Department of Physical Medicine and Rehabilitation, Shin Kong Wu Ho-Su Memorial Hospital, Taipei, Taiwan.
J Pain Symptom Manage. 2010 Jan;39(1):116-25. doi: 10.1016/j.jpainsymman.2009.05.016. Epub 2009 Oct 12.
Locally administered nonsteroidal anti-inflammatory drugs have been widely used in acute soft-tissue damage and articular musculoskeletal pain. This double-blind, placebo-controlled, randomized study was designed to evaluate the efficacy and safety of a topical diclofenac sodium patch in the relief of pain and inflammation as a result of myofascial pain syndrome (MPS) in the upper trapezius. After sample size calculations indicated that 147 patients would be needed to detect a 25% difference between drug and control, 153 patients with MPS were recruited and randomized to receive either a diclofenac sodium patch or control (menthol) patch. Visual analog scale (VAS), cervical active range of motion, pressure pain threshold of the myofascial trigger point (MTrP), patient global assessment, Neck Disability Index, and the occurrence of adverse events were assessed on Day 0 (baseline), Day 4, and Day 8. Use of the diclofenac sodium patch elicited favorable responses for the VAS, cervical active range of motion, and Neck Disability Index by the end of the treatment course (P<0.05), and was consistently superior to the control patch at all time intervals. No significant differences were observed for the pressure pain threshold of the MTrP for either patch. Tolerability assessment similarly showed the diclofenac patch to be comparatively superior. When assessed at the end of the study, 20 diclofenac patch patients, but only four control patients, considered the tolerability of treatment to be "very good." Significant differences in adverse reactions were observed between the diclofenac and control patches, with the control patch more likely to produce overall skin irritation. This study demonstrate that the diclofenac sodium patch was superior to the control patch in terms of reducing pain and improving functional outcomes, and did not result in significant adverse effects.
局部给予的非甾体类抗炎药已广泛用于急性软组织损伤和关节肌肉骨骼疼痛。本双盲、安慰剂对照、随机研究旨在评估双氯芬酸钠贴剂治疗上斜方肌肌筋膜疼痛综合征（MPS）引起的疼痛和炎症的疗效和安全性。根据样本量计算，需要 147 例患者才能检测到药物和对照组之间 25%的差异，共招募了 153 例 MPS 患者并随机分为双氯芬酸钠贴剂组或对照组（薄荷醇贴剂）。在第 0 天（基线）、第 4 天和第 8 天评估视觉模拟评分（VAS）、颈椎主动活动范围、肌筋膜触发点（MTrP）的压痛阈、患者总体评估、颈椎残疾指数和不良事件的发生情况。在治疗结束时（P<0.05），双氯芬酸钠贴剂组的 VAS、颈椎主动活动范围和颈椎残疾指数均有较好的反应，且在所有时间间隔均优于对照组。两种贴剂的 MTrP 压痛阈无显著差异。对耐受性的评估同样显示双氯芬酸贴剂具有相对优势。在研究结束时评估，20 例双氯芬酸贴剂患者，而只有 4 例对照组患者认为治疗的耐受性“非常好”。双氯芬酸贴剂和对照组之间观察到不良反应有显著差异，对照组更可能引起整体皮肤刺激。本研究表明，双氯芬酸钠贴剂在减轻疼痛和改善功能结局方面优于对照组，且不会产生显著的不良反应。
