NCT05660629

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable rheumatoid-arthritis

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 21, 2022

Completed
10 months until next milestone

Study Start

First participant enrolled

October 30, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2024

Completed
Last Updated

December 17, 2024

Status Verified

December 1, 2024

Enrollment Period

1.1 years

First QC Date

November 30, 2022

Last Update Submit

December 13, 2024

Conditions

Keywords

Mulligan MobilizationHand Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (4)

  • 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

  • Amount of hypertrophia and effusion in wrist joints

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

    6 weeks

  • Distance in wrist joints

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

    6 weeks

  • DAS-28

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

    6 weeks

Secondary Outcomes (5)

  • Determining the state of pain after treatment

    6 weeks

  • Grip force

    6 weeks

  • Range of Motion

    6 weeks

  • Post-treatment status of disease-related quality of life

    6 weeks

  • Physical, social, and emotional well-being in RA

    6 weeks

Study Arms (3)

Mulligan Mobilization

EXPERIMENTAL

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

Sham Mobilization

SHAM COMPARATOR

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

Control

NO INTERVENTION

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

Interventions

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.

Mulligan MobilizationSham Mobilization

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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,

You may not qualify if:

  • 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahi Evran University

Kırşehir, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

  • Ozcelep OF, Tunali N, Turhan A, Polat E, Demir C, Gumusay D, Tuncay F. The effect of mobilization with movement on pain, joint distance, effusion area, and inflammation in rheumatoid arthritis: a double-blind randomized controlled clinical trial. J Orthop Surg Res. 2025 Oct 28;20(1):929. doi: 10.1186/s13018-025-06121-3.

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Figen TUNCAY, Professor

    Kirsehir Ahi Evran Universitesi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

November 30, 2022

First Posted

December 21, 2022

Study Start

October 30, 2023

Primary Completion

December 11, 2024

Study Completion

December 12, 2024

Last Updated

December 17, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will share

Sharing of data will be done using the Google Drive link.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
It will be shared for 2 years.

Locations