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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05660629
Other study ID # Ahi Evran University
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 30, 2023
Est. completion date September 30, 2025

Study information

Verified date October 2023
Source Kirsehir Ahi Evran Universitesi
Contact Ömer Faruk Özçelep, Msc
Phone +90 531 946 3799
Email omer.ozcelep@ahievran.edu.tr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this randomized-controlled study is to learn about the effectiveness of the Mulligan mobilization in rheumatoid hands. The main question it aims to answer are: -Does mulligan mobilization reduce effusion in wrist joints with rheumatoid arthritis? Participants will take Mulligan mobilization application and active ROM exercises for their hands. Researcher will compare treatments group ith sham mobilization.


Description:

Rheumatoid arthritis (RA) is a systemic disease that can lead to chronic pain, bone and soft tissue damage, and disability retirement. Alleviating pain and maintaining joint range of motion in RA are important for reducing disability. Joint mobilizations are manual therapy techniques used to increase range of motion and reduce pain. The aim of this study is to investigate the effects of rheumatoid hand exercise and protective approach and joint mobilization applications on pain, functional status and quality of life.


Recruitment information / eligibility

Status Recruiting
Enrollment 171
Est. completion date September 30, 2025
Est. primary completion date September 30, 2024
Accepts healthy volunteers No
Gender All
Age group 30 Years to 65 Years
Eligibility Inclusion Criteria: - Having been diagnosed with RAS according to ACR and EULAR criteria, - Being under the control of a physiatrist for at least 1 year, - Have not had any upper extremity surgery in the last 6 months - Have the cognitive capacity to understand commands, - Not to be involved in any other rehabilitation program or study, Exclusion Criteria: - Presence of soft tissue injury and chronic bone damage in the hand, - Presence of acute inflammation in any joint in the previous week, - Presence of a degenerative or non-degenerative neurological condition that causes a change in pain perception,

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Mulligan Mobilization
Mobilization with movement (MWM) is the concurrent application of sustained accessory mobilization applied by a therapist and an active physiological movement to end range applied by the patient. Passive end-of-range overpressure, or stretching, is then delivered without pain as a barrier.

Locations

Country Name City State
Turkey Ahi Evran University Kirsehir

Sponsors (1)

Lead Sponsor Collaborator
Kirsehir Ahi Evran Universitesi

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Levitsky A, Kisten Y, Lind S, Nordstrom P, Hultholm H, Lyander J, Hammelin V, Gentline C, Giannakou I, Faustini F, Skillgate E, van Vollenhoven R, Sundberg T. Joint Mobilization of the Hands of Patients With Rheumatoid Arthritis: Results From an Assessor- — View Citation

Ozcelep OF, Ustun I, Algun ZC. Effect of task-oriented training on pain, functionality, and quality of life in rheumatoid arthritis. Turk J Phys Med Rehabil. 2022 Mar 1;68(1):76-83. doi: 10.5606/tftrd.2022.6666. eCollection 2022 Mar. — View Citation

Villafane JH, Cleland JA, Fernandez-de-Las-Penas C. Bilateral sensory effects of unilateral passive accessory mobilization in patients with thumb carpometacarpal osteoarthritis. J Manipulative Physiol Ther. 2013 May;36(4):232-7. doi: 10.1016/j.jmpt.2013.0 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Joint activity Primary outcomes included the automated quantification (Q) of joint activity using color Doppler pixel count calculations (% hyperemia/blood flow activity score within an inflamed joint: color Q-Doppler MCP/region) 6 weeks
Primary Amount of hypertrophia and effusion in wrist joints Synovial fluid (area of hypertrophy and effusion, mm2: synovial fluid MCP/region) 6 weeks
Primary Distance in wrist joints the radiographic distance (mm) between the MCP or interphalangeal bone space (joint space MCP/region) 6 weeks
Primary DAS-28 High disease activ ity >5.1, low disease activity = 3.2, remission = 2.6 6 weeks
Secondary Determining the state of pain after treatment Pain will be assessed using the Mcgill-Melzack Pain Questionnaire 6 weeks
Secondary Grip force Hand grip strength will be measured with a pinch meter and a dynamometer 6 weeks
Secondary Range of Motion Range of Motion will be measured with goniometer 6 weeks
Secondary Post-treatment status of disease-related quality of life Quality of life was assessed using the Rheumatoid Arthritis Quality of Life (RAQoL). 6 weeks
Secondary Physical, social, and emotional well-being in RA Arthritis Impact Measurement Scales (AIMS) 6 weeks
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