Thermal and Pulsed Ultrasound for Carpal Tunnel Syndrome

NCT ID: NCT05838807

Last Updated: 2024-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-28
• Study Completion Date: 2024-03-14

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.

Conditions

Carpal Tunnel Syndrome; Median Neuropathy, Carpal Tunnel

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group A: Thermal Ultrasound Group

Group Type: EXPERIMENTAL

Thermal Ultrasound

Intervention Type: DEVICE

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.

Group B: Pulsed Ultrasound Group:

Group Type: EXPERIMENTAL

Pulsed Ultrasound

Intervention Type: DEVICE

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.

Group C: Combination Group

Group Type: EXPERIMENTAL

Combined Ultrasound

Intervention Type: DEVICE

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.

Group D: Placebo Group

Group Type: PLACEBO_COMPARATOR

Placebo Ultrasound

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ahram Canadian University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Magdy ElMeligie

Lecturer of Physical Therapy and Director of Electromyography Lab

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amal Fawzy, Ph.d

Role: STUDY_CHAIR

Faculty of Physical Therapy, Ahram Canadian University

Locations

Outpatient clinic of faculty of physical therapy, Ahram Canadian University

Al Ḩayy Ath Thāmin, Giza Governorate, Egypt

Countries

Egypt

References

ElMeligie MM, Ismail MM, Yehia AM, Sakr HR, Amin DI. Effects of Thermal and Pulsed Ultrasound on Pain and Function in Patients With Carpal Tunnel Syndrome: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2025 Jun 1;104(6):e83-e91. doi: 10.1097/PHM.0000000000002651. Epub 2024 Nov 11.

Reference Type: DERIVED

PMID: 39773605 (View on PubMed)

Other Identifiers

012/004245

Identifier Type: -

Identifier Source: org_study_id