The Effects of Thermal and Pulsed Ultrasound on Pain and Function in Individuals With Carpal Tunnel Syndrome: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- Functional Status
研究概览
简要总结
This study will be a Randomized controlled trial with a sample size of at least 100 individuals with carpal tunnel syndrome. Participants will be randomized to receive either thermal ultrasound, pulsed ultrasound, a combination of both, or a placebo treatment for 10 minutes, three times per week, for 4 weeks. Outcome measures will include pain intensity, functional status, and nerve conduction studies. Outcome measures will be assessed at baseline, 4 weeks, and 8 weeks.
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
- Double (Participant, Outcomes Assessor)
盲法说明
In addition to the participants being blinded to the treatment they are receiving, the outcome assessors will also be blinded to the treatment assignment. This will ensure that the assessors are unbiased when measuring the outcome measures of pain intensity, functional status, and nerve conduction studies.
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
- •Adults aged 30-60 years old
- •Diagnosis of carpal tunnel syndrome based on clinical symptoms and nerve conduction studies, including:
- •Symptoms of pain, numbness, and tingling in the hand and/or fingers, particularly the thumb, index, and middle fingers
- •Positive Tinel's sign (tapping over the median nerve at the wrist elicits tingling or numbness in the hand)
- •Positive Phalen's maneuver (flexion of the wrist for 60 seconds elicits tingling or numbness in the hand)
- •Abnormal nerve conduction studies showing prolonged distal motor latency, and/or decreased amplitude of the median nerve
排除标准
- •Prior surgery for carpal tunnel syndrome
- •History of wrist or hand fracture in the past year
- •Pregnancy or planning to become pregnant during the study period
- •Active infection or skin condition in the treatment area
- •Known allergy to ultrasound gel or other components of the treatment
- •Use of corticosteroids or other medications that may affect nerve function within the past 3 months
- •Participation in another clinical trial within the past 30 days
结局指标
主要结局
Functional Status
时间窗: Changes in functional status at baseline, 4 weeks after randomization, and 8 weeks after discharge.
his will be measured using the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire, which is a validated instrument for assessing upper extremity function. The DASH consists of 30 items assessing physical function, symptoms, and social-emotional aspects of disability, and scores range from 0 (no disability) to 100 (severe disability).
Pain Intensity
时间窗: Changes in pain intensity at baseline, 4 weeks after randomization, and 8 weeks after discharge.
This will be measured using the visual analogue scale (VAS), which is a valid and reliable tool for assessing pain intensity. The VAS is a 10-cm horizontal line with anchors of "no pain" and "worst pain imaginable," and participants will be asked to mark their level of pain intensity on the line.
次要结局
- Hand grip strength(Changes in hand grip strength at baseline, 4 weeks after randomization, and 8 weeks after discharge.)
- Nerve Conduction Studies(Changes in nerve conduction studies at baseline, 4 weeks after randomization, and 8 weeks after discharge.)
研究者
Mohamed Magdy ElMeligie
Lecturer of Physical Therapy and Director of Electromyography Lab
Ahram Canadian University