- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05660629
Mulligan Mobilization in Rheumatoid Hand
Comparison of the Effects of Exercise and Protective Approach in the Rheumatoid Hand and Joint Mobilization Applications on Pain, Functional Status and Quality of Life
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Kırşehir, Turkey
- Ahi Evran University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mulligan Mobilization
Rehabilitation Program (Active wrist ROM exercises):
These exercises will be performed by the physiotherapist in the form of 5 seconds of movement / 15 seconds of rest, 10 repetitions a day, 5 days a week for 6 weeks. 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.
|
|
Sham Comparator: Sham Mobilization
Participants will receive sham mobilization in addition to the ROM exercises given in the Mulligan group.
Sham mobilization will be done in the same position as Mulligan but without any glide force.
|
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.
|
|
No Intervention: Control
Participants will receive therapeutic patient training consisting of home exercise recommendations, basic disease information, physical activity advice, and joint protection methods.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Joint activity
Time Frame: 6 weeks
|
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
|
|
Amount of hypertrophia and effusion in wrist joints
Time Frame: 6 weeks
|
Synovial fluid (area of hypertrophy and effusion, mm2: synovial fluid MCP/region)
|
6 weeks
|
|
Distance in wrist joints
Time Frame: 6 weeks
|
the radiographic distance (mm) between the MCP or interphalangeal bone space (joint space MCP/region)
|
6 weeks
|
|
DAS-28
Time Frame: 6 weeks
|
High disease activ ity >5.1, low disease activity ≤ 3.2, remission ≤ 2.6
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Determining the state of pain after treatment
Time Frame: 6 weeks
|
Pain will be assessed using the Mcgill-Melzack Pain Questionnaire
|
6 weeks
|
|
Grip force
Time Frame: 6 weeks
|
Hand grip strength will be measured with a pinch meter and a dynamometer
|
6 weeks
|
|
Range of Motion
Time Frame: 6 weeks
|
Range of Motion will be measured with goniometer
|
6 weeks
|
|
Post-treatment status of disease-related quality of life
Time Frame: 6 weeks
|
Quality of life was assessed using the Rheumatoid Arthritis Quality of Life (RAQoL).
|
6 weeks
|
|
Physical, social, and emotional well-being in RA
Time Frame: 6 weeks
|
Arthritis Impact Measurement Scales (AIMS)
|
6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Figen TUNCAY, Professor, Kirsehir Ahi Evran Universitesi
Publications and helpful links
General Publications
- 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-Blinded, Randomized Crossover Trial. J Manipulative Physiol Ther. 2019 Jan;42(1):34-46. doi: 10.1016/j.jmpt.2018.04.007. Epub 2019 Mar 14.
- 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.2013.05.008. Epub 2013 May 27.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ahi Evran University
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Rheumatoid Arthritis
-
Janssen Research & Development, LLCWithdrawnActive Rheumatoid Arthritis; Rheumatoid Arthritis
-
Centocor, Inc.CompletedRheumatoid Arthritis, Juvenile
-
Yuanyuan ZhangRecruitingRheumatoid Arthritis (RA) | Rheumatoid Arthritis-Associated Interstitial Lung Disease | Difficult-to-Treat Rheumatoid ArthritisChina
-
AmgenTerminated
-
Children's Hospital Medical Center, CincinnatiNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)CompletedJuvenile Rheumatoid ArthritisUnited States
-
AmgenImmunex CorporationCompletedJuvenile Rheumatoid Arthritis
-
Richard Burt, MDTerminated
-
Assistance Publique - Hôpitaux de ParisSociete Francaise de RhumatologieRecruiting
-
University Hospital, ToulouseCompletedRheumatoId ArthritisFrance
-
Amsterdam UMC, location VUmcEuropean CommissionCompletedRheumatoId ArthritisNetherlands, Germany, Portugal, Italy, Hungary, Romania, Slovakia
Clinical Trials on Mulligan Mobilization
-
Gazi UniversityNot yet recruitingNon-specific Low Back Pain (NSLBP)Turkey (Türkiye)
-
Riphah International UniversityCompleted
-
Riphah International UniversityCompletedRunner's KneePakistan
-
Anas Radi Hassan AlashramNot yet recruiting
-
Imam Abdulrahman Bin Faisal UniversityUnknownNonspecific Neck PainSaudi Arabia
-
Riphah International UniversityCompletedAdhesive Capsulitis of ShoulderPakistan
-
Karabuk UniversityCompletedNeck Pain | Disability Physical | KinesiophobiaTurkey
-
Foundation University IslamabadRecruitingTemporomandibular Joint DysfunctionPakistan
-
Riphah International UniversityRecruitingForward Head Posture | Neck SyndromePakistan
-
Riphah International UniversityRecruitingDe Quervain SyndromePakistan