- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05529537
Manual Lymphatic Drainage for Rheumatoid Arthritis
December 16, 2022 updated by: Emine Cihan, Selcuk University
The Effect of Manual Lymphatic Drainage on Upper Extremity Functionality in Rheumatoid Arthritis Patients
Rheumatoid arthritis (RA) is a chronic, progressive, autoimmune disease characterized by inflammation of the synovial joints and tendon sheaths.
As a result of synovitis, progressive damage occurs in cartilage, bone and joints.
This damage leads to severe functional limitations and deterioration in quality of life.
Synovial tissues are the main site of involvement.
Manual lymph drainage reduces the levels of inflammatory mediators associated with edema and pain in the acute phase.
On the basis of this concept; Stimulating the lymph system and increasing circulation, removing biochemical residues, regulating sympathetic and parasympathetic system responses, and thus reducing edema and pain.
The increase in cardiac parasympathetic activity measured after MLD also contributes to relaxation.
In addition to the transport of lymphatic fluid, manual lymph drainage stimulates free nerve endings in the skin with the touches it contains.
Gentle stimulation to the skin increases tactile input and closes the pain pathways.
In addition, the superficial relaxation and warming provided by soft stimulation creates an effect on the autonomic nervous system and activates the parasympathetic system.
The aim of this study is to evaluate the effect of manual lymphatic drainage on upper extremity functionality in individuals with rheumatoid arthritis.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
39
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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Kütahya, Turkey, 43100
- Kutahya Health Science University Hospital
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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
21 years to 61 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Diagnosed with RA according to ACR criteria
- Being between the ages of 18-65
- Volunteering to participate in the study
Exclusion Criteria:
- Presence of neuromuscular disease
- Having difficulty walking
- Cognitive impairment
- Having systemic disease such as diabetes mellitus and osteoarthritis
- History of upper extremity sIf you have Hand Deformity
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
|
upper extremity normal joint range of motion exercise, strengthening exercise, tendon gliding exercises
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Experimental: MLD
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upper extremity normal joint range of motion exercise, strengthening exercise, tendon gliding exercises
In addition to conventional treatment for 4 weeks, manual lymph drainage will be applied to the patients.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rheumatoid Arthritis Quality of Life Scale (QOL-RA)
Time Frame: 10 minutes
|
In the scale consisting of 30 questions; questions are scored as "yes-1" and "no-0".
The scores obtained range from 0-30, and high scores indicate poor quality of life.
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10 minutes
|
|
pressure pain threshold
Time Frame: 5 minutes
|
It is used for the assessment of sensitivity to pain and the determination of pressure perception.
will be evaluated with a digital algometer device with a surface area of 1 cm2 and a sensitivity of 0.25 kg/cm2 (Jtech Medical Industries, ZEVEX Company, USA).
|
5 minutes
|
|
hand grip strength
Time Frame: 5 minutes
|
The Jamar hand dynamometer, which is recommended by the American Association of Hand Therapists (AETD) and has high validity and reliability in many studies and is therefore accepted as the gold standard, will be used.
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5 minutes
|
|
finger grip strength
Time Frame: 5 minutes
|
Finger pinchmeter (Baseline) will be used to measure finger grip strength.
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5 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)
August 17, 2022
Primary Completion (Actual)
September 30, 2022
Study Completion (Actual)
October 1, 2022
Study Registration Dates
First Submitted
September 1, 2022
First Submitted That Met QC Criteria
September 2, 2022
First Posted (Actual)
September 7, 2022
Study Record Updates
Last Update Posted (Actual)
December 19, 2022
Last Update Submitted That Met QC Criteria
December 16, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022/08-01
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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