NCT Number: NCT07545161
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.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Kahramanmaras Sutcu Imam University, Kahramanmaraş, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Baseline and 3 months
Change in ultrasonographically measured median nerve cross-sectional area (mm²) from baseline to 3 months after treatment.
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.
Time frame: Baseline, 1 month, and 3 months
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.
Time frame: Baseline, 1 month, and 3 months
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.
Time frame: Baseline, 1 month, and 3 months
Change in hand grip strength measured using a hydraulic hand dynamometer (kg), from baseline to 1 month and 3 months.
Kahramanmaras Sutcu Imam University
Other
Pulsed Ultrasound Versus Pulsed Shortwave Diathermy in Mild-to-Moderate Carpal Tunnel Syndrome: A Randomized Controlled Trial
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