Thermal and Pulsed Ultrasound for Carpal Tunnel Syndrome

Ahram Canadian University

Status: Completed

Conditions: Carpal Tunnel Syndrome; Median Neuropathy, Carpal Tunnel

Treatments: Device: Placebo Ultrasound; Device: Thermal Ultrasound; Device: Combined Ultrasound; Device: Pulsed Ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT05838807

012/004245

Details and patient eligibility

About

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.

Enrollment: 92 patients

Sex: All

Ages: 30 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adults aged 30-60 years old

2. 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

1. Prior surgery for carpal tunnel syndrome
2. History of wrist or hand fracture in the past year
3. Pregnancy or planning to become pregnant during the study period
4. Active infection or skin condition in the treatment area
5. Known allergy to ultrasound gel or other components of the treatment
6. Use of corticosteroids or other medications that may affect nerve function within the past 3 months
7. Participation in another clinical trial within the past 30 days

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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92 participants in 4 patient groups, including a placebo group

Group A: Thermal Ultrasound Group

Experimental group

Treatment:

Device: Thermal Ultrasound

Group B: Pulsed Ultrasound Group:

Experimental group

Treatment:

Device: Pulsed Ultrasound

Group C: Combination Group

Experimental group

Treatment:

Device: Combined Ultrasound

Group D: Placebo Group

Placebo Comparator group

Treatment:

Device: Placebo Ultrasound