Manual Lymphatic Drainage for Rheumatoid Arthritis
Primary Purpose
Effect of Manual Lymphatic Drainage on Upper Extremity Functionality in Rheumatoid Arthritis
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
manual lymphatic drainage
excersize
Sponsored by
About this trial
This is an interventional treatment trial for Effect of Manual Lymphatic Drainage on Upper Extremity Functionality in Rheumatoid Arthritis
Eligibility Criteria
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
Sites / Locations
- Kutahya Health Science University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
control
MLD
Arm Description
Outcomes
Primary Outcome Measures
Rheumatoid Arthritis Quality of Life Scale (QOL-RA)
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.
pressure pain threshold
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).
hand grip strength
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.
finger grip strength
Finger pinchmeter (Baseline) will be used to measure finger grip strength.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05529537
Brief Title
Manual Lymphatic Drainage for Rheumatoid Arthritis
Official Title
The Effect of Manual Lymphatic Drainage on Upper Extremity Functionality in Rheumatoid Arthritis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
August 17, 2022 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
October 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Selcuk 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Effect of Manual Lymphatic Drainage on Upper Extremity Functionality in Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control
Arm Type
Active Comparator
Arm Title
MLD
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
manual lymphatic drainage
Intervention Description
In addition to conventional treatment for 4 weeks, manual lymph drainage will be applied to the patients.
Intervention Type
Other
Intervention Name(s)
excersize
Intervention Description
upper extremity normal joint range of motion exercise, strengthening exercise, tendon gliding exercises
Primary Outcome Measure Information:
Title
Rheumatoid Arthritis Quality of Life Scale (QOL-RA)
Description
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.
Time Frame
10 minutes
Title
pressure pain threshold
Description
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).
Time Frame
5 minutes
Title
hand grip strength
Description
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.
Time Frame
5 minutes
Title
finger grip strength
Description
Finger pinchmeter (Baseline) will be used to measure finger grip strength.
Time Frame
5 minutes
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Kutahya Health Science University Hospital
City
Kütahya
ZIP/Postal Code
43100
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Manual Lymphatic Drainage for Rheumatoid Arthritis
We'll reach out to this number within 24 hrs