Determination of Chronic Pain, Anxiety, Depression and Perceived Stress in Adults With Temporomandibular Disorders

NCT05183503 | Enrolling By Invitation

• 1 other identifier: WMU3/2021
• Study Type: observational
• Target: 219
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study was to asses levels and relationship of chronic pain, anxiety, depression and perceived stress in TMD patients .

Conditions

Temporomandibular Disorder; Depression; Anxiety; Pain; Stress

Outcome Measures

Primary Outcomes (4)

• Relationship between TMD and pain assessed by Graded Chronic Pain Scale.

  Each participant will fill in Graded Chronic Pain Scale. Scoring Criteria for Grading Chronic Pain Severity: Characteristic Pain Intensity is a 0 to 100 score derived from Questions 1 through 3:Mean (Pain Right Now, Worst Pain, Average Pain) X 10. Disability Score is 0 to 100score derived from Questions 4 through 6:Mean (Daily Activities, Social Activities, Work Activities) X 10. Disability Points: Add the indicated points for Disability Days (Question 7)and for Disability Score. Classification: GRADE 0- No TMD pain in prior 6 months. GRADE I-Low Intensity Characteristic Pain Intensity\<50, Low Disability\<3 Disability Point. GRADE II -High Intensity Characteristic Pain Intensity \>50, LowDisability\<3 Disability Points. GRADE III- High Disability3 to 4 Disability Points, Moderately Limiting (Regardless of Characteristic Pain Intensity). GRADE IV- High Disability 5 to 6 Disability Points, Severely Limiting (Regardless of Characteristic Pain Intensity).

  1.12.2018-1.12.2021

• Relationship between TMD and depression assessed by Patient Health Questionnaire - 9.

  Each participant will fill in Patient Health Questionnaire - 9. PHQ-9 total score for the nine items ranges from 0 to 27.Scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression, respectively.

  1.12.2018-1.12.2021

• Relationship between TMD and perceived stress assessed by Perceived Stress Scale - 10.

  Each participant will fill in Perceived Stress Scale -10. Scores are obtained by reversing the scores on the four positive items, e.g., 0=4, 1=3, 2=2, etc. and then summing across all 10 items. Items 4,5, 7, and 8 are the positively stated items. It can range from 0 to 40. Scores ranging from 0-13 would be considered low stress,14-26 would be considered moderate stress, 27-40 would be considered high perceived stress.

  1.12.2018-1.12.2021

• Relationship between TMD and anxiety assessed by Generalized Anxiety Disorder -7

  Each participant will fill in Generalized Anxiety Disorder -7 that consists of 7 items. Total score ranges 0-21 points. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively.

  1.12.2018-1.12.2021

Study Arms (1)

TMD group

Patients diagnosed with TMD

Diagnostic Test: DC/TMD examination

Interventions

DC/TMD examination DIAGNOSTIC_TEST

Clinical examination by examiners- experienced dentists (minimum 5 years of practice) and trained and calibrated in accordance with the protocol available on the official website of the International Network for Orofacial Pain and Related Disorders Methodology

TMD group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients from the Outpatient Clinic for Temporomandibular Disorders at the Medical University in Wroclaw diagnosed with TMD using Diagnostic Criteria for Temporomandibular Disorders (DC / TMD).

Sponsors & Collaborators

• Wroclaw Medical University: lead

Study Sites (1)

Wroclaw Medical Uniwesity

Wroclaw, Poland

Location

Related Publications (1)

• Wieckiewicz M, Jenca A Jr, Seweryn P, Orzeszek S, Petrasova A, Grychowska N, Winocur-Arias O, Emodi-Perlman A, Kujawa K. Determination of pain intensity, pain-related disability, anxiety, depression, and perceived stress in Polish adults with temporomandibular disorders: A prospective cohort study. Front Integr Neurosci. 2022 Nov 2;16:1026781. doi: 10.3389/fnint.2022.1026781. eCollection 2022.

  PMID: 36407294 DERIVED

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Depression; Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Behavioral Symptoms; Behavior; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: January 10, 2022
• Study Start: November 1, 2018
• Primary Completion: December 1, 2020
• Study Completion: December 31, 2025
• Last Updated: July 16, 2025

Record last verified: 2025-07

Locations

PL (1)