Sarı İlker Fatih, İlhanlı İlker, Mızrak Tuba, Kulaklı Fazıl, Kasap Zerrin
The Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Giresun University, Gazipaşa Yerleşkesi Debboy Mevki Giresun/Türkiye, Giresun 28200, Turkey.
The Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Ondokuz Mayıs University, Samsun 55139, Turkey.
J Clin Med. 2023 Jul 29;12(15):4989. doi: 10.3390/jcm12154989.
This study aimed to investigate the effectiveness of posterior tibial nerve stimulation (PTNS) in reducing pain, improving quality of life, and decreasing disease severity in patients with fibromyalgia. This prospective, single-blind, randomized controlled trial included female patients newly diagnosed with fibromyalgia who had started duloxetine treatment (30 mg/day). The patients in the study group received six sessions of posterior tibial nerve stimulation, twice weekly, 3-4 days apart, in addition to duloxetine; the controls received duloxetine only. The patients were evaluated three times (at baseline, 1st month, and 3rd month). Pain was evaluated using a numeric rating scale, the short-form McGill Pain Questionnaire, and quality of life with a 36-item short-form health survey (SF-36). Patient functional status and disease severity were evaluated using the fibromyalgia impact questionnaire (FIQ). A total of 64 patients met the inclusion criteria: 22 were ultimately included in the study group and 30 in the control group. Statistical improvements in pain and FIQ scores were observed after treatment in both groups. The SF-36 scores indicated improved vitality only in the 1st month in both groups, with no significant changes in the other quality-of-life subscales in either group. There was no statistical difference between the two groups in terms of changes in pain, FIQ, and SF-36 scores compared with baseline at the 1st month and 3rd month. The addition of PTNS to pharmacological treatment did not contribute to the reduction in pain or improvement in quality of life in fibromyalgia either in the 1st or 3rd month. NIH Clinical Trial Registration Number NCT05937711.
本研究旨在探讨胫后神经刺激（PTNS）在减轻纤维肌痛患者疼痛、改善生活质量和降低疾病严重程度方面的有效性。这项前瞻性、单盲、随机对照试验纳入了新诊断为纤维肌痛且已开始度洛西汀治疗（30毫克/天）的女性患者。研究组患者除度洛西汀外，每周接受两次胫后神经刺激，共六次，每次间隔3 - 4天；对照组仅接受度洛西汀治疗。对患者进行了三次评估（基线、第1个月和第3个月）。使用数字评分量表、简短麦吉尔疼痛问卷评估疼痛，使用36项简短健康调查（SF - 36）评估生活质量。使用纤维肌痛影响问卷（FIQ）评估患者功能状态和疾病严重程度。共有64名患者符合纳入标准：最终22名患者被纳入研究组，30名患者被纳入对照组。两组治疗后疼痛和FIQ评分均有统计学改善。SF - 36评分显示两组仅在第1个月活力有所改善，两组其他生活质量子量表均无显著变化。在第1个月和第个月时，两组在疼痛、FIQ和SF - 36评分相对于基线的变化方面无统计学差异。在第1个月或第3个月，在药物治疗基础上加用PTNS对减轻纤维肌痛患者的疼痛或改善生活质量均无帮助。美国国立医学图书馆临床试验注册号NCT05937711。
