Pulsed electromagnetic fields for the management of knee osteoarthritis: multicentre, randomised, controlled, non-inferiority trial protocol

Abstract

IntroductionPulsed electromagnetic field (PEMF) is an available treatment for knee osteoarthritis (KOA), which is the most common cause of pain and disability. Nonetheless, whether the clinical effects are like that of most used drugs is unclear. Thus, this study aims to determine the effect of PEMF on pain relief by comparing them with the positive drug (celecoxib). Furthermore, this clinical trial aims to evaluate the effect of PEMF on function and quality of life with a long-term follow-up.Methods and analysisThis two-armed, non-inferiority, randomised, controlled trial will be conducted in the outpatient physiatry/physiotherapy clinic or inpatient ward of 17 hospitals in China. A total of 428 individuals will be included who are more than 40 years of age with diagnosed KOA. The participants will be randomly allocated to the PEMF group: receiving a 6-week PEMF (15 Hz, 30 mT) at a frequency of 40 min per day, 5 days per week plus sham drug (n=214), or drug group: receiving a 6-week celecoxib 200 mg combined with sham PEMF (n=214). Clinical outcomes will be measured at baseline (T0), mid-term of intervention (T1), post-intervention (T2), 10, 18 and 30 weeks (T3–5) of follow-up after randomisation. The primary outcome will be the Western Ontario and McMaster Universities (WOMAC) pain index. The secondary outcomes will be WOMAC function and stiffness, pain measured by numerical rating score, quality of life, 6-minute walk test, pain catastrophising scale and responder index.Ethics and disseminationThe trial is performed following the Declaration of Helsinki. The study protocol and consent form have been approved by the Ethics Committee on Biomedical Research of West China Hospital of Sichuan University (#2021-220). All patients will give informed consent before participation and the trial is initiated after approval. Results of this trial will be disseminated through publication in peer-reviewed journals.Trial registration numberChiCTR2100052131.

Current Evidence Using Pulsed Electromagnetic Fields in Osteoarthritis: A Systematic Review

“…This variability underscores efforts to explore the impact of PEMFs on different cohorts, ensuring a comprehensive understanding of its effectiveness. Larger studies, such as that conducted by Xiang et al [30], including 428 participants, contributed considerable statistical power to assessing the non-inferiority of PEMFs compared to, for example, COXIB therapy in managing knee osteoarthritis.…”

“…The diverse range of patient enrollment, with sample sizes ranging from 22 to 428 individuals, reflects efforts to explore PEMFs' impact across different cohorts. Larger trials, such as that by Xiang et al, including 428 participants, contribute substantial statistical power to assessing the non-inferiority of PEMFs compared to COXIB medication in managing knee osteoarthritis [30] [Table 2]. The consistent focus on the knee joint as the primary anatomical district affected by osteoarthritis aligns with the prevalence of studies in knee-related outcomes, although valuable investigations extend to other areas such as the lumbar spine and the cervical spine.…”