NCT07171671

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 26, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 12, 2025

Completed
Last Updated

September 12, 2025

Status Verified

August 1, 2025

Enrollment Period

3 months

First QC Date

August 26, 2025

Last Update Submit

September 8, 2025

Conditions

Keywords

Rheumatoid arthritisTemporomandibular joint dysfunctionManual therapyPain

Outcome Measures

Primary Outcomes (5)

  • assessing cervical joint range of motion and joint position sense

    c-rom

    6 weeks

  • TME Movement Clarity,

    Millimetre Ruler

    6 weeks

  • pressure pain threshold of muscles

    Algometer

    6 weeks

  • headache

    Headache Impact Test- HIT-6

    6 weeks

  • Severity of temporomandibular dysfunction

    Fonseca Anamnestik İndeksi ve Çene Fonksiyon Kısıtlanma Skalası-20(JFLS-20),

    6 weeks

Study Arms (3)

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.

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.

Other: exercises

Control group

EXPERIMENTAL

A second assessment was conducted six weeks after the first assessment. No treatment w

Other: exercises

Interventions

manuel therapy and exercises

Control groupJoint mobilisation groupMyofascial Mobilisation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanko Unıversıty

Gaziantep, Gaziantep, 27090, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Rheumatic DiseasesTemporomandibular Joint DisordersArthritis, RheumatoidPain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesCraniomandibular DisordersMandibular DiseasesJaw DiseasesJoint DiseasesMuscular DiseasesStomatognathic DiseasesArthritisAutoimmune DiseasesImmune System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
director

Study Record Dates

First Submitted

August 26, 2025

First Posted

September 12, 2025

Study Start

October 1, 2024

Primary Completion

January 1, 2025

Study Completion

August 26, 2025

Last Updated

September 12, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations