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Mulligan Mobilization in Rheumatoid Hand

Primary Purpose

Rheumatoid Arthritis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mulligan Mobilization
Sponsored by
Kirsehir Ahi Evran Universitesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Mulligan Mobilization, Hand Rheumatoid Arthritis

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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,

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Sham Comparator

    No Intervention

    Arm Label

    Mulligan Mobilization

    Sham Mobilization

    Control

    Arm Description

    Rehabilitation Program (Active wrist ROM exercises): Forearm pronation and supination Wrist flexion and extension Wrist flexion and extension (in the form of a fist) MCP Joint Flexion and Extension Thumb IC joint Flexion and Extension Abduction and Adduction of Fingers 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: Carpal Medio-lateral Glide (open kinetics, wrist flexion and extension movement) Carpal Rotation (open kinetics, wrist flexion and extension) Scaphoid Antero-posterior Glide (open kinetics) Metacarpal Antero-posterior Glide (When Clenching) Medio-lateral Glide to PIP-DIP joints (open kinetics, fingers flexed)

    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.

    Participants will receive therapeutic patient training consisting of home exercise recommendations, basic disease information, physical activity advice, and joint protection methods.

    Outcomes

    Primary Outcome Measures

    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)
    Amount of hypertrophia and effusion in wrist joints
    Synovial fluid (area of hypertrophy and effusion, mm2: synovial fluid MCP/region)
    Distance in wrist joints
    the radiographic distance (mm) between the MCP or interphalangeal bone space (joint space MCP/region)
    DAS-28
    High disease activ ity >5.1, low disease activity ≤ 3.2, remission ≤ 2.6

    Secondary Outcome Measures

    Determining the state of pain after treatment
    Pain will be assessed using the Mcgill-Melzack Pain Questionnaire
    Grip force
    Hand grip strength will be measured with a pinch meter and a dynamometer
    Range of Motion
    Range of Motion will be measured with goniometer
    Post-treatment status of disease-related quality of life
    Quality of life was assessed using the Rheumatoid Arthritis Quality of Life (RAQoL).
    Physical, social, and emotional well-being in RA
    Arthritis Impact Measurement Scales (AIMS)

    Full Information

    First Posted
    November 30, 2022
    Last Updated
    May 15, 2023
    Sponsor
    Kirsehir Ahi Evran Universitesi
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05660629
    Brief Title
    Mulligan Mobilization in Rheumatoid Hand
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 30, 2023 (Anticipated)
    Primary Completion Date
    September 30, 2024 (Anticipated)
    Study Completion Date
    September 30, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Kirsehir Ahi Evran Universitesi

    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
    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.
    Detailed 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rheumatoid Arthritis
    Keywords
    Mulligan Mobilization, Hand Rheumatoid Arthritis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    171 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Mulligan Mobilization
    Arm Type
    Experimental
    Arm Description
    Rehabilitation Program (Active wrist ROM exercises): Forearm pronation and supination Wrist flexion and extension Wrist flexion and extension (in the form of a fist) MCP Joint Flexion and Extension Thumb IC joint Flexion and Extension Abduction and Adduction of Fingers 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: Carpal Medio-lateral Glide (open kinetics, wrist flexion and extension movement) Carpal Rotation (open kinetics, wrist flexion and extension) Scaphoid Antero-posterior Glide (open kinetics) Metacarpal Antero-posterior Glide (When Clenching) Medio-lateral Glide to PIP-DIP joints (open kinetics, fingers flexed)
    Arm Title
    Sham Mobilization
    Arm Type
    Sham Comparator
    Arm Description
    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.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Participants will receive therapeutic patient training consisting of home exercise recommendations, basic disease information, physical activity advice, and joint protection methods.
    Intervention Type
    Other
    Intervention Name(s)
    Mulligan Mobilization
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Joint activity
    Description
    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)
    Time Frame
    6 weeks
    Title
    Amount of hypertrophia and effusion in wrist joints
    Description
    Synovial fluid (area of hypertrophy and effusion, mm2: synovial fluid MCP/region)
    Time Frame
    6 weeks
    Title
    Distance in wrist joints
    Description
    the radiographic distance (mm) between the MCP or interphalangeal bone space (joint space MCP/region)
    Time Frame
    6 weeks
    Title
    DAS-28
    Description
    High disease activ ity >5.1, low disease activity ≤ 3.2, remission ≤ 2.6
    Time Frame
    6 weeks
    Secondary Outcome Measure Information:
    Title
    Determining the state of pain after treatment
    Description
    Pain will be assessed using the Mcgill-Melzack Pain Questionnaire
    Time Frame
    6 weeks
    Title
    Grip force
    Description
    Hand grip strength will be measured with a pinch meter and a dynamometer
    Time Frame
    6 weeks
    Title
    Range of Motion
    Description
    Range of Motion will be measured with goniometer
    Time Frame
    6 weeks
    Title
    Post-treatment status of disease-related quality of life
    Description
    Quality of life was assessed using the Rheumatoid Arthritis Quality of Life (RAQoL).
    Time Frame
    6 weeks
    Title
    Physical, social, and emotional well-being in RA
    Description
    Arthritis Impact Measurement Scales (AIMS)
    Time Frame
    6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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,
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ömer Faruk Özçelep, Msc
    Phone
    +90 531 946 3799
    Email
    omer.ozcelep@ahievran.edu.tr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Figen TUNCAY, Professor
    Organizational Affiliation
    Kirsehir Ahi Evran Universitesi
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Sharing of data will be done using the Google Drive link.
    IPD Sharing Time Frame
    It will be shared for 2 years.
    Citations:
    PubMed Identifier
    30879707
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    23719518
    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.2013.05.008. Epub 2013 May 27.
    Results Reference
    result
    PubMed Identifier
    35949976
    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.
    Results Reference
    result

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    Mulligan Mobilization in Rheumatoid Hand

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