authors: Department of Physical Therapy, Speech, and Occupational Therapy, School of Medicine, University of São Paulo, Brazil.
authors: Alessandra B
authors: AB
authors: Matias
authors: Department of Physical Therapy, Speech, and Occupational Therapy, School of Medicine, University of São Paulo, Brazil.
authors: Mariane
authors: M
authors: Yokota
authors: Department of Physical Therapy, Speech, and Occupational Therapy, School of Medicine, University of São Paulo, Brazil.
authors: Marco K
authors: MK
authors: Butugan
authors: Rheumatology Division, School of Medicine, University of São Paulo, Brazil.
authors: Claudia
authors: C
authors: Goldenstein-Schainberg
authors: Rheumatology Division, School of Medicine, University of São Paulo, Brazil.
authors: Ricardo
authors: R
authors: Fuller
authors: Department of Physical Therapy, Speech, and Occupational Therapy, School of Medicine, University of São Paulo, Brazil. Electronic address: icnsacco@usp.br.
authors: Isabel C N
authors: IC
authors: Sacco
mesh_terms: D000082:Acetaminophen / Q000627:therapeutic use; D000368:Aged; D000369:Aged, 80 and over; D018712:Analgesics, Non-Narcotic / Q000627:therapeutic use; D000704:Analysis of Variance; D004185:Disability Evaluation; D005260:Female; D006801:Humans; D007719:Knee Joint / Q000503:physiopathology*; D008875:Middle Aged; D020370:Osteoarthritis, Knee / Q000503:physiopathology / Q000534:rehabilitation*; D010146:Pain / Q000209:etiology / Q000503:physiopathology* / Q000517:prevention & control; D011446:Prospective Studies; D012775:Shoes; D016138:Walking / Q000502:physiology; D016474:Weight-Bearing / Q000502:physiology*
chemical_list: D018712:Analgesics, Non-Narcotic; D000082:Acetaminophen
keywords: Biomechanics; Elderly; Gait; Knee osteoarthritis; Randomized controlled clinical trial; Shoes; Women