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NCT Number: NCT05637684

Low Intensity Ultrasound in Patients With Carpal Tunnel Syndrome

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

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Key information

Conditions

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

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Physical Therapy Cairo University

Giza, Dokki, 11432, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 26 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)

Exclusion criteria

  • 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 -

Treatment and study plan

Low intensity pulsed ultrasound

Device

mechanical sound waves

Primary outcomes

  1. median nerve sensory distal latency

    Time frame: 4 WEEKS

    Measurements of sensory distal latency of median nerve (Antidromic technique )

    • 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).
    • 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.

  2. median nerve motor distal latency

    Time frame: 4 WEEKS

    Measurements of motor distal latency of median nerve (Using Orthodromic technique)

    • Recording (-) active electrode (R1): abductor pollicis brevis (APB). Reference(+) electrode (R2): placed over the first metacarpal-phalangeal joint
    • Stimulating electrode (S): 2 stimulating sites at wrist and antecubital fossa (Cathode toward recording electrode).
    • Ground (Earth) electrode (G): around the wrist crease between stimulating and recording electrodes

  3. pinch grip strength

    Time frame: 4 weeks

    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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Influence of Low Intensity Pulsed Ultrasound on Enhancing Biostimulation of Median Nerve in Patients With Chronic Carpal Tunnel Syndrome

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 5, 2022
Registry last updated
Feb 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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