Arthritis Research Campaign National Primary Care Centre, Keele University, Staffordshire ST5 5BG, UK.
BMC Musculoskelet Disord. 2009 Dec 11;10:156. doi: 10.1186/1471-2474-10-156.
Tennis elbow is a common and often extremely painful musculoskeletal condition, which has considerable impact on individuals as well as economic implications for healthcare utilization and absence from work. Many management strategies have been studied in clinical trials. Whilst corticosteroid injections offer short term pain relief, this treatment is unpleasant and is used with caution due to an associated high risk of pain recurrence in the long term. Systematic reviews conclude that there is no clear and effective treatment for symptoms of pain in the first 6 weeks of the condition. There is a clear need for an intervention that is acceptable to patients and provides them with effective short-term pain relief without increasing the risk of recurrence. Transcutaneous electrical nerve stimulation (TENS) is an inexpensive, non-invasive, non-pharmacological form of analgesia that is commonly used in the treatment of pain. TENS has very few contraindications and is simple to apply. It also benefits from being patient controlled, thereby promoting self-management. This study aims to assess the effectiveness, in terms of pain relief, and cost-effectiveness of a self-management package of treatment that includes TENS.
METHODS/DESIGN: The design of the study will be a two-group pragmatic randomized clinical trial. 240 participants aged 18 years and over with tennis elbow will be recruited from 20-30 GP practices in Staffordshire, UK. Participants are to be randomized on a 1:1 basis to receive either primary care management (standard GP consultation, medication, advice and education) or primary care management with the addition of TENS, over 6 weeks. Our primary outcome measure is average intensity of elbow pain in the past 24 hours (0-10 point numerical rating scale) at 6 weeks. Secondary outcomes include pain and limitation of function, global assessment of change, days of sick leave, illness perceptions, and overall health status. A cost-effectiveness analysis will also be performed. Patient adherence and satisfaction data will be collected at 6 weeks, 6 months and 12 months by postal questionnaire. A diary will also be completed for the first 2 weeks of treatment. Clinical effectiveness and cost-effectiveness analyses will be carried out using an intention-to-treat approach as the primary analysis.
This paper presents detail on the rationale, design, methods and operational aspects of the trial.
Current Controlled Trials. ISRCTN87141084.
网球肘是一种常见且常非常疼痛的肌肉骨骼疾病，它对个人有很大的影响，同时也对医疗保健的利用和缺勤造成经济影响。许多管理策略已经在临床试验中进行了研究。虽然皮质类固醇注射可以提供短期的疼痛缓解，但这种治疗方法令人不快，并且由于长期疼痛复发的风险较高，因此谨慎使用。系统评价的结论是，对于该疾病的前 6 周的疼痛症状，没有明确和有效的治疗方法。显然需要一种对患者可接受的干预措施，为他们提供有效的短期疼痛缓解，而不会增加复发的风险。经皮神经电刺激（TENS）是一种廉价、非侵入性、非药物形式的镇痛方法，常用于疼痛的治疗。TENS 的禁忌症很少，应用简单。它还受益于患者控制，从而促进自我管理。本研究旨在评估包括 TENS 在内的自我管理治疗方案在缓解疼痛方面的有效性和成本效益。
方法/设计：该研究的设计将是一项两臂实用随机临床试验。将从英国斯塔福德郡的 20-30 个全科医生实践中招募 240 名年龄在 18 岁及以上的网球肘患者。参与者将按照 1:1 的比例随机分为两组，分别接受初级保健管理（标准全科医生咨询、药物、建议和教育）或初级保健管理加 TENS，为期 6 周。我们的主要结局测量指标是过去 24 小时内肘部疼痛的平均强度（0-10 点数字评分量表）在 6 周时。次要结局包括疼痛和功能受限、总体变化评估、病假天数、疾病认知和总体健康状况。还将进行成本效益分析。患者的依从性和满意度数据将在 6 周、6 个月和 12 个月时通过邮寄问卷收集。治疗的前 2 周还将填写日记。临床有效性和成本效益分析将采用意向治疗方法作为主要分析。
本文介绍了试验的原理、设计、方法和操作方面的详细信息。
当前对照试验。ISRCTN87141084。
