Mulligan Mobilization in Rheumatoid Hand

Sponsor
Kirsehir Ahi Evran Universitesi (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05660629
Collaborator
(none)
171
3
12

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Mulligan Mobilization
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
171 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Mar 30, 2023
Anticipated Primary Completion Date :
Mar 30, 2024
Anticipated Study Completion Date :
Mar 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Mulligan Mobilization

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)

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.

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.

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.

No Intervention: Control

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

Outcome Measures

Primary Outcome Measures

  1. Joint activity [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)

  2. Amount of hypertrophia and effusion in wrist joints [6 weeks]

    Synovial fluid (area of hypertrophy and effusion, mm2: synovial fluid MCP/region)

  3. Distance in wrist joints [6 weeks]

    the radiographic distance (mm) between the MCP or interphalangeal bone space (joint space MCP/region)

  4. DAS-28 [6 weeks]

    High disease activ ity >5.1, low disease activity ≤ 3.2, remission ≤ 2.6

Secondary Outcome Measures

  1. Determining the state of pain after treatment [6 weeks]

    Pain will be assessed using the Mcgill-Melzack Pain Questionnaire

  2. Grip force [6 weeks]

    Hand grip strength will be measured with a pinch meter and a dynamometer

  3. Range of Motion [6 weeks]

    Range of Motion will be measured with goniometer

  4. Post-treatment status of disease-related quality of life [6 weeks]

    Quality of life was assessed using the Rheumatoid Arthritis Quality of Life (RAQoL).

  5. Physical, social, and emotional well-being in RA [6 weeks]

    Arthritis Impact Measurement Scales (AIMS)

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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,

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Kirsehir Ahi Evran Universitesi

Investigators

  • Study Director: Figen TUNCAY, Professor, Kirsehir Ahi Evran Universitesi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ömer Faruk ÖZÇELEP, Lecturer, Kirsehir Ahi Evran Universitesi
ClinicalTrials.gov Identifier:
NCT05660629
Other Study ID Numbers:
  • Ahi Evran University
First Posted:
Dec 21, 2022
Last Update Posted:
Jan 23, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ömer Faruk ÖZÇELEP, Lecturer, Kirsehir Ahi Evran Universitesi
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 23, 2023