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经皮神经电刺激作为网球肘初级保健管理的辅助手段:实用随机对照试验 (TATE 试验)。

Transcutaneous electrical nerve stimulation as adjunct to primary care management for tennis elbow: pragmatic randomised controlled trial (TATE trial).

机构信息

Arthritis Research UK Primary Care Centre, Keele University, Keele, Staffordshire ST5 5BG, UK.

出版信息

BMJ. 2013 Sep 2;347:f5160. doi: 10.1136/bmj.f5160.

DOI:10.1136/bmj.f5160
PMID:23999980
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3759476/
Abstract

OBJECTIVE

To investigate the effectiveness of supplementing information and advice on analgesia and exercise from a general practitioner with transcutaneous electrical nerve stimulation (TENS) as a non-drug form of analgesia to reduce pain intensity in patients with tennis elbow.

DESIGN

Pragmatic randomised controlled trial in primary care.

SETTING AND

38 general practices in the West Midlands, UK.

PARTICIPANTS

241 adults consulting with a first or new (no consultation in previous six months) clinical diagnosis of tennis elbow.

INTERVENTIONS

Participants were randomly allocated to either primary care management alone, consisting of a consultation with a general practitioner followed by information and advice on exercises, or primary care management plus TENS to be used once a day for 45 minutes over six weeks (or until symptom resolution) for pain relief.

OUTCOME MEASURES

The primary outcome was self reported intensity of elbow pain (0-10 rating scale) at six weeks. Primary and secondary outcomes were measured at baseline and at six weeks, six months, and 12 months by postal questionnaire. Analysis was by intention to treat.

RESULTS

121 participants were randomised to primary care management plus TENS and 120 to primary care management only (first episode, n=197 (82%); duration <1-3 months, n=138 (57%)). Adherence to exercise and TENS recommendations reported at six weeks was low; only 42 participants in the primary care management plus TENS group met a priori defined adherence criteria. Both intervention groups showed large improvements in pain and secondary outcomes, especially during the first six weeks of follow-up. However, no clinically or statistically significant differences were seen between groups at any follow-up timepoint. At the primary endpoint (six weeks), the between group difference in improvement of pain was -0.33 (95% confidence interval -0.96 to 0.31; P=0.31) in favour of the primary care management only group, with adjustment for age, sex, and baseline pain score.

CONCLUSIONS

This trial does not provide evidence for additional benefit of TENS as an adjunct to primary care management of tennis elbow. Poor adherence to interventions is evidence of the challenges of implementing self management treatment strategies in primary care.

TRIAL REGISTRATION

Current Controlled Trials ISRCTN87141084.

摘要

目的

研究在全科医生补充经皮神经电刺激(TENS)镇痛和运动信息和建议的基础上,作为一种非药物镇痛形式,是否可以降低网球肘患者的疼痛强度。

设计

在初级保健中进行的实用随机对照试验。

设置和地点

英国西米德兰兹 38 家全科诊所。

参与者

241 名成年人首次或新出现(在过去六个月内没有就诊)临床诊断为网球肘。

干预措施

参与者被随机分配到仅接受全科医疗管理组,该组包括与全科医生的咨询,以及关于运动的信息和建议,或接受全科医疗管理加 TENS 治疗,每天一次,持续六周(或直至症状缓解),以缓解疼痛。

主要结局指标

主要结局是六周时自我报告的肘部疼痛强度(0-10 评分量表)。主要和次要结局在基线时以及六周、六个月和十二个月时通过邮寄问卷进行测量。分析采用意向治疗。

结果

121 名参与者被随机分配到全科医疗管理加 TENS 组,120 名参与者被随机分配到仅接受全科医疗管理组(首发病例,n=197(82%);病程<1-3 个月,n=138(57%))。在六周时,报告的运动和 TENS 建议的依从性较低;只有 TENS 组的 42 名参与者符合预先确定的依从性标准。两组患者的疼痛和次要结局均有较大改善,尤其是在随访的前六周。然而,在任何随访时间点均未观察到两组之间有临床或统计学上的显著差异。在主要终点(六周),与仅接受全科医疗管理组相比,TENS 组的疼痛改善程度差异为-0.33(95%置信区间-0.96 至 0.31;P=0.31),调整了年龄、性别和基线疼痛评分。

结论

本试验未提供 TENS 作为网球肘初级保健管理辅助治疗的额外益处的证据。对干预措施的依从性较差表明,在初级保健中实施自我管理治疗策略存在挑战。

试验注册

当前对照试验 ISRCTN87141084。

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