Radpasand Mohsen, Owens Edward
Shipman Chiropractic Clinic, Davenport, Iowa 52807, USA.
J Manipulative Physiol Ther. 2009 Sep;32(7):571-85. doi: 10.1016/j.jmpt.2009.08.010.
The objective of this project was to develop and test protocols for a randomized clinical trial (RCT) of 2 multimodal package therapies for chronic lateral epicondylitis.
Six participants were enrolled after case review and randomized to 1 of 2 groups (4 in group A and 2 in group B). Group A had high-velocity low-amplitude manipulation, high-voltage pulse galvanic stimulation, counterforce bracing, ice, and exercises, whereas group B had ultrasound, counterforce bracing, and exercise. Both groups had 12 weeks of active care and instructed to restrict usage of the affected elbow. Participants filled out a visual analog scale and the Patient Rated Tennis Elbow Evaluation every week. The pain-free grip strength test was measured at baseline, and at the end of the third, sixth, ninth, and twelfth visits.
One participant in group A dropped out before the end of care. Both groups demonstrated changes in all of the outcome variables from the baseline to the end point (12 weeks) of treatment. Sample size for a larger future randomized clinical trial was calculated as n = 246 participants.
The pilot study demonstrated that the study design is feasible and that patients could be recruited for a 12-week trial of multimodal treatment. A larger trial is warranted in a multicenter setting to detect differences in the effects of these treatment strategies.
本项目的目的是为一项针对慢性外侧上髁炎的两种多模式综合治疗方案的随机临床试验（RCT）制定并测试方案。
经病例审查后招募了6名参与者，并随机分为2组中的1组（A组4人，B组2人）。A组接受高速低幅手法治疗、高压脉冲电刺激、反作用力支具、冰敷和锻炼，而B组接受超声治疗、反作用力支具和锻炼。两组均接受12周的积极治疗，并被指示限制患侧肘部的使用。参与者每周填写一次视觉模拟量表和患者网球肘评估量表。在基线时以及第三次、第六次、第九次和第十二次就诊结束时测量无痛握力测试。
A组有1名参与者在治疗结束前退出。两组从基线到治疗终点（12周）的所有结局变量均有变化。计算得出未来一项更大规模随机临床试验的样本量为n = 246名参与者。
该初步研究表明研究设计是可行的，并且可以招募患者进行为期12周的多模式治疗试验。有必要在多中心环境中进行更大规模的试验，以检测这些治疗策略效果的差异。
