Low Intensity Ultrasound in Patients With Carpal Tunnel Syndrome

NCT05637684 | Completed

• 1 other identifier: LIPUS
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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

Conditions

Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (3)

• median nerve sensory distal latency

  Measurements of sensory distal latency of median nerve (Antidromic technique ) 1. Recording electrode or Ring electrode (R1, R2): at the index finger the negative electrode is between 2-3 cm to positive electrode (Distance between stimulating and recording sites 5 cm). 2. Stimulating site (S): at the wrist (Middle of the wrist between the tendons to the flexor carpi radialis and palmaris longus) Ground (Earth) electrode (G): between stimulating and recording electrodes will be placed at the palmar surface of the wrist crease.

  4 WEEKS

• median nerve motor distal latency

  Measurements of motor distal latency of median nerve (Using Orthodromic technique) 1. Recording (-) active electrode (R1): abductor pollicis brevis (APB). Reference(+) electrode (R2): placed over the first metacarpal-phalangeal joint 2. Stimulating electrode (S): 2 stimulating sites at wrist and antecubital fossa (Cathode toward recording electrode). 3. Ground (Earth) electrode (G): around the wrist crease between stimulating and recording electrodes

  4 WEEKS

• pinch grip strength

  grip strength will be measured using a calibrated baseline hydraulic dynamometer, while the subject will be seated with the arm adducted, elbow flexed at 90 degree, forearm in neutral position firstly, therapist will ask patient to hold the dynamometer between the tip of the thumb and tip of the index finger it called (tip to tip pinch), as hard as possible in the hand to be tested, the patients strongly encouraged to give a maximum effort. One practice trial, Repeat the test 3 times and calculate an average with one min rest in between

  4 weeks

Study Arms (2)

low intensity pulsed ultrasound group

EXPERIMENTAL

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

Device: low intensity pulsed ultrasound

control group

SHAM COMPARATOR

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

Device: low intensity pulsed ultrasound

Interventions

low intensity pulsed ultrasound DEVICE

mechanical sound waves

control group; low intensity pulsed ultrasound group

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• male and 26 female patients have unilateral with mild to moderate CTS in dominant hand diagnosed and referred by physician.
• Age will be ranged from 30-50 years
• All patients have body mass index between 18.5 and 24.9 kg/m2
• 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.
• Positive clinical manifestation (pain, paresthesia in the distribution of the median nerve for 6 months, positive Tinel's and Phalen's sign)

You may not qualify if:

• Patients with diabetes mellitus ( type I or type II),
• Patients with hypothyroidism
• Patients with rheumatoid disease
• Patients with renal disease
• Patients with polyneuropathy
• patients with cervical radiculopathy
• Patients with wrist arthritis , wrist fracture and acute trauma
• Patients with Carpal tunnel release surgery
• Patients with outlet syndrome
• thenar muscle atrophy -

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy Cairo University

Giza, Dokki, 11432, Egypt

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

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

Study Officials

• FAHD A HASSAN

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Model Details: randomized controlled trial

Study Record Dates

• First Submitted: November 14, 2022
• First Posted: December 5, 2022
• Study Start: November 1, 2022
• Primary Completion: April 30, 2024
• Study Completion: August 20, 2024
• Last Updated: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)