- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05394870
Clinical and Electrophysiological Evaluation of the Effectiveness for Manual Lymphatic Drainage
July 5, 2022 updated by: Emine Cihan, Selcuk University
Clinical and Electrophysiological Evaluation of the Effectiveness of Manual Lymphatic Drainage in Patients With Mild-to-moderate Carpal Tunnel Syndrome
When the other usage areas of the manual lymphatic drainage technique in the literature, except for the treatment of lymphedema, were examined recently, it was seen that it was also applied in orthopedic and neurological cases in a limited number of studies.
The aim of our study is to investigate the effectiveness of manual lymphatic drainage on clinical and electrophysiological findings in carpal tunnel syndrome
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
34
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
-
-
Centrum
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Kütahya, Centrum, Turkey, 43040
- Kutahya Health Science University
-
-
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
16 years to 51 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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 circulation disorder that would contraindicate manual lymphatic drainage
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: control group
|
The splint routinely given to patients diagnosed with mild to moderate carpal tunnel syndrome will be given to both groups in these patients
|
|
Experimental: study group
|
Patients will begin treatment with manual lymphatic drainage in the affected extremity.
In this context, while the patients are in the supine hook position, lymph drainage will be applied first to the neck and then to the abdomen.
After the stimulation of the central lymph nodes, the lymph circulation will be increased by stimulating the axillary lymph nodes of the relevant region.
First, the proximal part will be drained and it will be advanced towards the distal.
Drainage will be repeated depending on the edema at the distal forearm-wrist level.
The splint routinely given to patients diagnosed with mild to moderate carpal tunnel syndrome will be given to both groups in these patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pressure pain threshold
Time Frame: 15 minutes
|
Each evaluation will be repeated 3 times with 10 seconds between measurements, and the data will be recorded by taking the average of the last two measurements (15).
The patients will be evaluated by measuring the transverse carpal ligament, radioulnar joint and extensor digitorum muscle with an algometer before and at the end of the treatment.
measurements will be recorded in kg/cm2
|
15 minutes
|
|
Boston Carpal Tunnel Questionnaire (BCTQ)
Time Frame: 10 minutes
|
BCTQ, a self-report measure of CTS, evaluates two domains: 1.
The symptom severity scale (BCTQSS) has 11 items that assess 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 high score.
|
10 minutes
|
|
Electrodiagnostic evaluation
Time Frame: 15 minutes
|
Median motor nerve latency, median motor nerve conduction velocity, compound muscle action potential amplitude will be measured at both levels.
Median sensory nerve conduction studies will be performed by antidromic recording with a superficial electrode from the 3rd finger and a stimulus will be given from the wrist 14 cm proximal.
Median sensory nerve latency, median sensory nerve conduction velocity and sensory nerve action potential will be calculated for both applications.
nerve potentials will be calculated in m/sec
|
15 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)
April 1, 2022
Primary Completion (Actual)
June 1, 2022
Study Completion (Actual)
June 10, 2022
Study Registration Dates
First Submitted
May 19, 2022
First Submitted That Met QC Criteria
May 24, 2022
First Posted (Actual)
May 27, 2022
Study Record Updates
Last Update Posted (Actual)
July 6, 2022
Last Update Submitted That Met QC Criteria
July 5, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-03.02
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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