Department of Medical Research, Korea Institute of Oriental Medicine, Daejeon, South Korea.
Trials. 2013 Jun 14;14:174. doi: 10.1186/1745-6215-14-174.
Lateral epicondylitis is the most frequent cause of pain around the elbow joint. It causes pain in the region of the elbow joint and results in dysfunction of the elbow and deterioration of the quality of life. The purpose of this study is to compare the effects of ipsilateral acupuncture, contralateral acupuncture and sham acupuncture on lateral epicondylitis.
METHODS/DESIGN: Forty-five subjects with lateral epicondylitis will be randomized into three groups: the ipsilateral acupuncture group, contralateral acupuncture group and the sham acupuncture group. The inclusion criteria will be as follows: (1) age between 19 and 65 years with pain due to one-sided lateral epicondylitis that persisted for at least four weeks, (2) with tenderness on pressure limited to regions around the elbow joint, (3) complaining of pain during resistive extension of the middle finger or the wrist, (4) with average pain of NRS 4 or higher during the last one week at a screening visit and (5) voluntarily agree to this study and sign a written consent. Acupuncture treatment will be given 10 times in total for 4 weeks to all groups. Follow up observations will be conducted after the completion of the treatment, 8 weeks and 12 weeks after the random assignment. Ipsilateral acupuncture group and contralateral acupuncture group will receive acupuncture on LI4, TE5, LI10, LI11, LU5, LI12 and two Ashi points. The sham acupuncture group will receive treatment on acupuncture points not related to the lateral epicondylitis using a non-invasive method. The needles will be maintained for 20 minutes. The primary outcome will be differences in the visual analogue scale (VAS) for elbow pain between the groups. The secondary outcome will be differences in patient-rated tennis elbow evaluation (PRTEE), pain-free/maximum grip strength (Dynamometer), pressure pain threshold, clinically relevant improvement, patient global assessment, and the EQ-5D. The data will be analyzed with the paired t-test and ANCOVA (P <0.05).
The results of this study will allow evaluation of contralateral acupuncture from two aspects. First, if the contralateral acupuncture shows the effects similar to ipsilateral acupuncture, this will establish clinical basis for contralateral acupuncture. Second, if the effects of contralateral acupuncture are not comparable to the effects of ipsilateral acupuncture, but are shown to be similar to the effects of the sham acupuncture, we can establish the basis for using the same acupoints of the unaffected side as a control in acupuncture clinical studies.
This trial has been registered with the 'Clinical Research Information Service (CRIS)', Republic of Korea: KCT0000628.
外侧肱骨上髁炎是肘部关节周围最常见的疼痛原因。它会导致肘部区域疼痛，并导致肘部功能障碍和生活质量恶化。本研究的目的是比较同侧针刺、对侧针刺和假针刺对外侧肱骨上髁炎的疗效。
方法/设计：将 45 名患有外侧肱骨上髁炎的患者随机分为三组：同侧针刺组、对侧针刺组和假针刺组。纳入标准如下：（1）年龄在 19 至 65 岁之间，因单侧外侧肱骨上髁炎疼痛持续至少四周，（2）肘部关节周围有压痛，（3）抵抗性伸展中指或手腕时疼痛，（4）在筛选就诊时过去一周平均疼痛 NRS 4 或更高，（5）自愿参加本研究并签署书面同意书。三组均给予 10 次针刺治疗，共 4 周。治疗完成后、随机分组后 8 周和 12 周进行随访观察。同侧针刺组和对侧针刺组在 LI4、TE5、LI10、LI11、LU5、LI12 和两个阿是穴进行针刺。假针刺组采用非侵入性方法在与外侧肱骨上髁炎无关的穴位进行治疗。将针保持 20 分钟。主要结局指标为三组间肘部疼痛视觉模拟评分（VAS）的差异。次要结局指标为患者网球肘评定量表（PRTEE）、无痛/最大握力（测力计）、压痛阈值、临床相关改善、患者整体评估和 EQ-5D 的差异。采用配对 t 检验和协方差分析（P<0.05）进行数据分析。
本研究结果将从两个方面评价对侧针刺。首先，如果对侧针刺的效果与同侧针刺相似，这将为对侧针刺提供临床依据。其次，如果对侧针刺的效果与同侧针刺不相当，而是与假针刺的效果相似，我们可以为在针刺临床研究中使用对侧相同穴位作为对照建立依据。
本试验已在韩国“临床研究信息服务（CRIS）”注册：KCT0000628。
