Effect of Pregabalin Phonophoresis Therapy on Pain and Functional Outcomes in Patients With Carpal Tunnel Syndrome: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
Carpal tunnel syndrome (CTS) is a common condition caused by pressure on the median nerve in the wrist, leading to pain, numbness, and weakness in the hand. Oral medications for nerve pain can have significant side effects. This study tests a new, non-invasive approach. Pregabalin, a medication for neuropathic pain, will be mixed into a gel and delivered through the skin using therapeutic ultrasound, a method called phonophoresis. This avoids the digestive system and may reduce side effects. This randomized controlled trial will compare the effects of pregabalin phonophoresis against standard ultrasound therapy (without the drug) in 57 patients aged 20-40 with mild to moderate CTS. Treatments will occur 4 times per week for one month. Pain will be measured using the Numeric Pain Rating Scale, and hand function using the Boston Carpal Tunnel Questionnaire. The study aims to determine if pregabalin phonophoresis provides superior pain relief and functional improvement compared to ultrasound alone, offering a new, safe, and cost-effective physiotherapy treatment for CTS.
详细描述
This is a multi-center, prospective, randomized, active-controlled, parallel-group trial. After providing informed consent and meeting the inclusion criteria (positive Phalen's/Tinel's sign, symptom duration >3 months, age 20-40), participants will be randomized into two groups using a random number generator. Group A (Experimental) will receive pregabalin phonophoresis. A pregabalin gel will be applied to the affected wrist, followed by therapeutic ultrasound at 1 MHz frequency, 1.5 W/cm^² intensity in circular motion for 5 minutes. Group B (Active Comparator) will receive the same ultrasound parameters applied with a plain, non-medicated gel. Treatment for both groups will be administered 4 sessions per week for 4 consecutive weeks (total 16 sessions). Outcome measures, including the NPRS and the BCTSQ, will be collected at baseline and after the final treatment session at week 4. Data will be analyzed using SPSS version 22.0, with an intention-to-treat analysis. A p-value <0.05 will be considered statistically significant. The trial will be conducted at Madinah Teaching Hospital and Jafar Physiotherapy Center in Faisalabad, Pakistan.
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
The patient won't know if the gel contains the drug. The person measuring the final NRS and BCTSQ scores won't know which group the patient was in. The physician applying the treatment will know, but that's unavoidable.
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Carpal Tunnel Syndrome confirmed by positive Phalen's maneuver or Tinel's sign
- •Age between 20 and 40 years with no painkillers for more than a week
- •Symptom duration of more than 3 months
- •Mild to moderate CTS (no thenar muscle atrophy)
- •Willing to provide written informed consent
排除标准
- •History of steroid injection for CTS in the past 3 months
- •Prior surgery for Carpal Tunnel Syndrome
- •Currently pregnant or breastfeeding
- •Malignancy or any contraindication to ultrasound (e.g., acute infection, bleeding disorder over the wrist)
- •Presence of cervical radiculopathy
- •Previous wrist fracture on the affected side
- •Participation in another interventional trial
研究者
Muhammad Muneeb Jafar
Assistant Professor, Department of Rehabilitation Sciences
University of Faisalabad