Impact of a Conservative Treatment in the Waiting List for Carpal Tunnel Syndrome Surgery: Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Change in paresthesia intensity (VAS)
研究概览
简要总结
STC is considered one of the most prevalent peripheral neuropathy of the upper quadrant. Systematic review shows that conservative treatment is effective for treatment of CTS. In Spain, most patients diagnosed by CTS are included in surgery list without considering conservative treatment as first option or providing drugs or night splint . However, surgical treatment is not always necessary for these patients, and waiting list delays can lead to aggravation of patients' symptoms.
Researches believe that performing a conservative treatment including diacutaneous fibrolysis on carpal tunnel syndrome patients, could reduce waiting surgery list, reduce the cost-effectiveness rate of the surgical process and improve patient's satisfaction and clinical findings. In addition, patients of any level of severity and with systemic pathology will be included to define which patients would benefit from surgical treatment and which from physiotherapeutic treatment.
The aim is to find out the impact of a multimodal physiotherapy treatment in patients with Carpal Tunnel Syndrome (CTS) on the patient and the Aragonese Health System.
A randomized controlled clinical trial will be performed. First a pilot study will be carried out. Patients with carpal tunnel syndrome included on waiting surgery list of Miguel Servet Hospital will be recruited. They will be randomized into a control group (staying in waiting list and performing healthcare standard) and into an experimental group (3 sessions of 45 min of diacutaneous fibrolysis and homebased treatment). Different outcomes will be assessed at pre-treatment, at the end of treatment, 3 and 6 months later.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in paresthesia intensity (VAS)
时间窗: Change between baseline, immediate before and after each session, post-treatment, 3 months after, 6 months after
The Visual Analog Scale is a unidimensional measure of symptoms intensity. Is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (paresthesia) orientated from the left (worst) to the right (best). Paresthesia was measured in the last 3 days and currently.
Change in pain intensity (VAS)
时间窗: Change between baseline, immediate before and after each session, post-treatment, 3 months after, 6 months after
The Visual Analog Scale is a unidimensional measure of symptoms intensity. Is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (pain) orientated from the left (worst) to the right (best). Pain was measured in the last 3 days and currently.
Change in nocturnal symptoms intensity (VAS)
时间窗: Change between baseline, post-treatment, 3 months after, 6 months after
The Visual Analog Scale is a unidimensional measure of symptoms intensity. Is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (nocturnal symptoms) orientated from the left (worst) to the right (best). Nocturnal sumptoms were measured in the last 3 days.
Change in BCTQ
时间窗: Change between baseline, post-treatment, 3 months after, 6 months after
The Boston Carpal Tunnel Questionnaire (BCTQ) is a disease-specific measure of self-reported symptom severity and functional status. It is frequently used in the reporting of outcomes from trials into interventions for carpal tunnel syndrome.
Change in DASH questionnaire
时间窗: Change between baseline, post-treatment, 3 months after, 6 months after
The disabilities of the arm, shoulder and hand (DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100.
次要结局
- Change in Katz's Diagram(Change between baseline, post-treatment, 3 months after, 6 months after)
- Change in NRS(The Numeric Rating Scale is a one-dimensional measure of symptoms intensity in adults. In our study, it was used to quantify the intensity of other symptoms present. It is a segmented numeric version of the visual analog scale (VAS) in which a respondent)
- Change in MOS Sleep Scale(Change between baseline, post-treatment, 3 months after, 6 months after)
- Change in TSK(Change between baseline, post-treatment, 3 months after, 6 months after)
- Change in ULTT(Change between baseline, immediate before and after each session, post-treatment, 3 months after, 6 months after)
- Change in SF-36(Change between baseline, post-treatment, 3 months after, 6 months after)
- Change in PGI-I(Change between post-treatment, 3 months after, 6 months after)
- Change in Strength(Change between baseline, post-treatment, 3 months after, 6 months after)
- Change in SWMT(Change between baseline, immediate before and after each session, post-treatment, 3 months after, 6 months after)
- Change in Neuropen(Change between baseline, post-treatment, 3 months after, 6 months after)
研究者
Mar Hernández Secorún
Teaching Assistant and PhD student
Universidad de Zaragoza