NCT07385781

Brief Summary

Temporomandibular joint disorder poses an intricate etiology. Biomechanical, neuromuscular and psychosocial factors may contribute to the disorder among which psychological and psychosocial disturbances have shown strong direct or indirect contribution to the disease especially when the pain is of muscular origin.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
4mo left

Started Mar 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Study Progress37%
Mar 2026Aug 2026

First Submitted

Initial submission to the registry

December 11, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 4, 2026

Completed
25 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2026

Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

4 months

First QC Date

December 11, 2025

Last Update Submit

March 16, 2026

Conditions

Keywords

AnxietyDepressionmyofascial facial painPerceived stressSomatization

Outcome Measures

Primary Outcomes (1)

  • Psychosomatic symptom burden

    Psychosomatic symptom burden is defined as the overall severity and frequency of physical symptoms that are influenced or maintained by psychological factors. It will be assessed using a validated self-report questionnaire that captures multiple somatic symptom domains (e.g., pain, gastrointestinal, cardiovascular, and fatigue-related symptoms). Higher scores indicate a greater psychosomatic symptom burden.

    2 months

Study Arms (2)

Case

A total of 300 participants aged between 20 and 60 years were recruited using survivor sampling, consisting of 150 patients with a confirmed diagnosis of myofascial pain and temporomandibular joint dysfunction (TMD) and 150 age- and gender-matched healthy controls

Other: Casr

Control

A total of 300 participants aged between 20 and 60 years were recruited using survivor sampling, consisting of 150 patients with a confirmed diagnosis of myofascial pain and temporomandibular joint dysfunction (TMD) and 150 age- and gender-matched healthy controls

Other: Casr

Interventions

CasrOTHER

case study participants

CaseControl

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Temporomandibular joint dysfunction patient

You may qualify if:

  • diagnosed patients with myofascial pain and TMD for at least six months based on Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD), Axis I, age between 20 and 60 years, literate and able to comprehend the questionnaire no prior psychological treatment for pain.

You may not qualify if:

  • age \<20 or \>60 years, low literacy (less than five years of formal education), history of major psychiatric or neurological disorders, diagnosed joint pathologies (e.g., arthritis, disc displacement with reduction), history of migraine or facial trauma, drug dependency and pregnancy or current use of psychotropic medication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bahria University

Karachi, Pakistan

Location

Related Publications (2)

  • 1. Szarejko KD, Gołębiewska M, Lukomska-Szymanska M, Kuć J. Stress experience, depression and neck disability in patients with temporomandibular disorder-myofascial pain with referral. Journal of Clinical Medicine. 2023;12(5):1988. 2. Kuć J, Szarejko KD, Maciejczyk M, Dymicka-Piekarska V, Żendzian-Piotrowska M, Zalewska A. Oxidative imbalance as a co-player in jaw functional limitations and biopsychosocial profile in patients with temporomandibular disorder-Myofascial pain with referral. Frontiers in Neurology. 2025;15:1509845. 3. Gomes AKP, Ximenes TA, Fonseca APR, de Barros Silva PG, Magalhães IA, da Silva Rodrigues AK, et al. Relationship between temporomandibular joint dysfunctions and psychosomatic factors. Revista Eletrônica Acervo Saúde. 2024;24(5):e16019-e. 4. Syroishko M, Kostiuk T. Dysfunction of the temporomandibular joints associated with post-traumatic stress disorders in patients. Reports of Vinnytsia National Medical University. 2023;27(2):253-7. 5. Matos M, Thumati P, Sutter B, Ruiz-Velasco G, Goldberg J, Booth J, et al. Are Temporomandibular Disorders Really Somatic Symptom Disorders? Part II-Joint Vibration Analysis of the Temporomandibular Joint. Advanced Dental Technologies & Techniques. 2021. 6. Patil DJ, Dheer DS, Puri G, Konidena A, Dixit A, Gupta R. Psychological appraisal in temporomandibular disorders: A cross-sectional study. Indian Journal of pain. 2016;30(1):13-8. 7. Canales GDLT, Guarda-Nardini L, Rizzatti-Barbosa CM, Conti PCR, Manfredini D. Distribution of depression, somatization and pain-related impairment in patients with chronic temporomandibular disorders. Journal of Applied Oral Science. 2019;27:e20180210. 8. Urits I, Charipova K, Gress K, Schaaf AL, Gupta S, Kiernan HC, et al. Treatment and management of myofascial pain syndrome. Best Practice & Research Clinical Anaesthesiology. 2020;34(3):427-48. 9. Cao Q-W, Peng B-G, Wang L, Huang Y-Q, Jia D-L, Jiang H, et al. Expert consensus on the diagnosis and treatment of myofascial pai

    RESULT
  • Szarejko KD, Golebiewska M, Lukomska-Szymanska M, Kuc J. Stress Experience, Depression and Neck Disability in Patients with Temporomandibular Disorder-Myofascial Pain with Referral. J Clin Med. 2023 Mar 2;12(5):1988. doi: 10.3390/jcm12051988.

MeSH Terms

Conditions

Temporomandibular Joint DisordersAnxiety DisordersDepression

Interventions

Receptors, Calcium-Sensing

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic DiseasesMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Receptors, G-Protein-CoupledReceptors, Cell SurfaceMembrane ProteinsProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Rida Zulfiqar

    Bahria University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

rida Zulfiqar, BDS

CONTACT

Arsalan Khalid, BDS

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Registrar

Study Record Dates

First Submitted

December 11, 2025

First Posted

February 4, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

August 30, 2026

Last Updated

March 18, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, ICF, CSR
Time Frame
jan 2026-Dec2026

Locations