Jia Pengli, Liu Jiali, Li Ling, Luo Yanan, Li Ying, Zhao Ling, Liang Fanrong, Liu Zhibin, Zou Kang, Tang Li, Sun Xin
Chinese Evidence-based Medicine Center and Cochrane China Center, West China Hospital, Sichuan University, 37 Guo Xue Xiang, Chengdu, 610041 Sichuan China.
Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine, Chengdu, 610000 Sichuan China.
Pilot Feasibility Stud. 2020 Sep 28;6:144. doi: 10.1186/s40814-020-00687-x. eCollection 2020.
Although previous clinical studies suggest possible benefits of acupuncture for knee osteoarthritis (KOA), the value of acupuncture at sensitized points is uncertain. We aimed to preliminarily assess the feasibility of performing a definitive randomized controlled trial to explore the effectiveness of acupuncture for KOA with highly sensitized acupoints.
In this randomized, single-blind, parallel, pilot trial, 36 participants with KOA were randomly assigned to receive acupuncture at highly sensitized acupoints (high-sensitization group) or at low/non-sensitized points (low/non-sensitization group) by a computer-generated random sequence. Both groups received three treatment sessions per week for four consecutive weeks (12 sessions in total). Assessments were performed at screening and at 4, 8, 12, and 16 weeks after randomization. Primary feasibility outcomes were patient recruitment, retention rate, and adherence to group treatment. Secondary outcomes included the change of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score from baseline to 16 weeks, the change of Short Form (SF)-12 health survey score, and safety outcomes.
Patient recruitment of 36 patients took 2 months, achieving the recruitment target. Retention rates were similar between the treatment groups, 14 (77.8%) patients in the high-sensitization group completed the 16-week follow-up and compared to 14 (77.8%) patients in low/non-sensitization group, but the result was lower than expected. All patients received at least ten treatment sessions in total. The WOMAC total score and the pain, stiffness, and physical function score in the high-sensitization group were lower or very close to those in the control group at each assessment point. Similar results were observed on quality of life. No adverse events occurred.
This trial has presented preliminary data on the feasibility of conducting a large trial to test the effectiveness of acupuncture at sensitized points in KOA patients.
ClinicalTrials.gov, NCT03008668. Registered on 26 December 2016-retrospectively registered.
尽管先前的临床研究表明针灸对膝关节骨关节炎（KOA）可能有益，但针刺敏化点的价值尚不确定。我们旨在初步评估进行一项确定性随机对照试验的可行性，以探讨针刺高敏穴位治疗KOA的有效性。
在这项随机、单盲、平行对照的试点试验中，36例KOA患者通过计算机生成的随机序列被随机分配接受高敏穴位针刺（高敏化组）或低敏/非敏化穴位针刺（低敏/非敏化组）。两组均每周接受3次治疗，连续4周（共12次）。在筛选时以及随机分组后4、8、12和16周进行评估。主要可行性指标为患者招募情况、保留率和对分组治疗的依从性。次要指标包括从基线到16周时西安大略和麦克马斯特大学骨关节炎指数（WOMAC）总分的变化、简短健康调查（SF）-12评分的变化以及安全性指标。
招募36例患者用时2个月，达到了招募目标。治疗组之间的保留率相似，高敏化组14例（77.8%）患者完成了16周的随访，低敏/非敏化组为14例（77.8%），但结果低于预期。所有患者总共至少接受了10次治疗。在每个评估点，高敏化组的WOMAC总分以及疼痛、僵硬和身体功能评分均低于或非常接近对照组。在生活质量方面也观察到了类似结果。未发生不良事件。
本试验提供了初步数据，表明进行一项大型试验以测试针刺KOA患者敏化点有效性的可行性。
ClinicalTrials.gov，NCT03008668。于2016年12月26日注册——回顾性注册。
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