Effect of Different Doses of US in the Treatment of CTS
NCT ID: NCT05863546
Last Updated: 2025-03-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2023-09-10
2024-04-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Control group
(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.
Traditional treatment
The patients received traditional physical therapy treatment for carpal tunnel syndrome, in the form of hot packs, tendon and nerve glide exercises, and wrist splint for 4 weeks.
Therapeutic ultrasound
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
(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 1:4 plus traditional treatment.
Traditional treatment
The patients received traditional physical therapy treatment for carpal tunnel syndrome, in the form of hot packs, tendon and nerve glide exercises, and wrist splint for 4 weeks.
Therapeutic ultrasound
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
(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 1:4 plus traditional treatment.
Traditional treatment
The patients received traditional physical therapy treatment for carpal tunnel syndrome, in the form of hot packs, tendon and nerve glide exercises, and wrist splint for 4 weeks.
Therapeutic ultrasound
US treatment sessions were performed for 6 min per session, once a day, three days a week, for a total of 4 weeks.
High-dose group
(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 1:4 plus traditional treatment.
Traditional treatment
The patients received traditional physical therapy treatment for carpal tunnel syndrome, in the form of hot packs, tendon and nerve glide exercises, and wrist splint for 4 weeks.
Therapeutic ultrasound
US treatment sessions were performed for 6 min per session, once a day, three days a week, for a total of 4 weeks.
Interventions
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Traditional treatment
The patients received traditional physical therapy treatment for carpal tunnel syndrome, in the form of hot packs, tendon and nerve glide exercises, and wrist splint for 4 weeks.
Therapeutic ultrasound
US treatment sessions were performed for 6 min per session, once a day, three days a week, for a total of 4 weeks.
Eligibility Criteria
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Inclusion Criteria
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
2. Cervical radiculopathy, peripheral polyneuropathy, or other neurological conditions.
3. Patients suffering from severe CTS according to electrophysiological criteria
\-
25 Years
55 Years
ALL
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Omnia Gamal Mohamed
physical therapist
Principal Investigators
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Ragia Mohamed Kamel, PhD
Role: STUDY_CHAIR
Professor, Cairo university
Locations
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Ismailia Medical Complex
Ismailia, , Egypt
Countries
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Other Identifiers
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P.T.REC/012/003996
Identifier Type: -
Identifier Source: org_study_id
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