Thermal and Pulsed Ultrasound for Carpal Tunnel Syndrome

Carpal Tunnel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05838807
• Other study ID #: 012/004245
• Status: Completed
• Phase: N/A
• Start date: May 28, 2023
• Est. completion date: March 14, 2024

Study information

• Verified date: March 2024
• Source: Ahram Canadian University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: March 14, 2024
• Est. primary completion date: March 14, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Median Neuropathy
• Median Neuropathy, Carpal Tunnel
• Syndrome

Intervention

Device:
• Thermal Ultrasound
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.
• Pulsed Ultrasound
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.
• Combined Ultrasound
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.
• Placebo Ultrasound
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.

Locations

Country	Name	City	State
Egypt	Outpatient clinic of faculty of physical therapy, Ahram Canadian University	Al ?ayy Ath Thamin	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Ahram Canadian University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.
Secondary	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.