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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
Selcuk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Effect of Manual Lymphatic Drainage on Upper Extremity Functionality in Rheumatoid Arthritis

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

First Posted
September 1, 2022
Last Updated
December 16, 2022
Sponsor
Selcuk University
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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

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Manual Lymphatic Drainage for Rheumatoid Arthritis

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