Effect of Different Doses of US in the Treatment of CTS

Carpal Tunnel Syndrome Clinical Trial

Official title:

Effect of Different Doses of Therapeutic Ultrasound in the Treatment of Carpal Tunnel Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05863546
• Other study ID #: US in carpal tunnel syndrome
• Status: Recruiting
• Phase: N/A
• Start date: September 10, 2023
• Est. completion date: April 2024

Study information

• Verified date: September 2023
• Source: Cairo University
• Contact: omnia mohamed, master
• Phone: 01099683292
• Email: monygamal1988[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study will be to investigate the effective dose of therapeutic ultrasound in the treatment of carpal tunnel syndrome on pain level, functional ability, motor and sensory nerve conduction parameters and pinch strength.

Description:

Carpal tunnel syndrome (CTS) is among the most common peripheral neuropathies causing the median nerve compression as it crosses the carpal tunnel, with an estimated prevalence of about 4 - 5% of the general population. Patients suffering from this syndrome mainly complain about paresthesia (pain, numbness, and tingling) in the innervation area of the median nerve in the hand which could be accompanied by weakness and atrophy of thenar muscles.

Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy of the upper limb and a significant contributor to hand functional impairment and disability that could be treated through numerous approaches. Effective treatment options include conservative and surgical interventions.

Carpal Tunnel Syndrome (CTS) remains a puzzling and disabling condition present in 3.8% of the general population. CTS is the most well-known and frequent form of median nerve entrapment, and accounts for 90% of all entrapment neuropathies.

Physiotherapy modalities are used to help patients with CTS in many cases. They can both help to improve CTS symptoms as well as resolve the cause of the syndrome. Physiotherapy intervention may include special exercises, mobilizations, ergonomic interventions and advice for as well as electrotherapy modalities, aiming for the treatment and improvement of symptoms.

Ultrasound waves have anti-inflammatory properties, stimulating nerve regeneration and improving nerve conductivity.

The most common uses for US are to decrease soft tissue inflammation, increase tissue extensibility, enhance scar tissue remodeling, increase soft tissue healing, decrease pain, and decrease soft tissue swelling .

The issue of selecting the nature of the ultrasonic wave has not been finally resolved. A continuous wave is more often used to reduce pain and increase the elasticity of the tissue, while a pulsed wave mode is applied to reduce swelling and to eliminate inflammation. The rate of absorption, and thus the thermal effect, is based on the tissue type encountered, the frequency of the ultrasound beam, and the intensity (W/cm2) of the ultrasonic output.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Subject's age range will be 25-55 years .

2. Mild to moderate CTS, that is confirmed by neurologist or orthopedist based on results of physical examination and electrophysiological criteria; i. Mild CTS is characterized by sensory fibers involvement (sensory peak latency > 3.6 milliseconds) with no motor fiber involvement (motor distal latency < 4.1 milliseconds), provided that sensory nerve action potential (SNAP) is not absent.

ii. Moderate CTS is characterized by involvement of both sensory and motor fibers, provided that neither of these two waves is absent .

3. Pain intensity more than 5 in visual analogue scale (VAS).

Exclusion Criteria:

1. History of any trauma on the hands, neck, and shoulders within 3 months of the study onset

2. Cervical radiculopathy, peripheral polyneuropathy, or other neurological conditions.

3. Patients suffering from severe CTS according to electrophysiological criteria

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Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

Device:
• therapeutic ultrasound
US treatment sessions will be performed for 6 min per session , once a day, three days a week, for a total of 4 weeks.

Locations

Country	Name	City	State
Egypt	Ismailia Medical Complex	Ismailia

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	symptoms severity and functional status	symptoms severity and functional status will be measured by Boston carpal tunnel syndrome questionnaire,The patient will rate their ability to perform the activity on a scale that ranged from 1 (no difficulty with the activity) to 5 (cannot perform the activity at all).	four weeks following end of treatment
Primary	median nerve motor distal latency	Electrodiagnostic tests will be used to measure median nerve motor distal latency in milliseconds.	four weeks following end of treatment
Primary	median nerve motor amplitude	Electrodiagnostic tests will be used to measure motor amplitude in millivolt.	four weeks following end of treatment
Primary	median nerve sensory distal latency	Electrodiagnostic tests will be used to measure median nerve sensory distal latency in milliseconds.	four weeks following end of treatment
Primary	median nerve sensory amplitude	Electrodiagnostic tests will be used to measure sensory amplitude in millivolt	four weeks following end of treatment
Primary	pain intensity	pain intensity will be measured by visual analogue scale that is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable,minimum score is best	four weeks following end of treatment
Primary	pinch strength	Pinch dynamometer will be used to measure pinch strength	four weeks following end of treatment