- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05415618
Ultrasonographic Evaluation of the Effectiveness of Different Techniques
March 12, 2024 updated by: Emine Cihan, Selcuk University
Clinical and Ultrasonographic Evaluation of Manual Lymphatic Drainage and Nerve Mobilization Techniques in Patients Diagnosed With Mild-Moderate Carpal Tunnel Syndrome
Carpal tunnel syndrome (CTS) occurs as a result of compression of the median nerve under the transverse ligament along the carpal tunnel.
The main cause of median nerve compression and carpal tunnel syndrome is increased volume in the carpal tunnel.
The pressure that edema puts on the nerve must be controlled in the early period.
Edema that persists beyond the inflammatory process can contribute to the fibrotic stage, delay healing, and even cause complications such as pain and stiffness.
Manual lymphatic drainage (MLD) is a specialized technique that involves gentle massage techniques and follows lymphatic pathways from proximal to distal and then from distal to proximal.
On the basis of this concept; Increasing circulation by stimulating the lymph system, removing biochemical residues, reducing edema and pain, and regulating sympathetic and parasympathetic system responses.
It is known that MLD rapidly regulates lymphatic circulation by creating a change in interstitial fluid pressure, thus preventing even arthrofibrotic tissue that may form after a traumatic situation, reducing edema that predisposes to pain, and increasing mobility.
Nerve gliding exercises are another method used in treatment.
By providing a sliding movement of the tendons and median nerve in the distal-proximal direction, mobilization of the surrounding soft tissues is achieved and dynamic ischemia is terminated.
The aim of this study is to determine the effectiveness of manual lymphatic drainage and nerve mobilization on clinical and ultrasonographic findings in carpal tunnel syndrome.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
30
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
-
-
-
Kütahya, Turkey, 43100
- Kutahya Health Science University Hospital
-
-
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
20 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Diagnosis of mild to moderate carpal tunnel syndrome on electrodiagnostic examination
- Being between 20-55 years old
- Volunteering to participate in the treatment to be given
Exclusion Criteria:
- Have a systemic inflammatory disease
- Having any disease that may cause polyneuropathy, such as diabetes mellitus
- Cognitive impairment
- Receiving psychotherapy
- Having a pacemaker
- illiterate
- Having a disease affecting the central nervous system
- Having a hearing problem
- Any skin disease that would contraindicate manual lymphatic drainage
- Arterial or venous circulatory disorders that would contraindicate manual lymphatic drainage
- NSAID drug use
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Kontrol group
|
In splint treatment, a volar-supported splint that keeps the wrist in a neutral position will be preferred and it will be recommended to both groups to be used only at night for 4 weeks.
|
Experimental: MLD group
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Manual lymphatic drainage will be applied 5 days a week for about 15 minutes every day for 4 weeks.
|
Experimental: Nerve gliding group
|
Median nerve gliding exercises as a home exercise program will be performed by the patient 5 days a week for 4 weeks.
It will be performed in 6 different consecutive positions of the hand and wrist.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ultrasonographic Evaluation
Time Frame: 20 minutes
|
Median nerve diameter measurements and depths of the participants will be made by USG with a multifrequency (7-15 MHz) linear probe.
With USG, the median CBF and its depth will be measured distally from the level of the scaphoid bone (wrist; carpal tunnel level) and the midpoint of the forearm.
|
20 minutes
|
Evaluation of symptom severity and functional status
Time Frame: 10 minutes
|
It will be assessed with the Boston Carpal Tunnel Questionnaire (BCTQ).
1.
The symptom severity scale (BCTQSS) has 11 items that evaluate pain, paresthesia, and weakness.
2. The functional status scale (BCTQ-FS) evaluates the ability to perform manual activities with 8 items.
Each item evaluates the increasing severity of symptoms or difficulty with a higher score.
|
10 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
March 12, 2024
Primary Completion (Estimated)
April 12, 2024
Study Completion (Estimated)
April 30, 2024
Study Registration Dates
First Submitted
June 8, 2022
First Submitted That Met QC Criteria
June 8, 2022
First Posted (Actual)
June 13, 2022
Study Record Updates
Last Update Posted (Actual)
March 15, 2024
Last Update Submitted That Met QC Criteria
March 12, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-14/01
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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