Randomized Controlled Trial Comparing the Effectiveness of Stretching and Orthoses Versus Orthoses Alone in Individuals With Carpal Tunnel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Boston Carpal Tunnel Questionnaire (BCTQ)
研究概览
简要总结
The objective of this study is to compare the effectiveness of stretching and prefabricated orthoses versus orthoses alone in individuals with carpal tunnel syndrome (CTS) using validated condition-appropriate outcome measures such as BCTQ, pain levels, grip strength, and nerve conduction studies.
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)
盲法说明
Participants and care providers will not be blinded to the treatment group, but outcomes assessors will be blinded to the treatment group.
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 30-60 years or older with a confirmed diagnosis of carpal tunnel syndrome based on clinical presentation and/or nerve conduction studies.
- •Participants must have a moderate level of symptom severity, defined as a score of 2 or greater on the symptom severity subscale of the Boston Carpal Tunnel Questionnaire (BCTQ).
- •Participants must have a moderate level of functional impairment, defined as a score of 2 or greater on the functional status subscale of the BCTQ.
- •Participants must be willing and able to provide informed consent to participate in the study.
排除标准
- •Participants with a history of hand or wrist surgery within the past 6 months, as this could impact hand function and confound the study results.
- •Participants with severe hand or wrist pain that would prevent completion of the outcome measures or interfere with their ability to participate in the study.
- •Participants with severe cognitive impairment or language barrier that would prevent understanding of the study instructions or interfere with their ability to participate in the study.
- •Participants with any other medical condition that could affect hand function or interfere with test completion, such as rheumatoid arthritis, osteoarthritis, or peripheral neuropathy.
- •Participants who have participated in any other clinical trial or research study involving the hand or wrist within the past 3 months, as this could impact hand function and confound the study results.
- •Participants who are unable to comply with study procedures or follow-up requirements, such as attending scheduled study visits or completing study questionnaires.
结局指标
主要结局
Boston Carpal Tunnel Questionnaire (BCTQ)
时间窗: Changes in BCTQ at baseline, 8 weeks, and 16 weeks.
The BCTQ is a validated condition-specific questionnaire used to assess the severity of symptoms and functional limitations associated with carpal tunnel syndrome. The questionnaire consists of 11 items related to symptom severity and 8 items related to functional status. The scores for each set of items are combined to generate symptom severity and functional status scores, which will be used as the primary outcome measures for this study.
Pain Levels
时间窗: Changes in pain level at baseline, 8 weeks, and 16 weeks.
Pain levels will be assessed using a visual analogue scale (VAS) ranging from 0 (no pain) to 10 (worst pain imaginable). Participants will be asked to rate their pain levels at rest and during specific activities such as gripping, pinching, and typing.
次要结局
- Grip Strength(Changes in grip strength at baseline, 8 weeks, and 16 weeks.)
- Nerve Conduction Studies(Changes in nerve conduction studies at baseline, 8 weeks, and 16 weeks.)
研究者
Mohamed Magdy ElMeligie
Lecturer of Physical Therapy and Director of Electromyography Lab
Ahram Canadian University