Thermal and Pulsed Ultrasound for Carpal Tunnel Syndrome

Study Overview
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Brief Summary
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This study will be a Randomized controlled trial with a sample size of at least 100 individuals with carpal tunnel syndrome. Participants will be randomized to receive either thermal ultrasound, pulsed ultrasound, a combination of both, or a placebo treatment for 10 minutes, three times per week, for 4 weeks. Outcome measures will include pain intensity, functional status, and nerve conduction studies. Outcome measures will be assessed at baseline, 4 weeks, and 8 weeks.

Official Title
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The Effects of Thermal and Pulsed Ultrasound on Pain and Function in Individuals With Carpal Tunnel Syndrome: A Randomized Controlled Trial

Conditions
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Carpal Tunnel Syndrome, Median Neuropathy, Carpal Tunnel

Intervention / Treatment
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* Device: Thermal Ultrasound
* Device: Pulsed Ultrasound
* Device: Combined Ultrasound
* Device: Placebo Ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults aged 30-60 years old Diagnosis of carpal tunnel syndrome based on clinical symptoms and nerve conduction studies, including: Symptoms of pain, numbness, and tingling in the hand and/or fingers, particularly the thumb, index, and middle fingers Positive Tinel's sign (tapping over the median nerve at the wrist elicits tingling or numbness in the hand) Positive Phalen's maneuver (flexion of the wrist for 60 seconds elicits tingling or numbness in the hand) Abnormal nerve conduction studies showing prolonged distal motor latency, and/or decreased amplitude of the median nerve Exclusion Criteria: Prior surgery for carpal tunnel syndrome History of wrist or hand fracture in the past year Pregnancy or planning to become pregnant during the study period Active infection or skin condition in the treatment area Known allergy to ultrasound gel or other components of the treatment Use of corticosteroids or other medications that may affect nerve function within the past 3 months Participation in another clinical trial within the past 30 days

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study will be a level II randomized controlled trial with a parallel group design. Participants will be randomized to receive one of four interventions: thermal ultrasound, pulsed ultrasound, a combination of both, or a placebo treatment. Participants will receive their assigned treatment for 10 minutes, three times per week, for 4 weeks.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A: Thermal Ultrasound Group<br> | Device: Thermal Ultrasound<br>* Participants in this group will receive thermal ultrasound treatment using a gel-coupled ultrasound probe that delivers continuous ultrasound waves at a frequency of 1 Mega Hertz. The ultrasound probe will be moved continuously over the affected wrist and hand region for 5 minutes per session, three times per week, for four weeks. The intensity of the ultrasound wave will be set at 1.0 W/cm2 applied for 5 minutes. The treatment will be administered three times per week, for four weeks.<br>|
| Experimental: Group B: Pulsed Ultrasound Group:<br> | Device: Pulsed Ultrasound<br>* Participants in this group will receive pulsed ultrasound treatment using a gel-coupled ultrasound probe that delivers pulsed ultrasound waves at a frequency of 1 Mega Hertz. The ultrasound probe will be moved continuously over the affected wrist and hand region for 15 minutes with 25% duty cycle and intensity of 1.0 W/cm2.The treatment will be administered three times per week, for four weeks.<br>|
| Experimental: Group C: Combination Group<br> | Device: Combined Ultrasound<br>* Participants in this group will receive a combination of thermal and pulsed ultrasound treatments. The thermal ultrasound treatment will be administered first for 5 minutes, followed by the pulsed ultrasound treatment for another 15 minutes. The same parameters as described above will be used for each treatment modality. The combination treatment will be administered three times per week, for four weeks.<br>|
| Placebo Comparator: Group D: Placebo Group<br> | Device: Placebo Ultrasound<br>* Participants in this group will receive a placebo ultrasound treatment that looks and feels identical to the active ultrasound treatments, but does not deliver any therapeutic effects. The placebo treatment will be administered using the same gel-coupled ultrasound probe for 15 minutes per session, three times per week, for four weeks, with the intensity set at 0 W/cm² and the temperature maintained at room temperature.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Intensity | This will be measured using the visual analogue scale (VAS), which is a valid and reliable tool for assessing pain intensity. The VAS is a 10-cm horizontal line with anchors of no pain and worst pain imaginable, and participants will be asked to mark their level of pain intensity on the line. | Changes in pain intensity at baseline, 4 weeks after randomization, and 8 weeks after discharge. | 
| Functional Status | his will be measured using the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire, which is a validated instrument for assessing upper extremity function. The DASH consists of 30 items assessing physical function, symptoms, and social-emotional aspects of disability, and scores range from 0 (no disability) to 100 (severe disability). | Changes in functional status at baseline, 4 weeks after randomization, and 8 weeks after discharge. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nerve Conduction Studies | This will be assessed using nerve conduction studies (NCS), which are a validated tool for assessing nerve function in individuals with carpal tunnel syndrome. NCS will be used to measure median nerve sensory and motor distal latency in addition to the amplitude of the median nerve. | Changes in nerve conduction studies at baseline, 4 weeks after randomization, and 8 weeks after discharge. | 
| Hand grip strength | This will be measured using a handheld dynamometer, which is a validated tool for assessing grip strength in individuals with carpal tunnel syndrome. Participants will be asked to squeeze the dynamometer as hard as possible, and the highest value of three trials for each hand will be recorded. | Changes in hand grip strength at baseline, 4 weeks after randomization, and 8 weeks after discharge. |