Chinese Medicine Services, Pok Oi Hospital, Hong Kong SAR, China.
School of Chinese Medicine, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong SAR, China.
Trials. 2019 Aug 7;20(1):480. doi: 10.1186/s13063-019-3572-4.
Heel pain is a common foot disorder that causes pain and functional limitations. The prevalence of disabling foot pain will increase as the population ages. Previous studies have reported the positive therapeutic effects of electroacupuncture, warm needling, or the combination of both for heel pain but with limitations in the study methodologies. The current study is a rigorously designed randomized controlled trial that aims to evaluate the clinical efficacy and safety of electroacupuncture plus warm needling therapy in patients with heel pain.
METHODS/DESIGN: The study protocol describes a prospective, open-label, parallel-group, randomized controlled trial to be conducted in Hong Kong. Eighty patients aged 50-80 years who have reported heel pain and first-step pain equal to or exceeding 50 mm on the 100-mm visual analog scale (VAS) will be recruited. They will be randomly assigned (1:1 ratio) to the electroacupuncture plus warm needling therapy (i.e., treatment) group or the waitlist (i.e., control) group. The treatment group will undergo six treatment sessions in 4 weeks. The control group will receive no treatment during the study period. The primary outcome measure is a mean change in the first-step pain VAS score from the baseline to week 4. Secondary outcome measures include a mean change in first-step pain VAS score from the baseline to week 2, a mean change in Foot Function Index (FFI) subscale scores and the total score from the baseline to week 2 and week 4, and patients' self-reported level of improvement at week 4. Additional week 8 follow-up assessments with first-step pain VAS and FFI measurements will be arranged for the treatment group. Any adverse events will be recorded throughout the study to evaluate safety. An intention-to-treat approach will be used to analyze the study results.
This study will provide evidence on the efficacy and safety of electroacupuncture plus warm needling therapy as an alternative treatment method for heel pain. The findings will determine whether the treatment protocol is efficacious in relieving pain and improving foot function among older adults with heel pain. The study will also provide information for subsequent large-scale randomized controlled trials in the future.
Chinese Clinical Trial Registry, ChiCTR1800014906 . Registered on 12 February 2018.
足跟痛是一种常见的足部疾病，会引起疼痛和功能受限。随着人口老龄化，致残性足部疼痛的患病率将会增加。既往研究报告称，电针、温针灸或两者联合治疗足跟痛具有积极的治疗效果，但研究方法存在局限性。本研究是一项设计严谨的随机对照试验，旨在评估电针加温针灸疗法治疗足跟痛患者的临床疗效和安全性。
方法/设计：该研究方案描述了一项在香港进行的前瞻性、开放性、平行组、随机对照试验。将招募 80 名年龄在 50-80 岁之间的患者，这些患者自述足跟痛，且首次迈步疼痛评分（VAS）等于或大于 50mm（VAS 评分范围为 0-100mm，评分越高表示疼痛越剧烈）。他们将被随机分配（1:1 比例）到电针加温针灸治疗（即治疗）组或候补组（即对照组）。治疗组在 4 周内接受 6 次治疗。对照组在研究期间不接受任何治疗。主要结局指标是从基线到第 4 周时首次迈步疼痛 VAS 评分的平均变化。次要结局指标包括从基线到第 2 周和第 4 周时首次迈步疼痛 VAS 评分的平均变化、从基线到第 2 周和第 4 周时足部功能指数（FFI）分量表评分和总分的平均变化，以及第 4 周时患者自我报告的改善程度。还将为治疗组安排第 8 周的随访评估，包括首次迈步疼痛 VAS 和 FFI 测量。在整个研究过程中记录任何不良反应以评估安全性。将采用意向治疗方法分析研究结果。
本研究将提供电针加温针灸治疗足跟痛的疗效和安全性证据。研究结果将确定该治疗方案是否能有效缓解老年人足跟痛的疼痛并改善其足部功能。该研究还将为未来的大型随机对照试验提供信息。
中国临床试验注册中心，ChiCTR1800014906。注册于 2018 年 2 月 12 日。
