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Effect of Different Doses of US in the Treatment of CTS

Primary Purpose

Carpal Tunnel Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
therapeutic ultrasound
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome

Eligibility Criteria

25 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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 -

Sites / Locations

  • Ismailia Medical ComplexRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

control group

low-dose group

Mid-dose group

high-dose group

Arm Description

(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.

(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.

(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.

(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.

Outcomes

Primary Outcome Measures

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).
median nerve motor distal latency
Electrodiagnostic tests will be used to measure median nerve motor distal latency in milliseconds.
median nerve motor amplitude
Electrodiagnostic tests will be used to measure motor amplitude in millivolt.
median nerve sensory distal latency
Electrodiagnostic tests will be used to measure median nerve sensory distal latency in milliseconds.
median nerve sensory amplitude
Electrodiagnostic tests will be used to measure sensory amplitude in millivolt
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
pinch strength
Pinch dynamometer will be used to measure pinch strength

Secondary Outcome Measures

Full Information

First Posted
April 28, 2023
Last Updated
September 11, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05863546
Brief Title
Effect of Different Doses of US in the Treatment of CTS
Official Title
Effect of Different Doses of Therapeutic Ultrasound in the Treatment of Carpal Tunnel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 10, 2023 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Experimental
Arm Description
(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.
Arm Title
low-dose group
Arm Type
Experimental
Arm Description
(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.
Arm Title
Mid-dose group
Arm Type
Experimental
Arm Description
(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.
Arm Title
high-dose group
Arm Type
Experimental
Arm Description
(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.
Intervention Type
Device
Intervention Name(s)
therapeutic ultrasound
Intervention Description
US treatment sessions will be performed for 6 min per session , once a day, three days a week, for a total of 4 weeks.
Primary Outcome Measure Information:
Title
symptoms severity and functional status
Description
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).
Time Frame
four weeks following end of treatment
Title
median nerve motor distal latency
Description
Electrodiagnostic tests will be used to measure median nerve motor distal latency in milliseconds.
Time Frame
four weeks following end of treatment
Title
median nerve motor amplitude
Description
Electrodiagnostic tests will be used to measure motor amplitude in millivolt.
Time Frame
four weeks following end of treatment
Title
median nerve sensory distal latency
Description
Electrodiagnostic tests will be used to measure median nerve sensory distal latency in milliseconds.
Time Frame
four weeks following end of treatment
Title
median nerve sensory amplitude
Description
Electrodiagnostic tests will be used to measure sensory amplitude in millivolt
Time Frame
four weeks following end of treatment
Title
pain intensity
Description
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
Time Frame
four weeks following end of treatment
Title
pinch strength
Description
Pinch dynamometer will be used to measure pinch strength
Time Frame
four weeks following end of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
omnia mohamed, master
Phone
01099683292
Email
monygamal1988@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
omnia mohamed, master
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ismailia Medical Complex
City
Ismailia
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed Ahmed, Doctor
Phone
0643213901
Email
mody2002mody@gmail.com
First Name & Middle Initial & Last Name & Degree
Ahmed M Ali, Doctor
Phone
0643225117
Email
marwazaki@yahoo.com

12. IPD Sharing Statement

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Effect of Different Doses of US in the Treatment of CTS

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