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Completed

NCT Number: NCT07171671

Treatment 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • - 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

Treatment and study plan

Exercises

Other

manuel therapy and exercises

Primary outcomes

  1. assessing cervical joint range of motion and joint position sense

    Time frame: 6 weeks

    c-rom

  2. TME Movement Clarity,

    Time frame: 6 weeks

    Millimetre Ruler

  3. pressure pain threshold of muscles

    Time frame: 6 weeks

    Algometer

  4. headache

    Time frame: 6 weeks

    Headache Impact Test- HIT-6

  5. Severity of temporomandibular dysfunction

    Time frame: 6 weeks

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

Sponsors and collaborators

Lead sponsor

Sanko University

Other

Registry information

Official study title

The Effectiveness of Manual Therapy Applications in Individuals With Rheumatoid Arthritis Who Have Temporomandibular Joint Dysfunction

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 12, 2025
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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