Low Intensity Ultrasound in Patients With Carpal Tunnel Syndrome

NCT ID: NCT05637684

Last Updated: 2025-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2024-08-20

Brief Summary

To investigate the influence of low intensity pulsed ultrasound on Pain level, pinch grip strength, sensory distal latency of the median nerve, motor distal latency of the median nerve and hand function in patients with chronic carpal tunnel syndrome

Detailed Description

Carpal tunnel syndrome (CTS) is an entrapment neuropathy caused by compression of the median nerve as it travels through the wrist's carpal tunnel. It is the most common nerve entrapment neuropathy, accounting for 90% of all neuropathies. Early symptoms of carpal tunnel syndrome include pain, numbness, and paresthesia. These symptoms typically present, with some variability, in the thumb, index finger, middle finger, and the radial half (thumb side) of the ring finger. Pain also can radiate up the affected arm. With further progression, hand weakness, decreased fine motor coordination, clumsiness, and thenar atrophy can occur.

Low-intensity ultrasound (LIU) and low-intensity pulsed ultrasound (LIPUS) are known to have positive effects on dentin genesis, cell proliferation, protein synthesis, collagen synthesis, membrane permeability, and integrin expression and to increase cytosolic calcium levels.

Conditions

Carpal Tunnel Syndrome

Study Design

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

Study Groups

low intensity pulsed ultrasound group

low intensity pulsed ultrasound application The following parameters will be used: intensity of 0.3 W/cm2 at a 1megahertz frequency for 20 minutes and pulsed (20%) ultrasound waves and conventional physical therapy program will be used for this group in a form of wrist hand Splint ,Medical Massage (effleurage),Passive stretching for wrist flexor, Carpal mobilization and Strengthening exercise

Group Type: EXPERIMENTAL

low intensity pulsed ultrasound

Intervention Type: DEVICE

mechanical sound waves

control group

conventional physical therapy program will be used for this group in a form of wrist hand Splint ,Medical Massage (effleurage),Passive stretching for wrist flexor, Carpal mobilization and Strengthening exercise

Group Type: SHAM_COMPARATOR

low intensity pulsed ultrasound

Intervention Type: DEVICE

mechanical sound waves

Interventions

low intensity pulsed ultrasound

mechanical sound waves

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. 26 male and 26 female patients have unilateral with mild to moderate CTS in dominant hand diagnosed and referred by physician.

2. Age will be ranged from 30-50 years

3. All patients have body mass index between 18.5 and 24.9 kg/m2

4. Median nerve sensory distal latency > 3.5 millisecond but not more than 4.5 millisecond, motor distal latency longer than 4.2 millisecond but not exceed 6.5 millisecond.

5. Positive clinical manifestation (pain, paresthesia in the distribution of the median nerve for 6 months, positive Tinel's and Phalen's sign)

Exclusion Criteria

1. Patients with diabetes mellitus ( type I or type II),

2. Patients with hypothyroidism

3. Patients with rheumatoid disease

4. Patients with renal disease

5. Patients with polyneuropathy

6. patients with cervical radiculopathy

7. Patients with wrist arthritis , wrist fracture and acute trauma

8. Patients with Carpal tunnel release surgery

9. Patients with outlet syndrome

10. thenar muscle atrophy -

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

fahd abdelazim hassan abdelgalil

principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

FAHD A HASSAN

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Faculty of Physical Therapy Cairo University

Giza, Dokki, Egypt

Countries

Egypt

Other Identifiers

LIPUS

Identifier Type: -

Identifier Source: org_study_id