Development and evaluation of acu-magnetic therapeutic apparel for symptomatic knee osteoarthritis (KOA) relief in the elderly

Abstract

Knee osteoarthritis (KOA) is the most common form of arthritis that is highly prevalent in the general population, especially among elderly individuals. Although many treatments are available to relieve KOA symptoms, side effects, drug interactions, and medical risk produced in conventional treatments restrict their practical application on older adults with poor health condition. This study aims to develop a novel acu-magnetic therapeutic apparel as a nonpharmacological treatment applying acupuncture point stimulation via magnetic approach and to assess the corresponding effects on symptomatic KOA relief via a randomized controlled trial (RCT). This interdisciplinary research involves three principal parts including a literature review on KOA, acu-magnetic therapeutic knee brace development, and evaluation on therapeutic effects of the developed knee brace on the relief of symptomatic KOA in elderly individuals. The first part was to conduct the literature review on KOA qualitatively and quantitatively. The comprehensive knowledge on KOA pathology, symptoms, prevalence, associated risk factors and existing treatments, was reviewed qualitatively to address the urgent need for a new non-pharmacological approach and to distinguish acu-magnetic therapy as a promising treatment for elderly patients with symptomatic KOA. Additionally, previous RCTs on acu-therapy for KOA treatment were systematically reviewed, selected, and quantitatively analyzed through a meta-analysis to positively support the acu-magnetic apparel development for symptomatic KOA relief. Five acupuncture points were originally selected according to academic reviews for therapeutic apparel design. The mechanisms and characteristics of acu-therapeutic treatment were identified to provide background information for acu-magnetic apparel therapy administration in elderly individuals. The second part involved development of an acu-magnetic therapeutic apparel for symptomatic KOA relief in the elderly. An acu-magnetic therapeutic knee brace prototype was developed following wear trial evaluation to preliminarily investigate its acu-magnetic function in relieving symptomatic KOA in the elderly. Three experiments, namely, magnet strength, fabric material, and fabric and magnet fitting tests, were designed to provide an objective evidence-based material selection and optimization for acu-magnetic therapeutic knee brace development. To increase subjective acceptance, this therapeutic knee brace was improved in terms of comfort, convenience, usability, and aesthetics according to the users' feedbacks and finalized using identified materials. The therapeutic effectiveness of the developed acu-magnetic knee brace in relieving symptomatic KOA in the elderly was evaluated in the third part of this research. A three-arm blinded RCT was performed after a pilot study to evaluate the effectiveness and feasibility of the developed knee brace for symptomatic KOA relief in terms of knee stiffness, knee pain, physical function, balance ability, and knee flexion range of motion. A total of 106 subjects aged 60-80 years old participated in RCT study and were randomly allocated to an experimental group, a sham group and a control group to compare the therapeutic effectiveness of the knee brace intervention for 6 weeks. The outcomes of the RCT demonstrated the effects of the developed acu-magnetic knee brace on the improvements in knee stiffness, knee pain, physical function, and balance ability, as well as knee range of motion in elderly individuals with symptomatic KOA.