Thermal and Pulsed Ultrasound for Carpal Tunnel Syndrome

Not Applicable

Completed

• Conditions: Median Neuropathy, Carpal Tunnel; Carpal Tunnel Syndrome
• Interventions: Device: Pulsed Ultrasound; Device: Thermal Ultrasound; Device: Combined Ultrasound; Device: Placebo Ultrasound

• Registration Number: NCT05838807
• Lead Sponsor: Ahram Canadian University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-19
• Study First Submitted QC: 2023-05-01
• Study First Posted: 2023-05-03
• Study Start: 2023-05-28
• Status Verified: 2024-03
• Primary Completion: 2024-03-14
• Study Completion: 2024-03-14
• Last Update Submitted: 2024-03-30
• Last Update Posted: 2024-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B: Pulsed Ultrasound Group:	Pulsed Ultrasound	-
Group A: Thermal Ultrasound Group	Thermal Ultrasound	-
Group C: Combination Group	Combined Ultrasound	-
Group D: Placebo Group	Placebo Ultrasound	-

Primary Outcome Measures

Name	Time	Method
Functional Status	Changes in functional status at baseline, 4 weeks after randomization, and 8 weeks after discharge.	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).
Pain Intensity	Changes in pain intensity at baseline, 4 weeks after randomization, and 8 weeks after discharge.	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.

Secondary Outcome Measures

Name	Time	Method
Hand grip strength	Changes in hand grip strength at baseline, 4 weeks after randomization, and 8 weeks after discharge.	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.
Nerve Conduction Studies	Changes in nerve conduction studies at baseline, 4 weeks after randomization, and 8 weeks after discharge.	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.

Trial Locations

Locations (1)

Outpatient clinic of faculty of physical therapy, Ahram Canadian University; 🇪🇬 Al Ḩayy Ath Thāmin, Giza, Egypt