1 Centre for Health, Activity, and Rehabilitation Research, School of Physiotherapy, University of Otago, Dunedin, New Zealand.
2 Centre for Health and Rehabilitation Technologies, Institute of Nursing & Health Research, School of Health Sciences, Ulster University, Belfast, UK.
Clin Rehabil. 2017 Dec;31(12):1592-1603. doi: 10.1177/0269215517705690. Epub 2017 May 1.
To evaluate the feasibility of a randomized controlled trial investigating the optimal number of treatment sessions of acupuncture, used as an adjunct to usual care, for managing chronic low back pain.
In total, 45 participants with chronic low back pain were recruited and randomly allocated to receive usual care plus 4, 7, or 10 sessions of acupuncture (15/group). Primary outcomes were recruitment rate, randomization rate, treatment compliance, completion of the outcome measures, and retention rates. Secondary outcomes included back function, pain intensity and bothersomeness, generic health status, activity disability, and participant satisfaction. Data were collected at baseline and discharge, and at 6 and 12 weeks post randomization.
The recruitment method was demonstrated to be successful: recruitment rate was 43.7%, and randomization rate was 100%. Compliance with treatment was high among participants (86.7%, 86.7%, and 100% for the 4-, 7-, and 10-session group, respectively). Outcome questionnaires used in this study were found to be appropriate for a future randomized controlled trial. Participant retention rates were 88.9% at discharge and at 6 weeks post randomization and 84.4% at 12 weeks post randomization. Secondary outcomes (except for pain intensity) favored the 10-session acupuncture group at 12 weeks post randomization. Over 90% of participants indicated that they were "very satisfied" and/or "extremely satisfied" with the acupuncture treatment.
This study demonstrated that a full-scale randomized controlled trial using the methodology described above is feasible, and such a trial is essential to test the dose dependence of acupuncture.
评估一项随机对照试验的可行性，该试验旨在研究作为常规护理辅助手段的针刺治疗慢性下腰痛的最佳治疗次数。
共招募了 45 名慢性下腰痛患者，并随机分为接受常规护理加 4、7 或 10 次针刺治疗（每组 15 例）。主要结局指标为招募率、随机化率、治疗依从性、完成结局测量和保留率。次要结局指标包括背部功能、疼痛强度和困扰、一般健康状况、活动残疾和患者满意度。数据在基线和出院时以及随机分组后 6 周和 12 周收集。
招募方法被证明是成功的：招募率为 43.7%，随机化率为 100%。参与者对治疗的依从性很高（分别为 4、7 和 10 次组的 86.7%、86.7%和 100%）。本研究中使用的结局问卷适合未来的随机对照试验。出院时和随机分组后 6 周的患者保留率分别为 88.9%和 84.4%，随机分组后 12 周的保留率为 84.4%。次要结局（除疼痛强度外）在随机分组后 12 周时偏向于 10 次针刺组。超过 90%的参与者表示他们对针刺治疗“非常满意”和/或“极其满意”。
本研究表明，采用上述方法进行全面的随机对照试验是可行的，该试验对于测试针刺的剂量依赖性至关重要。
