Centre d'investigation Clinique - Epidémiologie Clinique/Essais Cliniques (CIE3), CHU de Saint-Etienne, Saint-Etienne Cedex, France.
Eur J Pain. 2012 May;16(5):656-65. doi: 10.1002/j.1532-2149.2011.00061.x. Epub 2011 Dec 20.
OBJECTIVES: To evaluate the efficacy of transcutaneous electrical neurostimulation (TENS) in patients with chronic low back pain (LBP). DESIGN: Prospective, randomized, multicentre, single-blind study. SETTING: Twenty-one French pain centres. PARTICIPANTS: Two hundred thirty-six consecutive adult patients consulting for chronic LBP, with or without radicular pain (mean age ± standard deviation: 53 ± 13 years; range: 28-86 years). INTERVENTION: Patients were randomly assigned to receive either active (n = 117) or sham (n = 119) TENS in four 1-h daily treatment sessions for 3 months. MAIN OUTCOME MEASURES: The primary outcome measured was improvement of functional status at 6 weeks (Roland-Morris Disability Questionnaire). Secondary outcome measures were improvement of functional status at 3 months, pain relief (weekly visual analogue scale assessments), positive functional repercussions of pain levels on quality of life, a diminution of the use of analgesic and anti-inflammatory medication, satisfaction with the overall treatment strategy and compliance. RESULTS: Functional status did not differ between the groups, whether at 6 weeks or 3 months (p = 0.351 at 6 weeks). A significant improvement between the first and last visual analogue scale assessments was observed in patients with either lumbar pain alone or lumbar and radicular pain treated with active TENS. Other outcome measures did not differ significantly between the two groups. CONCLUSION: There was no functional benefit of TENS in the treatment of patients with chronic LBP.
目的:评估经皮神经电刺激(TENS)治疗慢性下背痛(LBP)患者的疗效。
设计:前瞻性、随机、多中心、单盲研究。
地点:21 个法国疼痛中心。
参与者:236 名连续就诊的慢性 LBP 成年患者,伴或不伴根性疼痛(平均年龄±标准差:53±13 岁;范围:28-86 岁)。
干预:患者被随机分为接受真 TENS(n=117)或假 TENS(n=119)治疗,每天 4 次,每次 1 小时,持续 3 个月。
主要观察指标:主要观察指标为治疗 6 周时的功能状态改善(Roland-Morris 残疾问卷)。次要观察指标为治疗 3 个月时的功能状态改善、疼痛缓解(每周视觉模拟量表评估)、疼痛对生活质量的积极功能影响、镇痛药和抗炎药使用减少、对整体治疗策略的满意度和依从性。
结果:无论在 6 周还是 3 个月时,两组的功能状态均无差异(6 周时 p=0.351)。接受真 TENS 治疗的单纯腰痛或腰痛伴根性疼痛患者,其首次和末次视觉模拟量表评估之间的功能状态显著改善。两组的其他观察指标无显著差异。
结论:TENS 治疗慢性 LBP 患者在功能改善方面无获益。
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