NCT05529537

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 17, 2022

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

September 1, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 7, 2022

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

December 19, 2022

Status Verified

December 1, 2022

Enrollment Period

1 month

First QC Date

September 1, 2022

Last Update Submit

December 16, 2022

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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.

    10 minutes

  • 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).

    5 minutes

  • 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.

    5 minutes

  • finger grip strength

    Finger pinchmeter (Baseline) will be used to measure finger grip strength.

    5 minutes

Study Arms (2)

control

ACTIVE COMPARATOR
Other: excersize

MLD

EXPERIMENTAL
Other: manual lymphatic drainageOther: excersize

Interventions

In addition to conventional treatment for 4 weeks, manual lymph drainage will be applied to the patients.

MLD

upper extremity normal joint range of motion exercise, strengthening exercise, tendon gliding exercises

MLDcontrol

Eligibility Criteria

Age25 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with RA according to ACR criteria
  • Being between the ages of 18-65
  • Volunteering to participate in the study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kutahya Health Science University Hospital

Kütahya, 43100, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Manual Lymphatic Drainage

Intervention Hierarchy (Ancestors)

MassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsDrainagePhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

September 1, 2022

First Posted

September 7, 2022

Study Start

August 17, 2022

Primary Completion

September 30, 2022

Study Completion

October 1, 2022

Last Updated

December 19, 2022

Record last verified: 2022-12

Locations