Effect of Different Doses of US in the Treatment of CTS

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Carpal Tunnel Syndrome

Intervention / Treatment
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* Device: therapeutic ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject's age range will be 25-55 years . 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 . Pain intensity more than 5 in visual analogue scale (VAS). Exclusion Criteria: History of any trauma on the hands, neck, and shoulders within 3 months of the study onset Cervical radiculopathy, peripheral polyneuropathy, or other neurological conditions. Patients suffering from severe CTS according to electrophysiological criteria -

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: control group<br>(control group) It will consist of 15 subjects who will receive a program of 'sham' US application, so that the US device will be working but not delivering any output plus traditional PT treatment for carpal tunnel syndrome which includes hot packs, tendon glide and nerve glide exercises, US treatment sessions will be performed for 6 min per session , once a day, three days a week, for a total of 4 weeks. | Device: therapeutic ultrasound<br>* US treatment sessions will be performed for 6 min per session , once a day, three days a week, for a total of 4 weeks.<br>|
| Experimental: low-dose group<br>(low-dose group) It will consist of 15 subjects who will receive a program of US treatments that will be administered to the carpal tunnel area with pulsed mode at a frequency of 1 MHz with an intensity of 0.25 W/cm2 and a duty cycle of 1:5 plus traditional treatment. | Device: therapeutic ultrasound<br>* US treatment sessions will be performed for 6 min per session , once a day, three days a week, for a total of 4 weeks.<br>|
| Experimental: Mid-dose group<br>(Mid-dose group) It will consist of 15 subjects who will receive a program of US treatments that will be administered to the carpal tunnel area with pulsed mode at a frequency of 1 MHz with an intensity of 0.5 W/cm2 and a duty cycle of 1:5 plus traditional treatment. | Device: therapeutic ultrasound<br>* US treatment sessions will be performed for 6 min per session , once a day, three days a week, for a total of 4 weeks.<br>|
| Experimental: high-dose group<br>(high-dose group) It will consist of 15 subjects who will receive a program of the same US equipment that will be set at pulsed mode at a frequency of 1 MHz, intensity of 1.0W/ cm2 and a duty cycle of 1:5 plus traditional treatment. | Device: therapeutic ultrasound<br>* US treatment sessions will be performed for 6 min per session , once a day, three days a week, for a total of 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| median nerve motor amplitude | Electrodiagnostic tests will be used to measure motor amplitude in millivolt. | four weeks following end of treatment | 
| 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 | 
| median nerve sensory amplitude | Electrodiagnostic tests will be used to measure sensory amplitude in millivolt | four weeks following end of treatment | 
| 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 | 
| pinch strength | Pinch dynamometer will be used to measure pinch strength | four weeks following end of treatment |