Chang Wei-Ju, Chiang Alan, Chowdhury Nahian, Adie Sam, Naylor Justine M, Finn Harrison, Rizzo Rodrigo R N, Gorgon Edward, O'Hagan Edel, Schabrun Siobhan M
School of Health Sciences, University of New South Wales Medicine & Health, Sydney, New South Wales, Australia
School of Health Sciences, The University of Newcastle, Newcastle, New South Wales, Australia.
BMJ Open. 2025 May 23;15(5):e097293. doi: 10.1136/bmjopen-2024-097293.
To examine the feasibility, safety and perceived patient response of a combined repetitive transcranial magnetic stimulation (rTMS) and quadriceps strengthening exercise intervention for knee osteoarthritis.
A two-arm, participant-blinded, therapist-blinded and assessor-blinded, randomised controlled trial with additional follow-up of pain and function at 3 months. Participants were randomised to receive active rTMS+exercise (AR+EX) or sham rTMS+exercise (SR+EX) twice weekly for 6 weeks while completing home exercises twice a week. Primary outcomes included recruitment rate, treatment attendance, dropouts, willingness to undergo therapy (11-point Numeric Rating Scale, 'not at all willing'=0 and 'very willing'=10), success of participant, therapist and outcome assessor blinding, adverse events and Global Perceived Effect Scale. Secondary outcomes were pain, function and measures of physiological mechanisms.
86 people were screened, 31 (36%) were randomised, 28 (90%) completed the treatments and 3 (10%) dropouts at 3-month follow-up. Both groups had high treatment attendance (98.4% and 100%). All participants scored at least 7 on the willingness to undergo therapy scale. Blinding was successful. No adverse events were reported. At the postintervention assessment, 80% in the AR+EX group and 75% in the SR+EX group reported an improvement on the Global Perceived Effect Scale. Both groups demonstrated within-group improvements in pain at the postintervention assessment but not at the 3-month follow-up. Function improved only in the AR+EX group at the postintervention assessment.
Combined rTMS and quadriceps strengthening exercise intervention for knee osteoarthritis is feasible, safe and well-received. A full-scale trial is justified to assess the clinical benefits of this novel treatment.
ACTRN12621001712897.
探讨重复经颅磁刺激(rTMS)联合股四头肌强化运动干预对膝骨关节炎的可行性、安全性及患者的感知反应。
一项双臂、参与者设盲、治疗师设盲和评估者设盲的随机对照试验,并在3个月时额外随访疼痛和功能情况。参与者被随机分为接受主动rTMS+运动(AR+EX)或假rTMS+运动(SR+EX),每周两次,共6周,同时每周在家完成两次运动。主要结局包括招募率、治疗出勤率、退出率、接受治疗的意愿(11点数字评定量表,“完全不愿意”=0,“非常愿意”=10)、参与者、治疗师和结局评估者设盲的成功情况、不良事件和整体感知效应量表。次要结局为疼痛、功能及生理机制指标。
共筛查86人,31人(36%)被随机分组,28人(90%)完成治疗,3人(10%)在3个月随访时退出。两组的治疗出勤率均较高(分别为98.4%和100%)。所有参与者在接受治疗意愿量表上的得分至少为7分。设盲成功。未报告不良事件。在干预后评估中,AR+EX组80%的参与者和SR+EX组75%的参与者报告整体感知效应量表有所改善。两组在干预后评估时组内疼痛均有改善,但在3个月随访时未改善。仅AR+EX组在干预后评估时功能有所改善。
rTMS联合股四头肌强化运动干预对膝骨关节炎是可行、安全且广受认可的。进行全面试验以评估这种新治疗方法的临床益处是合理的。
ACTRN12621001712897。