Efficacy of Conservative Versus Surgical Therapy for Carpal Tunnel Syndrome: a Randomised Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Changes in the intensity of pain symptoms between baseline and follow-up periods
研究概览
简要总结
It is a randomized clinical trial comparing surgical and conservative (physical therapy) treatments for women with carpal tunnel syndrome (CTS). The purpose of the study is to determine the efficacy of physical therapy versus endoscopic surgery in pain and disability in women with carpal tunnel syndrome at medium and long-term follow-up periods. We hypothesized that proper physical therapy approach can be equally effective than surgical intervention for improving pain and function in patients with carpal tunnel syndrome.
详细描述
Scientific evidence for the management of CTS has exhibited conflicting results. The Cochrane review concluded that surgical treatment relieves symptoms significantly better than splinting but further research is needed. A systematic review focused on physical therapy for the management of CTS included 6 studies and found weak to strong effect of neural gliding exercises. Recent studies have revealed complex nociceptive mechanisms involved in CTS which should be carefully considered during the management of these patients. Proper physical therapy interventions can modulate nociceptive processes found in CTS. We will perform a randomized clinical trial nested within a prospective cohort as our study design to determine if proper physical therapy approach targeted to modulate sensitization processes is equally effective than surgical intervention for improving pain and function in patients with carpal tunnel syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •pain and paresthesia in the median nerve distribution without extra-median nerve territory symptoms;
- •increasing symptoms during night;
- •Tinel sign;
- •Phalen sign;
- •self-reported hand strength deficits.
- •Deficits of sensory and motor nerve conduction of the median nerve according to standardized guidelines of the American Association of Electrodiagnosis, American Academy of Neurology, and the American Academy of Physical Medicine and Rehabilitation
排除标准
- •if any sensory/motor deficit in ulnar or radial nerve was present;
- •previous interventions with surgery or steroid injections;
- •multiple diagnoses of the upper extremity (i.e., cervical radiculopathy, lateral epicondylalgia);
- •history of neck, shoulder or arm trauma;
- •history of a systemic disease causing CTS (e.g. diabetes mellitus, or thyroid disease);
- •history of systemic musculoskeletal conditions (e.g. rheumatoid arthritis, fibromyalgia);
- •if the patient was actively involved with or seeking litigation at the time of the study;
- •pregnancy.
结局指标
主要结局
Changes in the intensity of pain symptoms between baseline and follow-up periods
时间窗: Baseline and 1, 3, 6 and 12 months after the intervention
A 10-cm Numerical Pain Rating Scale(NPRS; 0: no pain, 10: maximum pain) will be used to assess current level of hand pain, and worst level of hand pain experienced in the preceding week.
次要结局
- Changes in patients self-perceived improvement between baseline and follow-up periods(Baseline and 1, 3, 6 and 12 months after the intervention)
- Changes in function between baseline and follow-up periods(Baseline, and 1, 3, 6 and 12 months after intervention)
- Changes in severity of the symptoms between baseline and follow-up periods(Baseline, and 1, 3, 6 and 12 months after the intervention)
研究者
César Fernández-de-las-Peñas
Professor
Universidad Rey Juan Carlos