Pregabalin Phonophoresis for Carpal Tunnel Syndrome Pain (PREG-CTS-USG)
2026年6月4日 更新者：Muhammad Muneeb Jafar、University of Faisalabad
Effect of Pregabalin Phonophoresis Therapy on Pain and Functional Outcomes in Patients With Carpal Tunnel Syndrome: A Randomized Controlled Trial
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
30
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Punjab Province
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Faisalābad、Punjab Province、巴基斯坦、3800
- The University of Faisalabad
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
接受健康志愿者
不
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Pregabalin Phonophoresis Group
Participants receive phonophoresis using a pregabalin-based gel combined with therapeutic ultrasound.
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A topical gel containing pregabalin is applied to the volar aspect of the wrist over the carpal tunnel.
A therapeutic ultrasound head (1 MHz, 1.5 W/cm^²) is then moved in a circular motion over the gel for a total of 5 minutes per session.
The ultrasound facilitates the transdermal delivery of pregabalin.
This is administered 4 times per week for 4 weeks.
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有源比较器：Conventional Ultrasound Group
Participants receive therapeutic ultrasound using a standard, non-medicated coupling gel.
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Standard ultrasonic coupling gel is applied to the volar aspect of the wrist over the carpal tunnel.
A therapeutic ultrasound head (1 MHz, 1.5 W/cm^²) is then moved in a circular motion over the gel for a total of 5 minutes per session.
This is administered 4 times per week for 4 weeks.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Pain Intensity as Measured by the Numeric Pain Rating Scale (NPRS)
大体时间：Baseline and at Week 4 (immediately after the final treatment session)
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The Numeric Pain Rating Scale (NPRS) is an 11-point scale ranging from 0 (no pain) to 10 (worst imaginable pain).
Participants will self-report their current level of pain.
A higher score indicates worse pain.
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Baseline and at Week 4 (immediately after the final treatment session)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Functional Status as Measured by the Boston Carpal Tunnel Questionnaire (BCTQ)
大体时间：Baseline and at Week 4 (immediately after the final treatment session)
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The Boston Carpal Tunnel Questionnaire (BCTQ) is a disease-specific, patient-reported outcome measure.
It consists of the Symptom Severity Scale (11 questions, each scored 1-5) and the Functional Status Scale (8 questions, each scored 1-5).
The final score for each scale is the mean of the answers, ranging from 1 (best) to 5 (worst).
A higher score indicates greater disability.
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Baseline and at Week 4 (immediately after the final treatment session)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年1月1日
初级完成 (估计的)
2026年7月19日
研究完成 (估计的)
2026年7月19日
研究注册日期
首次提交
2026年5月21日
首先提交符合 QC 标准的
2026年5月21日
首次发布 (实际的)
2026年5月29日
研究记录更新
最后更新发布 (实际的)
2026年6月8日
上次提交的符合 QC 标准的更新
2026年6月4日
最后验证
2026年5月1日
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- TUF/EIRB/ 198 /26
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
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