Pulsed US Versus SWD in Carpal Tunnel Syndrome

NCT07545161 | Completed

• 1 other identifier: BKA-2025-1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this clinical trial is to compare two physical therapy treatments in people with mild-to-moderate carpal tunnel syndrome (CTS). CTS is a condition that causes pain, numbness, and weakness in the hand. The main question this study aims to answer is: Does pulsed ultrasound or pulsed shortwave diathermy lead to greater improvement in symptoms and nerve swelling when added to standard treatment? All participants will receive standard conservative treatment, including a wrist splint and nerve and tendon gliding exercises for three weeks. In addition, participants will be randomly assigned to receive one of the following treatments: Pulsed therapeutic ultrasound (US) Pulsed shortwave diathermy (SWD) Researchers will measure changes in hand symptoms, pain levels, grip strength, and the size of the median nerve using ultrasound imaging. Assessments will be performed before treatment, and at 1 month and 3 months after treatment. The primary outcome of the study is the change in median nerve cross-sectional area at 3 months.

Conditions

Carpal Tunnel Syndrome; Physical Therapy Modalities; Ultrasound Therapy

Keywords

Carpal tunnel syndrome; ultrasonography; diathermy; median nerve; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Change in Median Nerve Cross-Sectional Area (MNCSA)

  Change in ultrasonographically measured median nerve cross-sectional area (mm²) from baseline to 3 months after treatment.

  Baseline and 3 months

Secondary Outcomes (4)

• Change in Boston Carpal Tunnel Questionnaire Score

  Baseline, 1 month, and 3 months

• Change in Pain Intensity (VAS)

  Baseline, 1 month, and 3 months

• Change in Neuropathic Pain Score (DN4)

  Baseline, 1 month, and 3 months

• Change in Grip Strength

  Baseline, 1 month, and 3 months

Study Arms (2)

Ultrasound Therapy Group

ACTIVE COMPARATOR

Participants in this group received pulsed therapeutic ultrasound in addition to standard conservative treatment, including wrist splinting and tendon-nerve gliding exercises for three weeks.

Device: Pulsed Therapeutic Ultrasound

Short Wave Diathermy Group

ACTIVE COMPARATOR

Participants in this group received pulsed shortwave diathermy in addition to standard conservative treatment, including wrist splinting and tendon-nerve gliding exercises for three weeks.

Device: Pulsed Shortwave Diathermy

Interventions

Pulsed Therapeutic Ultrasound DEVICE

Pulsed therapeutic ultrasound was applied to the volar aspect of the wrist using a frequency of 3 MHz, an intensity of 0.8 W/cm², and a pulse ratio of 1:4 for 5 minutes per session. A total of 15 treatment sessions were administered over three weeks.

Ultrasound Therapy Group

Pulsed Shortwave Diathermy DEVICE

Pulsed shortwave diathermy was applied with electrodes positioned parallel to the volar and dorsal aspects of the wrist, centered at the distal palmar crease. Treatment was delivered in pulsed mode at a frequency of 80 Hz and a mean output power of 19.2 W for 15 minutes per session. A total of 15 sessions were administered over three weeks.

Short Wave Diathermy Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 65 years
• Symptom duration of at least 4 weeks
• Diagnosis of mild-to-moderate carpal tunnel syndrome confirmed by electromyography

You may not qualify if:

• Cervical radiculopathy
• Brachial plexopathy
• Thoracic outlet syndrome
• Previous carpal tunnel surgery
• Severe carpal tunnel syndrome
• Pregnancy
• Malignancy
• Coagulation disorders
• Cardiac pacemaker
• Physical therapy for carpal tunnel syndrome within the previous 6 months

Sponsors & Collaborators

• Kahramanmaras Sutcu Imam University: lead

Study Sites (2)

Kahramanmaras Sutcu Imam University

Kahramanmaraş, 46000, Turkey (Türkiye)

Location

Kahramanmaras Sutcu Imam University

Kahramanmaraş, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Fever

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; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessments, including ultrasonographic measurements and clinical questionnaires, were performed by an assessor blinded to group allocation. Participants and treatment providers were not blinded due to the nature of the interventions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants were randomly assigned in a 1:1 ratio to one of two parallel treatment groups: pulsed therapeutic ultrasound or pulsed shortwave diathermy. Both groups received standard conservative treatment including wrist splinting and tendon-nerve gliding exercises. Outcome assessments were performed by an assessor blinded to group allocation.

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: April 22, 2026
• Study Start: March 11, 2025
• Primary Completion: August 15, 2025
• Study Completion: September 15, 2025
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)