Rheumatoid ArthritisNCT05660629
Mulligan Mobilization in Rheumatoid Hand
A study testing Mulligan Mobilization in people with Rheumatoid Arthritis, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Mulligan Mobilization
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Oct 2023to 12 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Who cannot join
- 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,
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Mulligan Mobilization
- Keywords
- Mulligan Mobilization, Hand Rheumatoid Arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mulligan MobilizationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 weeks
Amount of hypertrophia and effusion in wrist joints
Synovial fluid (area of hypertrophy and effusion, mm2: synovial fluid MCP/region)
Measured: 6 weeks
Distance in wrist joints
the radiographic distance (mm) between the MCP or interphalangeal bone space (joint space MCP/region)
Measured: 6 weeks
DAS-28
High disease activ ity >5.1, low disease activity ≤ 3.2, remission ≤ 2.6
Measured: 6 weeks
Secondary outcomes (5)
Determining the state of pain after treatment
Pain will be assessed using the Mcgill-Melzack Pain Questionnaire
Measured: 6 weeks
Grip force
Hand grip strength will be measured with a pinch meter and a dynamometer
Measured: 6 weeks
Range of Motion
Range of Motion will be measured with goniometer
Measured: 6 weeks
Post-treatment status of disease-related quality of life
Quality of life was assessed using the Rheumatoid Arthritis Quality of Life (RAQoL).
Measured: 6 weeks
Physical, social, and emotional well-being in RA
Arthritis Impact Measurement Scales (AIMS)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start30 Oct 2023
- Primary completion11 Dec 2024
- Study completion12 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirsehir Ahi Evran Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ömer Faruk ÖZÇELEP, Kirsehir Ahi Evran Universitesi
- Investigators
- Figen TUNCAY, Professor, Study director, Kirsehir Ahi Evran Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05660629
- Sponsor's protocol ID
- Ahi Evran University
- Status last verified
- Dec 2024
- First submitted
- 30 Nov 2022
- Last updated
- 17 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sharing of data will be done using the Google Drive link.
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.
PubMed 30879707Villafane 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.
PubMed 23719518Ozcelep 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.
PubMed 35949976Ozcelep 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.
PubMed 41152887
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05660629
- Acronym / sponsor ID
- Ahi Evran University
- Conditions
- Rheumatoid Arthritis
- Keywords
- Mulligan Mobilization, Hand Rheumatoid Arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Kirsehir Ahi Evran UniversitesiUniversity, hospital or other
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- 11 Dec 2024 (actual)
- Study completion
- 12 Dec 2024 (actual)
- First posted
- 21 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mulligan Mobilization | Experimental | Other: Mulligan MobilizationRehabilitation 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) |
| Sham Mobilization | Sham comparator | Other: Mulligan MobilizationParticipants 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. |
| Control | No intervention | –Participants will receive therapeutic patient training consisting of home exercise recommendations, basic disease information, physical activity advice, and joint protection methods. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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,
Key exclusion criteria (3 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mulligan MobilizationMobilization 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. | Other | Mulligan Mobilization, Sham Mobilization |
Primary outcome
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)
Amount of hypertrophia and effusion in wrist joints
Time frame: 6 weeks
Synovial fluid (area of hypertrophy and effusion, mm2: synovial fluid MCP/region)
Distance in wrist joints
Time frame: 6 weeks
the radiographic distance (mm) between the MCP or interphalangeal bone space (joint space MCP/region)
DAS-28
Time frame: 6 weeks
High disease activ ity >5.1, low disease activity ≤ 3.2, remission ≤ 2.6
5 secondary outcomes
Determining the state of pain after treatment
Time frame: 6 weeks
Grip force
Time frame: 6 weeks
Range of Motion
Time frame: 6 weeks
Post-treatment status of disease-related quality of life
Time frame: 6 weeks
Physical, social, and emotional well-being in RA
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Results publication: PubMed 30879707Levitsky 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 publication: PubMed 23719518Villafane 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 publication: PubMed 35949976Ozcelep 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.
- Derived from this study: PubMed 41152887Ozcelep 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.
- Individual participant dataSharing planned: Yes. Sharing of data will be done using the Google Drive link.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Figen TUNCAY, Professor study director
Kirsehir Ahi Evran Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mulligan Mobilization in people with Rheumatoid Arthritis, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Joint activity (time frame: 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05660629, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024.