Carpal Tunnel SyndromeNCT07545161
Pulsed US Versus SWD in Carpal Tunnel Syndrome
A study testing Pulsed Therapeutic Ultrasound and Pulsed Shortwave Diathermy in people with Carpal Tunnel Syndrome and Physical Therapy Modalities, run by Kahramanmaras Sutcu Imam University at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Carpal Tunnel Syndrome, Physical Therapy Modalities, Ultrasound Therapy
- What is being tested?
- Pulsed Therapeutic Ultrasound and Pulsed Shortwave Diathermy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 11 Mar 2025to 15 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years
- Symptom duration of at least 4 weeks
- Diagnosis of mild-to-moderate carpal tunnel syndrome confirmed by electromyography
Who cannot join
- Cervical radiculopathy
- Brachial plexopathy
- Thoracic outlet syndrome
- Previous carpal tunnel surgery
- Severe carpal tunnel syndrome
- Pregnancy
Show all 10Show fewer
- Malignancy
- Coagulation disorders
- Cardiac pacemaker
- Physical therapy for carpal tunnel syndrome within the previous 6 months
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Kahramanmaras Sutcu Imam University
Kahramanmaraş, 46000
Kahramanmaras Sutcu Imam University
Kahramanmaraş
About this study
Official title: 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:
Read more
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.
Read the 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.
- Being tested
- Pulsed Therapeutic Ultrasound, Pulsed Shortwave Diathermy
- Keywords
- Carpal tunnel syndrome, ultrasonography, diathermy, median nerve, randomized controlled trial
- Medical subject headings
- Carpal Tunnel Syndrome, Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed Therapeutic UltrasoundDevice
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 DiathermyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Pulsed Shortwave Diathermy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 3 months
Secondary outcomes (4)
Change in Boston Carpal Tunnel Questionnaire Score
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.
Measured: Baseline, 1 month, and 3 months
Change in Pain Intensity (VAS)
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.
Measured: Baseline, 1 month, and 3 months
Change in Neuropathic Pain Score (DN4)
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.
Measured: Baseline, 1 month, and 3 months
Change in Grip Strength
Change in hand grip strength measured using a hydraulic hand dynamometer (kg), from baseline to 1 month and 3 months.
Measured: Baseline, 1 month, and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start11 Mar 2025
- Primary completion15 Aug 2025
- Study completion15 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MD.Bilgehan Kolutek Ay, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07545161
- Sponsor's protocol ID
- BKA-2025-1
- Status last verified
- Apr 2026
- First submitted
- 16 Apr 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to institutional data protection policies and privacy considerations.
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulsed Ultrasound Versus Pulsed Shortwave Diathermy in Mild-to-Moderate Carpal Tunnel Syndrome: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07545161
- Acronym / sponsor ID
- BKA-2025-1
- Keywords
- Carpal tunnel syndrome, ultrasonography, diathermy, median nerve, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 11 Mar 2025 (actual)
- Primary completion
- 15 Aug 2025 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 22 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Ultrasound Therapy Group | Active comparator | Device: Pulsed Therapeutic UltrasoundParticipants in this group received pulsed therapeutic ultrasound in addition to standard conservative treatment, including wrist splinting and tendon-nerve gliding exercises for three weeks. |
| Short Wave Diathermy Group | Active comparator | Device: Pulsed Shortwave DiathermyParticipants in this group received pulsed shortwave diathermy in addition to standard conservative treatment, including wrist splinting and tendon-nerve gliding exercises for three weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18 and 65 years
- Symptom duration of at least 4 weeks
- Diagnosis of mild-to-moderate carpal tunnel syndrome confirmed by electromyography
Key exclusion criteria (10 listed)
- Cervical radiculopathy
- Brachial plexopathy
- Thoracic outlet syndrome
- Previous carpal tunnel surgery
- Severe carpal tunnel syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulsed Therapeutic UltrasoundPulsed 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. | Device | Ultrasound Therapy Group |
| Pulsed Shortwave DiathermyPulsed 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. | Device | Short Wave Diathermy Group |
Primary outcome
Change in Median Nerve Cross-Sectional Area (MNCSA)
Time frame: Baseline and 3 months
Change in ultrasonographically measured median nerve cross-sectional area (mm²) from baseline to 3 months after treatment.
4 secondary outcomes
Change in Boston Carpal Tunnel Questionnaire Score
Time frame: Baseline, 1 month, and 3 months
Change in Pain Intensity (VAS)
Time frame: Baseline, 1 month, and 3 months
Change in Neuropathic Pain Score (DN4)
Time frame: Baseline, 1 month, and 3 months
Change in Grip Strength
Time frame: Baseline, 1 month, and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to institutional data protection policies and privacy considerations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed Therapeutic Ultrasound and Pulsed Shortwave Diathermy in people with Carpal Tunnel Syndrome and Physical Therapy Modalities, run by Kahramanmaras Sutcu Imam University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Median Nerve Cross-Sectional Area (MNCSA) (time frame: Baseline and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.