Evaluation of Fascial Manipulation for the Conservative Treatment of Carpal Tunnel Syndrome: Double Blind Randomized Clinical Trial, Phase II
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Change from baseline in pain on the VAS score for pain at 10 days after the end of the treatment.
研究概览
简要总结
The trial aims to evaluate the effectiveness of Fascial Manipulation on pain reduction, functional recovery and nerve conduction of patients with Carpal Tunnel Syndrome (CTS). Visual Analogue Scale (VAS), Disabilities of the Arm, Shoulder and Hand scale (DASH), Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) and Electroneuromyography were assessed.
The study is blind for the patient and the raters.
详细描述
This is a prospective, randomized, placebo controlled, rater blind trial to evaluate the effectiveness of Fascial Manipulation as a therapy for CTS. Fascial Manipulation is an intense friction performed by the elbows or the distal extremities of the interphalangeal articulation of the index finger for some minutes as to promote hyperemia to restore the collagen fibers ability to slide against each other. The friction lasts from 2 to 4 minutes.
In this trial, 14 patients were randomized in two groups: The intervention group received fascial manipulation for CTS and the other group, received fascial manipulation on spots not related to CTS. This last group was the placebo control group.
The treatment was performed once a week for 5 weeks consecutively and the follow up visits for the assessments were performed 10 days and 3 months after the end of the treatment.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CTS degrees Ia, Ib and II diagnosis according to clinical evaluation and electroneuromyography;
- •Wrist and finger paresthesia for more than 3 months prior to screening visit;
- •Moderate to intense pain: VAS>
- •Ability to understand and respond to the questionnaires used in the trial;
- •Ability to understand the Informed Consent Form;
- •Sign the Informed Consent Form.
排除标准
- •Psychiatric disorders;
- •Fibromyalgia;
- •Rheumatologic diseases;
- •Other conditions related to CTS, as renal failure, diabetes, acromegaly, hyperthyroidism, multiple myeloma;
- •History of neoplasia;
- •History of surgery at Carpal Tunnel;
- •History of use of illegal drugs;
- •History of chronic use of corticosteroids;
- •Corticosteroid infiltration one month prior to inclusion in the trial.
研究组 & 干预措施
Treatment Fascial Manipulation
Seven patients with diagnosis of CTS, received five sessions of Fascial Manipulation performed by a physiotherapist. The sessions were performed once a week, and each session were 30 to 45 minutes long as to cover different painful spots.
干预措施: Fascial Manipulation (Procedure)
Placebo Fascial Manipulation
Seven patients with diagnosis of CTS, received five sessions of Sham Fascial Manipulation performed by a physiotherapist. The sessions were performed once a week, and each session were 30 to 45 minutes long as to cover different painful spots.
干预措施: Sham Fascial Manipulation (Procedure)
结局指标
主要结局
Change from baseline in pain on the VAS score for pain at 10 days after the end of the treatment.
时间窗: Baseline and 10 days after end of the treatment.
次要结局
- Change from baseline in pain on the VAS score for pain at 3 months after the end of the treatment.(Baseline and 3 months after end of the treatment.)
- Change from baseline in function on BCTQ score for function at 10 days and 3 months after the end of the treatment.(Baseline, 10 days and 3 months after the treatment)
- Change from baseline in function on DASH score for function at 10 days and 3(Baseline, 10 days and 3 months after the treatment)
- Change from baseline in nerve conduction on Electroneuromyography test for nerve conduction at 10 days after the end of the treatment(Baseline and 10 days after the treatment)
研究者
Marta Imamura
Coordinator of the Clinical Trial Site of the Institute of Physical Medicine and Rehabilitation Medicine of HCFMUSP
University of Sao Paulo