Comparison of Interventions in Patients With Carpal Tunnel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Change from baseline Visual analog scale at eight weeks
研究概览
简要总结
This study aims to compare two types of intervention (stretching and myofascial manipulation) in the treatment of individuals with bilateral idiopathic carpal tunnel syndrome. This comparison applies to two groups, the clinical group is composed of patients of mild or moderate degree, whereas the surgical group is composed of a patient with at least one hand in severe degree and interventions are made after surgery.
详细描述
Using clinical criteria and ENMG, individuals will be divided into a clinical group when they have a mild and / or moderate degree of involvement in the hands and a surgical group when the impairment intensity is severe in at least one hand.
The individuals in the clinical group will be randomized into two groups, with one group starting with stretching and a second group starting with hook-assisted myofascial manipulation. After four weeks of initial therapy and one week of wash-out the assessment tests described above will be applied. The groups will be inverted, maintaining the duration and frequency of the previous stage of the proposed therapies. After four weeks with a week of wash-out the tests will be reapplied in order to evaluate the therapeutic response.
Individuals with severe idiopathic CTS will undergo surgery using a standard open technique with local anesthesia and after four weeks, randomization will be made for postoperative treatment on both hands by stretching or myofascial manipulation in the same manner described for the clinical group.
Questionnaires will be applied in order to understand the patient's symptoms, functions, pain and quality of life. In addition, tests will be used to assess hand strength, sensitivity and hand ability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •bilateral idiopathic CTS above six months of symptomatology;
- •with clinical criteria and ENMG for indication of clinical or surgical treatment;
- •who have no history of gabapentin allergy.
排除标准
- •Individuals with CTS for other reasons, such as pregnancy, arthritis, hypothyroidism, diabetes mellitus, trauma, expansive tunnel damage, amyloids, sarcoidosis, multiple myeloma, and leukemia.
- •Individuals with conditions that can simulate CTS, such as carpometacarpal thumb arthritis, cervical radiculopathy mainly of the sixth cervical root level, radial flexor carpal tenosynovitis and central disorders such as multiple sclerosis and cerebral infarction.
结局指标
主要结局
Change from baseline Visual analog scale at eight weeks
时间窗: Change from baseline at 8 weeks
The visual analog scale will measure the patient's pain intensity. The scale goes from 0 to 10, with 10 being better.
Change from baseline Boston Questionnarie score at eight weeks
时间窗: Change from baseline at 8 weeks
The Boston questionnaire assesses the symptoms and functions of patients with CTS, it is self-administered. The sensitivity scale goes from 11 to 55, the motor scale goes from 7 to 35, bigger is better.
次要结局
- Change from baseline Hand strength test at eight weeks(Change from baseline at 8 weeks.)
- Change from baseline Short-Form 6 Dimensions at eight weeks(Change from baseline at 8 weeks)
- Change from baseline Sensitivity tests at eigth weeks(Change from baseline at 8 weeks)
- Change from baseline Manual skill score at eigth weeks(Change from baseline at 8 weeks)
- 3D Assessment of Hand Function for the right and left hand.(Day 0)
- Change from baseline Brief Michigan Hand Questionnaire for the right and left hand at eight weeks.(Change from baseline at 8 weeks)