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

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.

Study Overview

• Status: Completed
• Conditions: Carpal Tunnel Syndrome; Median Neuropathy, Carpal Tunnel
• Intervention / Treatment: Device: Thermal Ultrasound; Device: Pulsed Ultrasound; Device: Combined Ultrasound; Device: Placebo Ultrasound

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza
    • Al Ḩayy Ath Thāmin, Giza, Egypt, 3221405
      • Outpatient clinic of faculty of physical therapy, Ahram Canadian University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A: Thermal Ultrasound Group	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.
Experimental: Group B: Pulsed Ultrasound Group:	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.
Experimental: Group C: Combination Group	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.
Placebo Comparator: Group D: Placebo Group	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Collaborators and Investigators

• Sponsor: Ahram Canadian University
• Investigators: Study Chair: Amal Fawzy, Ph.d, Faculty of Physical Therapy, Ahram Canadian University

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2023
• Primary Completion (Actual): March 14, 2024
• Study Completion (Actual): March 14, 2024

Study Registration Dates

• First Submitted: April 19, 2023
• First Submitted That Met QC Criteria: May 1, 2023
• First Posted (Actual): May 3, 2023

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: March 30, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Wounds and Injuries; Disease; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Syndrome; Carpal Tunnel Syndrome; Median Neuropathy
• Other Study ID Numbers: 012/004245

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The individual participant data (IPD) collected during this study will be available upon reasonable request. Requests for access to the data should be submitted via email to mohamed.elmeligie@acu.edu.eg. All requests will be reviewed by the study investigators to ensure that they are reasonable and consistent with the ethical principles of the study. Access to the data will be granted in compliance with applicable laws and regulations, and with appropriate safeguards to protect the privacy and confidentiality of study participants.
• IPD Sharing Time Frame: During the trial and 1 year after the trial end.
• IPD Sharing Access Criteria: via email to mohamed.elmeligie@acu.edu.eg
• IPD Sharing Supporting Information Type: SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No