- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06229249
Effectiveness of Carpal Ligament Self-myofascial Stretching in Carpal Tunnel Syndrome
January 19, 2024 updated by: Masood Khan, King Saud University
Effectiveness of Carpal Ligament Self-myofascial Stretching Over Conventional Physical Therapy on Reducing Pain and Improving Function in Patients With Stage i and ii Carpal Tunnel Syndrome - a Comparative Study
Carpal tunnel syndrome (CTS), also known as median mononeuropathy, occurs when the median nerve is squeezed or compressed as it travels through the carpal tunnel at the wrist.
It is common in the age group of 40-60 years.
The main aim of the study was to compare the effectiveness of carpal ligament self-myofascial stretching over conventional physical therapy on reducing pain and improving function in patients with stage I and II CTS-thirty-six subjects with stage I and II (mild) CTS were recruited.
Thirty-six subjects who fulfilled the inclusion criteria were randomly assigned to the experimental group and control group, with 18 patients in each group.
The experimental group received carpal ligament self-myofascial stretching along with conventional physical therapy, while the control group received traditional physical therapy alone.
The duration of the treatment was six weeks.
The outcome measures used were the Boston Carpal Tunnel Questionnaire and the Visual Analogue Scale.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Riyadh, Saudi Arabia, 11433
- King Saud University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients diagnosed with CTS between age group 30 - 60 years.
- Patients with stage I and II (mild) CTS, confirmed by nerve conduction study (EMG diagnosed by a medical professional).
- Patients who are able to read and understand English.
Exclusion Criteria:
- Presence of polyneuropathy.
- Consistent use of adaptive equipment, such as wheel chair or cane.
- Patients presenting with shoulder pathologies.
- Patients with other neurological or musculoskeletal conditions including Cervical radiculopathy, History of wrist and hand fractures, Upper extremity joint dislocations, Brachial plexus injuries, Cubital tunnel syndrome, Rheumatoid arthritis, De quervain's tenosynovitis, Cut injuries of hand.
- Patients who have underwent recent carpal tunnel release (within 1 year).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental group
The participants in this group received carpal ligament self-myofascial stretching along with conventional physical therapy.
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Carpal ligament self-myofascial stretching is a technique that involves applying pressure and stretching to the carpal ligaments and surrounding myofascial tissues of the wrist and hand.
The objective is to release tension, improve flexibility, and alleviate discomfort or pain in the wrist and hand area.
|
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Active Comparator: Control group
The participants in this group received conventional physical therapy.
|
In this technique, ultrasound therapy, nerve gliding exercise, tendon gliding exercise, and wrist splinting were performed.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Boston Carpal Tunnel Questionnaire
Time Frame: 6 weeks
|
The Boston carpal tunnel syndrome is a disease-specific patient-filled questionnaire, which comprises of two scales, a symptom severity scale (SSS) and a functional status scale (FSS).
The symptom severity scale has 11 questions scored from 1 point (mildest) to 5 points (most severe) and the functional status scale has eight questions scored from 1 point (no difficulty with activity) to 5 points (cannot perform the activity at all).
The greater the score, the more severe the severity of the disease.
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6 weeks
|
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Visual Analogue Scale
Time Frame: 6 weeks.
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The visual analogue scale consists of a 10-cm line, with the left extremity representing (the absence of pain) and the right extremity indicating (great pain).
The greater the score, the more severe will be the pain.
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6 weeks.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Masood Khan, MPTh, King Saud University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 17, 2022
Primary Completion (Actual)
April 10, 2023
Study Completion (Actual)
May 15, 2023
Study Registration Dates
First Submitted
January 19, 2024
First Submitted That Met QC Criteria
January 19, 2024
First Posted (Estimated)
January 29, 2024
Study Record Updates
Last Update Posted (Estimated)
January 29, 2024
Last Update Submitted That Met QC Criteria
January 19, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AWH/EC/01/2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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