NCT05838807

Thermal and Pulsed Ultrasound for Carpal Tunnel Syndrome

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Ahram Canadian University · Academic / Other
• Sex: All
• Age: 30 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Carpal Tunnel Syndrome
• Median Neuropathy, Carpal Tunnel

Interventions

Type	Name	Description
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.
DEVICE	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.
DEVICE	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.
DEVICE	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.

Timeline

• Start date: 2023-05-28
• Primary completion: 2024-03-14
• Completion: 2024-03-14
• First posted: 2023-05-03
• Last updated: 2024-04-02

Locations

1 site across 1 country: Egypt