Pregabalin Phonophoresis for Carpal Tunnel Syndrome Pain

May 21, 2026 updated by: 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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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/cm² 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 Numeric Pain Rating Scale (NPRS) and the Boston Carpal Tunnel Questionnaire (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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab Province
      • Faisalābad, Punjab Province, Pakistan, 3800
        • The University of Faisalabad

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Clinical diagnosis of Carpal Tunnel Syndrome confirmed by positive Phalen's maneuver or Tinel's sign
  • Age between 20 and 40 years
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pregabalin Phonophoresis Group
Participants receive phonophoresis using a pregabalin-based gel combined with therapeutic ultrasound.
Other: Pregabalin Phonophoresis
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/cm²) 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.
Active Comparator: Conventional Ultrasound Group
Participants receive therapeutic ultrasound using a standard, non-medicated coupling gel.
Device: Therapeutic Ultrasound
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/cm²) 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pain Intensity as Measured by the Numeric Pain Rating Scale (NPRS)
Time Frame: Baseline and at Week 4 (immediately after the final treatment session)
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.
Baseline and at Week 4 (immediately after the final treatment session)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Functional Status as Measured by the Boston Carpal Tunnel Questionnaire (BCTQ)
Time Frame: Baseline and at Week 4 (immediately after the final treatment session)
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.
Baseline and at Week 4 (immediately after the final treatment session)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Faisalabad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2026

Primary Completion (Estimated)

July 19, 2026

Study Completion (Estimated)

July 19, 2026

Study Registration Dates

First Submitted

May 21, 2026

First Submitted That Met QC Criteria

May 21, 2026

First Posted (Actual)

May 29, 2026

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TUF/EIRB/ 198 /26

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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