Effect of Different Doses of US in the Treatment of CTS

Not Applicable

Completed

• Conditions: Carpal Tunnel Syndrome
• Interventions: Other: Traditional treatment; Device: Therapeutic ultrasound

• Registration Number: NCT05863546
• Lead Sponsor: Cairo University

Brief Summary

The purpose of this study was 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

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.

Study Timeline

• Study First Submitted: 2023-04-28
• Study First Submitted QC: 2023-05-15
• Study First Posted: 2023-05-18
• Study Start: 2023-09-10
• Primary Completion: 2024-03-01
• Study Completion: 2024-04-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-12
• Last Update Posted: 2025-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Subject's age range was 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mid-dose group	Therapeutic ultrasound	(Mid-dose group) It consisted of 15 subjects who received a program of US treatments that was 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.
Low-dose group	Therapeutic ultrasound	(low-dose group) It consisted of 15 subjects who received a program of US treatments that was 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.
Control group	Traditional treatment	(control group) It consisted of 15 subjects who received a program of 'sham' US application, so that the US device was working but not delivering any output plus traditional PT treatment for carpal tunnel syndrome which included hot packs, tendon glide and nerve glide exercises, US treatment sessions were performed for 6 min per session, once a day, three days a week, for a total of 4 weeks.
Low-dose group	Traditional treatment	(low-dose group) It consisted of 15 subjects who received a program of US treatments that was 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.
High-dose group	Therapeutic ultrasound	(high-dose group) It consisted of 15 subjects who received a program of the same US equipment that was 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.
Control group	Therapeutic ultrasound	(control group) It consisted of 15 subjects who received a program of 'sham' US application, so that the US device was working but not delivering any output plus traditional PT treatment for carpal tunnel syndrome which included hot packs, tendon glide and nerve glide exercises, US treatment sessions were performed for 6 min per session, once a day, three days a week, for a total of 4 weeks.
Mid-dose group	Traditional treatment	(Mid-dose group) It consisted of 15 subjects who received a program of US treatments that was 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.
High-dose group	Traditional treatment	(high-dose group) It consisted of 15 subjects who received a program of the same US equipment that was 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.

Primary Outcome Measures

Name	Time	Method
symptoms severity and functional status	Four weeks	Symptoms severity and functional status were measured by Boston carpal tunnel syndrome questionnaire. The patients rated 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).
median nerve motor distal latency	Four weeks	Electrodiagnostic tests were used to measure median nerve motor distal latency in milliseconds.
median nerve motor amplitude	Four weeks	Electrodiagnostic tests were used to measure motor amplitude in millivolt.
median nerve sensory distal latency	Four weeks	Electrodiagnostic tests were used to measure median nerve sensory distal latency in milliseconds.
median nerve sensory amplitude	Four weeks	Electrodiagnostic tests were used to measure sensory amplitude in millivolt
Pain intensity	Four weeks	Pain intensity was measured by visual analogue scale. Scores are based on self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale-"no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm).
Pinch strength	Four weeks	Pinch dynamometer was used to measure pinch strength

Trial Locations

Locations (1)

Ismailia Medical Complex; 🇪🇬 Ismailia, Egypt