Pregabalin Phonophoresis for Carpal Tunnel Syndrome Pain

NCT07613476 | Active Not Recruiting

• 1 other identifier: TUF/EIRB/ 198 /26
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Carpal Tunnel Syndrome (CTS)

Keywords

Phonophoresis; Neuropathic Pain; Ultrasound Therapy; Therapeutic ultrasound; Ultrasound assisted Drug delivery; Pregabalin gel; Physiotherapy modalities; Topical gel for neuropathic pain; Carpel tunnel syndrome

Outcome Measures

Primary Outcomes (1)

• Change in Pain Intensity as Measured by the Numeric Pain Rating Scale (NPRS)

  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 Outcomes (1)

• Change in Functional Status as Measured by the Boston Carpal Tunnel Questionnaire (BCTQ)

  Baseline and at Week 4 (immediately after the final treatment session)

Study Arms (2)

Pregabalin Phonophoresis Group

EXPERIMENTAL

Participants receive phonophoresis using a pregabalin-based gel combined with therapeutic ultrasound.

Other: Pregabalin Phonophoresis

Conventional Ultrasound Group

ACTIVE COMPARATOR

Participants receive therapeutic ultrasound using a standard, non-medicated coupling gel.

Device: Therapeutic Ultrasound

Interventions

Pregabalin Phonophoresis OTHER

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.

Pregabalin Phonophoresis Group

Therapeutic Ultrasound DEVICE

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.

Conventional Ultrasound Group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Faisalabad: lead

Study Sites (1)

The University of Faisalabad

Faisalābad, Punjab Province, 3800, Pakistan

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Neuralgia

Interventions

Ultrasonic Therapy

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diathermy; Hyperthermia, Induced; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Rehabilitation Sciences

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: May 29, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): July 19, 2026
• Study Completion (Estimated): July 19, 2026
• Last Updated: June 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)