Rheumatic DiseasesNCT07171671
Treatment in Individuals With Rheumatoid Arthritis Who Have Temporomandibular Joint Dysfunction
A study testing exercises in people with Rheumatic Diseases and Temporomandibular Joint Dysfunction, run by Sanko University at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to investigate the effect of manual therapy applications on pain, range of motion and joint position sense in individuals with rheumatoid arthritis who have temporomandibular joint dysfunction. The 57 patients included in the study were divided into 3 groups by simple randomization. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rheumatic Diseases, Temporomandibular Joint Dysfunction, Manuel Therapy
- What is being tested?
- exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2024to 26 Aug 2025
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be aged between 18 and 65
- Have been diagnosed with rheumatoid arthritis according to the ACR/EULAR 2010 criteria
- Be in the chronic phase of the disease
- Have temporomandibular joint dysfunction according to the RDC/TMD criteria
- Have intact cognitive functions
- Individuals who agree to participate in the study and sign the informed consent form
Who cannot join
- - Maksillofasiyal travma ve cerrahi öyküsü olanlar
- Son 6 ayda ortodontik tedavi öyküsü olanlar
- Trigeminal nevralji ve/veya fasiyal sinir paralizisi öyküsü olanlar
- Romatoid Artrit dışında ek bir romatolojik hastalığı olanlar
- Ağız içi splint kullanıyor olmak
- Protez diş kullanımı ve molar dişlerde eksiklik
- Servikal bölgeye ve temporomandibular eklem disfonksiyonuna yönelik son 6 ayda Manuel - Terapi, enjeksiyon vb. benzeri tedavi görmüş olmak
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Manual Therapy Applications in Individuals With Rheumatoid Arthritis Who Have Temporomandibular Joint Dysfunction
This study was conducted to investigate the effect of manual therapy applications on pain, range of motion and joint position sense in individuals with rheumatoid arthritis who have temporomandibular joint dysfunction. The 57 patients included in the study were divided into 3 groups by simple randomization. Group 1 received myofascial mobilization of masticatory muscles and group 2 received temporomandibular joint mobilization twice a week for 6 weeks. The control group received no treatment. The groups were evaluated twice, before and after treatment. The control group underwent a second evaluation 6 weeks after the first evaluation. C-ROM was used to evaluate cervical range of motion and joint position sensation, millimeter ruler was used to evaluate TMJ range of motion, Algometer was used to evaluate pressure pain threshold of muscles, Headache Impact Test-HIT-6 was used for headache, Fonseca Anamnestic Index (FAI) and Jaw Function Limitation Scale-20 (JFLS-20) were used for temporomandibular dysfunction severity, Generalized Anxiety Disorder-7 was used for emotional state. In the cervical range of motion, the myofascial group showed significant normal range of motion improvements only in the flexion and lateral flexion directions, while no benefit was obtained in the extension and rotation directions. In the joint mobilization group, significant improvements were observed in all directions (flexion, extension, lateral flexion, rotation) (p<0.05). In the evaluation of cervical joint position sensation, improvements in joint position sensation were observed in all directions in the joint mobilization group. In the myofascial mobilization group, limited improvements were observed in some directions, but most of the variables decreased (p<0.05). In the measurement of pressure pain thresholds, a decrease was observed in the two treatment groups before and after treatment and compared to the control group (p<0.05), while no statistically significant difference was detected in any variable in the comparison between the treatment groups (P>0.05). Patients in the two treatment groups showed an increase in mandibular range of motion in all directions compared to both the pre- and post-treatment and control groups (p<0.05), while no statistically significant difference was detected in any variable in the comparison between the treatment groups (P>0.05). Joint mobilization and myofascial mobilization applications significantly reduced headache, anxiety severity and improved jaw function. There was a significant decrease in HIT-6, GAD-7, JFLS-20 total, JFLS-20 mastication, JFLS-20 mobility, JFLS-20 communication and Fonseca scores in both groups (p<0.05), while no statistically significant difference was found in any variable in the comparison of treatment groups (P>0.05). It was observed that myofascial mobilization and joint mobilization applications had positive effects on pain, mandibular range of motion, cervical joint range of motion and joint position sensation, jaw functions, headache and anxiety level in individuals with rheumatoid arthritis with temporomandibular joint dysfunction.
Read the detailed description
This study was conducted to investigate the effect of manual therapy applications on pain, range of motion and joint position sense in individuals with rheumatoid arthritis who have temporomandibular joint dysfunction. The 57 patients included in the study were divided into 3 groups by simple randomization. Group 1 received myofascial mobilization of masticatory muscles and group 2 received temporomandibular joint mobilization twice a week for 6 weeks. The control group received no treatment. The groups were evaluated twice, before and after treatment. The control group underwent a second evaluation 6 weeks after the first evaluation. C-ROM was used to evaluate cervical range of motion and joint position sensation, millimeter ruler was used to evaluate TMJ range of motion, Algometer was used to evaluate pressure pain threshold of muscles, Headache Impact Test-HIT-6 was used for headache, Fonseca Anamnestic Index (FAI) and Jaw Function Limitation Scale-20 (JFLS-20) were used for temporomandibular dysfunction severity, Generalized Anxiety Disorder-7 was used for emotional state. In the cervical range of motion, the myofascial group showed significant normal range of motion improvements only in the flexion and lateral flexion directions, while no benefit was obtained in the extension and rotation directions. In the joint mobilization group, significant improvements were observed in all directions (flexion, extension, lateral flexion, rotation) (p<0.05). In the evaluation of cervical joint position sensation, improvements in joint position sensation were observed in all directions in the joint mobilization group. In the myofascial mobilization group, limited improvements were observed in some directions, but most of the variables decreased (p<0.05). In the measurement of pressure pain thresholds, a decrease was observed in the two treatment groups before and after treatment and compared to the control group (p<0.05), while no statistically significant difference was detected in any variable in the comparison between the treatment groups (P>0.05). Patients in the two treatment groups showed an increase in mandibular range of motion in all directions compared to both the pre- and post-treatment and control groups (p<0.05), while no statistically significant difference was detected in any variable in the comparison between the treatment groups (P>0.05). Joint mobilization and myofascial mobilization applications significantly reduced headache, anxiety severity and improved jaw function. There was a significant decrease in HIT-6, GAD-7, JFLS-20 total, JFLS-20 mastication, JFLS-20 mobility, JFLS-20 communication and Fonseca scores in both groups (p<0.05), while no statistically significant difference was found in any variable in the comparison of treatment groups (P>0.05). It was observed that myofascial mobilization and joint mobilization applications had positive effects on pain, mandibular range of motion, cervical joint range of motion and joint position sensation, jaw functions, headache and anxiety level in individuals with rheumatoid arthritis with temporomandibular joint dysfunction.
- Being tested
- exercises
- Keywords
- Rheumatoid arthritis, Temporomandibular joint dysfunction, Manual therapy, Pain
- Medical subject headings
- Rheumatic Diseases, Temporomandibular Joint Disorders, Arthritis, Rheumatoid, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercisesOther
manuel therapy and exercises
| Study group | Role | What they receive |
|---|---|---|
| Myofascial Mobilisation | Experimental | Myofascial mobilisation treatment was carried out in three stages. In these stages, trigger point therapy was first applied, followed by myofascial release and finally the muscle energy technique for the masticatory muscles. The procedures were performed twice a week for six weeks. The sessions lasted an average of 30 minutes. Receives: Other: exercises |
| Joint mobilisation group | Experimental | Joint mobilisation treatment was carried out in four stages. In these stages, caudal translation was performed first, followed by anterior translation, then mediolateral translation, and finally ventro-caudal translation. The procedures were performed twice a week for six weeks. The applications lasted an average of 30 minutes. Receives: Other: exercises |
| Control group | Experimental | A second assessment was conducted six weeks after the first assessment. No treatment w Receives: Other: exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessing cervical joint range of motion and joint position sense
c-rom
Measured: 6 weeks
TME Movement Clarity,
Millimetre Ruler
Measured: 6 weeks
pressure pain threshold of muscles
Algometer
Measured: 6 weeks
headache
Headache Impact Test- HIT-6
Measured: 6 weeks
Severity of temporomandibular dysfunction
Fonseca Anamnestik İndeksi ve Çene Fonksiyon Kısıtlanma Skalası-20(JFLS-20),
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 posted12 Sep 2025
- Study start1 Oct 2024
- Primary completion1 Jan 2025
- Study completion26 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatic DiseasesStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanko University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hakan Polat, Sanko University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07171671
- Sponsor's protocol ID
- hakanpolat4
- Status last verified
- Aug 2025
- First submitted
- 26 Aug 2025
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aktas K, Polat H, Maden T, Kocyigit BF. Comparison of the Effects of Different Manual Therapy Techniques on Mandibular Mobility, Cervical Joint Position Sense, Jaw Function and Anxiety Levels in Individuals With Rheumatoid Arthritis and Temporomandibular Disorders: A Randomized Controlled Trial. J Oral Rehabil. 2026 Sep;53(9):1637-1649. doi: 10.1111/joor.70218. Epub 2026 May 23.
PubMed 42175667
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Manual Therapy Applications in Individuals With Rheumatoid Arthritis Who Have Temporomandibular Joint Dysfunction
- ClinicalTrials.gov ID
- NCT07171671
- Acronym / sponsor ID
- hakanpolat4
- Keywords
- Rheumatoid arthritis, Temporomandibular joint dysfunction, Manual therapy, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Sanko UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 26 Aug 2025 (actual)
- First posted
- 12 Sep 2025 (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.
This study was conducted to investigate the effect of manual therapy applications on pain, range of motion and joint position sense in individuals with rheumatoid arthritis who have temporomandibular joint dysfunction. The 57 patients included in the study were divided into 3 groups by simple randomization. Group 1 received myofascial mobilization of masticatory muscles and group 2 received temporomandibular joint mobilization twice a week for 6 weeks. The control group received no treatment. The groups were evaluated twice, before and after treatment. The control group underwent a second evaluation 6 weeks after the first evaluation. C-ROM was used to evaluate cervical range of motion and joint position sensation, millimeter ruler was used to evaluate TMJ range of motion, Algometer was used to evaluate pressure pain threshold of muscles, Headache Impact Test-HIT-6 was used for headache, Fonseca Anamnestic Index (FAI) and Jaw Function Limitation Scale-20 (JFLS-20) were used for temporomandibular dysfunction severity, Generalized Anxiety Disorder-7 was used for emotional state. In the cervical range of motion, the myofascial group showed significant normal range of motion improvements only in the flexion and lateral flexion directions, while no benefit was obtained in the extension and rotation directions. In the joint mobilization group, significant improvements were observed in all directions (flexion, extension, lateral flexion, rotation) (p<0.05). In the evaluation of cervical joint position sensation, improvements in joint position sensation were observed in all directions in the joint mobilization group. In the myofascial mobilization group, limited improvements were observed in some directions, but most of the variables decreased (p<0.05). In the measurement of pressure pain thresholds, a decrease was observed in the two treatment groups before and after treatment and compared to the control group (p<0.05), while no statistically significant difference was detected in any variable in the comparison between the treatment groups (P>0.05). Patients in the two treatment groups showed an increase in mandibular range of motion in all directions compared to both the pre- and post-treatment and control groups (p<0.05), while no statistically significant difference was detected in any variable in the comparison between the treatment groups (P>0.05). Joint mobilization and myofascial mobilization applications significantly reduced headache, anxiety severity and improved jaw function. There was a significant decrease in HIT-6, GAD-7, JFLS-20 total, JFLS-20 mastication, JFLS-20 mobility, JFLS-20 communication and Fonseca scores in both groups (p<0.05), while no statistically significant difference was found in any variable in the comparison of treatment groups (P>0.05). It was observed that myofascial mobilization and joint mobilization applications had positive effects on pain, mandibular range of motion, cervical joint range of motion and joint position sensation, jaw functions, headache and anxiety level in individuals with rheumatoid arthritis with temporomandibular joint dysfunction.
Detailed description
This study was conducted to investigate the effect of manual therapy applications on pain, range of motion and joint position sense in individuals with rheumatoid arthritis who have temporomandibular joint dysfunction. The 57 patients included in the study were divided into 3 groups by simple randomization. Group 1 received myofascial mobilization of masticatory muscles and group 2 received temporomandibular joint mobilization twice a week for 6 weeks. The control group received no treatment. The groups were evaluated twice, before and after treatment. The control group underwent a second evaluation 6 weeks after the first evaluation. C-ROM was used to evaluate cervical range of motion and joint position sensation, millimeter ruler was used to evaluate TMJ range of motion, Algometer was used to evaluate pressure pain threshold of muscles, Headache Impact Test-HIT-6 was used for headache, Fonseca Anamnestic Index (FAI) and Jaw Function Limitation Scale-20 (JFLS-20) were used for temporomandibular dysfunction severity, Generalized Anxiety Disorder-7 was used for emotional state. In the cervical range of motion, the myofascial group showed significant normal range of motion improvements only in the flexion and lateral flexion directions, while no benefit was obtained in the extension and rotation directions. In the joint mobilization group, significant improvements were observed in all directions (flexion, extension, lateral flexion, rotation) (p<0.05). In the evaluation of cervical joint position sensation, improvements in joint position sensation were observed in all directions in the joint mobilization group. In the myofascial mobilization group, limited improvements were observed in some directions, but most of the variables decreased (p<0.05). In the measurement of pressure pain thresholds, a decrease was observed in the two treatment groups before and after treatment and compared to the control group (p<0.05), while no statistically significant difference was detected in any variable in the comparison between the treatment groups (P>0.05). Patients in the two treatment groups showed an increase in mandibular range of motion in all directions compared to both the pre- and post-treatment and control groups (p<0.05), while no statistically significant difference was detected in any variable in the comparison between the treatment groups (P>0.05). Joint mobilization and myofascial mobilization applications significantly reduced headache, anxiety severity and improved jaw function. There was a significant decrease in HIT-6, GAD-7, JFLS-20 total, JFLS-20 mastication, JFLS-20 mobility, JFLS-20 communication and Fonseca scores in both groups (p<0.05), while no statistically significant difference was found in any variable in the comparison of treatment groups (P>0.05). It was observed that myofascial mobilization and joint mobilization applications had positive effects on pain, mandibular range of motion, cervical joint range of motion and joint position sensation, jaw functions, headache and anxiety level in individuals with rheumatoid arthritis with temporomandibular joint dysfunction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Myofascial Mobilisation | Experimental | Other: exercisesMyofascial mobilisation treatment was carried out in three stages. In these stages, trigger point therapy was first applied, followed by myofascial release and finally the muscle energy technique for the masticatory muscles. The procedures were performed twice a week for six weeks. The sessions lasted an average of 30 minutes. |
| Joint mobilisation group | Experimental | Other: exercisesJoint mobilisation treatment was carried out in four stages. In these stages, caudal translation was performed first, followed by anterior translation, then mediolateral translation, and finally ventro-caudal translation. The procedures were performed twice a week for six weeks. The applications lasted an average of 30 minutes. |
| Control group | Experimental | Other: exercisesA second assessment was conducted six weeks after the first assessment. No treatment w |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be aged between 18 and 65
- Have been diagnosed with rheumatoid arthritis according to the ACR/EULAR 2010 criteria
- Be in the chronic phase of the disease
- Have temporomandibular joint dysfunction according to the RDC/TMD criteria
- Have intact cognitive functions
Key exclusion criteria (7 listed)
- - Maksillofasiyal travma ve cerrahi öyküsü olanlar
- Son 6 ayda ortodontik tedavi öyküsü olanlar
- Trigeminal nevralji ve/veya fasiyal sinir paralizisi öyküsü olanlar
- Romatoid Artrit dışında ek bir romatolojik hastalığı olanlar
- Ağız içi splint kullanıyor olmak
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 |
|---|---|---|
| exercisesmanuel therapy and exercises | Other | Control group, Joint mobilisation group, Myofascial Mobilisation |
Primary outcome
assessing cervical joint range of motion and joint position sense
Time frame: 6 weeks
c-rom
TME Movement Clarity,
Time frame: 6 weeks
Millimetre Ruler
pressure pain threshold of muscles
Time frame: 6 weeks
Algometer
headache
Time frame: 6 weeks
Headache Impact Test- HIT-6
Severity of temporomandibular dysfunction
Time frame: 6 weeks
Fonseca Anamnestik İndeksi ve Çene Fonksiyon Kısıtlanma Skalası-20(JFLS-20),
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 12 Sep 2025.
- Derived from this study: PubMed 42175667Aktas K, Polat H, Maden T, Kocyigit BF. Comparison of the Effects of Different Manual Therapy Techniques on Mandibular Mobility, Cervical Joint Position Sense, Jaw Function and Anxiety Levels in Individuals With Rheumatoid Arthritis and Temporomandibular Disorders: A Randomized Controlled Trial. J Oral Rehabil. 2026 Sep;53(9):1637-1649. doi: 10.1111/joor.70218. Epub 2026 May 23.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercises in people with Rheumatic Diseases and Temporomandibular Joint Dysfunction, run by Sanko University 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 6 inclusion and 7 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 12 Sep 2025. 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. 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?
assessing cervical joint range of motion and joint position sense (time frame: 6 weeks). The study lists 5 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 NCT07171671, which also lists 1 linked publication.
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 12 Sep 2025.