- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07545161
Pulsed US Versus SWD in Carpal Tunnel Syndrome
Pulsed Ultrasound Versus Pulsed Shortwave Diathermy in Mild-to-Moderate Carpal Tunnel Syndrome: A Randomized Controlled Trial
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy of the upper extremity and is characterized by pain, numbness, and hand weakness. Conservative treatment is recommended as first-line therapy in patients with mild-to-moderate CTS and commonly includes wrist splinting and nerve and tendon gliding exercises. Physical therapy modalities are frequently added to improve clinical outcomes.
This randomized, assessor-blinded, parallel-group clinical trial was conducted between March 2025 and Sep 2025. Forty participants with electrophysiologically confirmed mild-to-moderate CTS were randomly assigned to one of two intervention groups. All participants received standard conservative treatment consisting of neutral-position wrist splinting and tendon-nerve gliding exercises for three weeks.
In addition to standard treatment, one group received pulsed therapeutic ultrasound (US) and the other group received pulsed shortwave diathermy (SWD), administered in 15 sessions over three weeks.
Outcome measures were assessed at baseline, 1 month, and 3 months. The primary outcome was the change in median nerve cross-sectional area measured by ultrasonography at 3 months. Secondary outcomes included symptom severity and functional status assessed by the Boston Carpal Tunnel Questionnaire (BCTQ), pain intensity measured by the Visual Analog Scale (VAS), neuropathic pain assessed using the DN4 questionnaire, and hand grip strength measured with a dynamometer.
The study was designed to compare the clinical and structural effects of pulsed US and pulsed SWD when added to standard conservative treatment in mild-to-moderate CTS.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kahramanmaraş, Turkey (Türkiye)
- Kahramanmaraş Sütçü İmam University
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Kahramanmaraş, Turkey (Türkiye), 46000
- Kahramanmaraş Sütçü İmam University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age between 18 and 65 years
- Symptom duration of at least 4 weeks
- Diagnosis of mild-to-moderate carpal tunnel syndrome confirmed by electromyography
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Ultrasound Therapy Group
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.
|
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.
|
|
Active Comparator: Short Wave Diathermy Group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Median Nerve Cross-Sectional Area (MNCSA)
Time Frame: Baseline and 3 months
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Change in ultrasonographically measured median nerve cross-sectional area (mm²) from baseline to 3 months after treatment.
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Baseline and 3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Boston Carpal Tunnel Questionnaire Score
Time Frame: Baseline, 1 month, and 3 months
|
Change in Boston Carpal Tunnel Questionnaire total score (including Symptom Severity and Functional Status subscales) from baseline to 1 month and 3 months after treatment.
Higher scores indicate worse symptom severity and functional impairment.
|
Baseline, 1 month, and 3 months
|
|
Change in Pain Intensity (VAS)
Time Frame: Baseline, 1 month, and 3 months
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Change in pain intensity measured by a 10-cm VAS, where 0 indicates no pain and 10 indicates worst imaginable pain, from baseline to 1 month and 3 months.
|
Baseline, 1 month, and 3 months
|
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Change in Neuropathic Pain Score (DN4)
Time Frame: Baseline, 1 month, and 3 months
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Change in neuropathic pain severity measured by the DN4 questionnaire (0-10 scale), from baseline to 1 month and 3 months.
Higher scores indicate greater neuropathic pain severity.
|
Baseline, 1 month, and 3 months
|
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Change in Grip Strength
Time Frame: Baseline, 1 month, and 3 months
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Change in hand grip strength measured using a hydraulic hand dynamometer (kg), from baseline to 1 month and 3 months.
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Baseline, 1 month, and 3 months
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Wounds and Injuries
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Body Temperature Changes
- Median Neuropathy
- Mononeuropathies
- Nerve Compression Syndromes
- Cumulative Trauma Disorders
- Sprains and Strains
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Carpal Tunnel Syndrome
- Fever
Other Study ID Numbers
- BKA-2025-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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