Thermal and Pulsed Ultrasound for Carpal Tunnel Syndrome

NCT05838807 | Completed

• 1 other identifier: 012/004245
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Nerve Conduction Studies

  Changes in nerve conduction studies at baseline, 4 weeks after randomization, and 8 weeks after discharge.

• Hand grip strength

  Changes in hand grip strength at baseline, 4 weeks after randomization, and 8 weeks after discharge.

Study Arms (4)

Group A: Thermal Ultrasound Group

EXPERIMENTAL

Device: Thermal Ultrasound

Group B: Pulsed Ultrasound Group:

EXPERIMENTAL

Device: Pulsed Ultrasound

Group C: Combination Group

EXPERIMENTAL

Device: Combined Ultrasound

Group D: Placebo Group

PLACEBO COMPARATOR

Device: Placebo Ultrasound

Interventions

Thermal Ultrasound 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 A: Thermal Ultrasound Group

Pulsed Ultrasound 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 B: Pulsed Ultrasound Group:

Combined Ultrasound 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 C: Combination Group

Placebo Ultrasound 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.

Group D: Placebo Group

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adults aged 30-60 years old
• 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

You may not qualify if:

• Prior surgery for carpal tunnel syndrome
• History of wrist or hand fracture in the past year
• Pregnancy or planning to become pregnant during the study period
• Active infection or skin condition in the treatment area
• Known allergy to ultrasound gel or other components of the treatment
• Use of corticosteroids or other medications that may affect nerve function within the past 3 months
• Participation in another clinical trial within the past 30 days

Sponsors & Collaborators

• Ahram Canadian University: lead

Study Sites (1)

Outpatient clinic of faculty of physical therapy, Ahram Canadian University

Al Ḩayy Ath Thāmin, Giza Governorate, 3221405, Egypt

Location

Related Publications (1)

• 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.

  PMID: 39773605 DERIVED

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Transurethral Resection of Prostate

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Prostatectomy; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Amal Fawzy, Ph.d

  Faculty of Physical Therapy, Ahram Canadian University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: In addition to the participants being blinded to the treatment they are receiving, the outcome assessors will also be blinded to the treatment assignment. This will ensure that the assessors are unbiased when measuring the outcome measures of pain intensity, functional status, and nerve conduction studies.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Physical Therapy and Director of Electromyography Lab

Model Details: The study will be a level II randomized controlled trial with a parallel group design. Participants will be randomized to receive one of four interventions: thermal ultrasound, pulsed ultrasound, a combination of both, or a placebo treatment. Participants will receive their assigned treatment for 10 minutes, three times per week, for 4 weeks.

Study Record Dates

• First Submitted: April 19, 2023
• First Posted: May 3, 2023
• Study Start: May 28, 2023
• Primary Completion: March 14, 2024
• Study Completion: March 14, 2024
• Last Updated: April 2, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF
• Time Frame: During the trial and 1 year after the trial end.
• Access Criteria: via email to mohamed.elmeligie@acu.edu.eg

Locations

EG (1)