Individualized Assessment and Treatment for TMD

NCT04376333 | Active Not Recruiting DMC

• 2 other identifiers: 20-045-2U01DE028520
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

Temporomandibular/orofacial pain disorders (TMD) are a group of painful conditions with multiple determinants.This proposal has two main goals: 1) to test a highly individualized, adaptive treatment for TMD that has potential to be more effective than other psychosocial treatments; and 2) to discover the mechanisms by which psychosocial treatments work in chronic pain. TMD patients (N=160) will be randomized to receive standard care (STD) + an individualized assessment and treatment program (IATP) or to standard care + conventional cognitive-behavioral treatment (STD+CBT). It is expected that the STD+IATP treatment will yield lower pain, depression and interference scores over time than STD+CBT, and that changes in coping ability will mediate the treatment effects on outcomes.

Conditions

Orofacial Pain; Temporomandibular Joint Disorders

Keywords

TMD; orofacial pain; chronic pain; coping; ecological momentary assessment

Outcome Measures

Primary Outcomes (3)

• Change in pain from baseline as measured by the 11-point Characteristic Pain Intensity Index at each follow-up point

  Characteristic Pain Intensity will be calculated by averaging the ratings of current pain, average pain, and worst pain in the past week from the Graded Chronic Pain Scale (GCPS; Von Korff et al., 1992). Each item is scored from 0 -10.

  Baseline and at the follow-up points 7 weeks (posttreatment), 3 months, 6 months, 9 months, and 12 months

• Change in interference with activities from Baseline as measured at all follow-up points by the 10-item Interference scale from the Multidimensional Pain Inventory (MPI; Kerns, Turk, & Rudy, 1985).

  The MPI is a widely used, validated self-report inventory assessing various areas of impact by chronic pain. The Interference scale iconsists of 10 itmes assessing various areas of life that may have been affected or changed by chronic pain. Each item is scored from 0 to 6 (No change to Extreme Change).

  Baseline and at the follow-up points: 7 weeks (posttreatment), 3 months, 6 months, 9 months, and 12 months

• Change in Depressive Symptoms from baseline as measured by the 20-item Center for Epidemiological Studies Depression scale Revised (CESD-R) at each follow-up point

  CESD-R is a 20-item scale assessing depressive symptoms. It was developed by the Center for Epidemiologic Studies (Radlof, 1977), and has shown high reliability and validity. The 20 items describe behaviors or feelings characteristic of depression that people may have. Respondents are instructed to indicate the extent they experience each item on a scale from Rarely to Most of the Time. The total score ranges from 0 to 80, with higher scores indicting mroe severe depressive symptomatology.

  Baseline and at the follow-up points 7 weeks (posttreatment), 3 months, 6 months, 9 months, and 12 months

Secondary Outcomes (3)

• Change in pain coping ability from baseline will be measured at each follow-up point using the Brief Pain Coping Inventory (BCPI; McCracken et al., 2005).

  Baseline and at the follow-up points 7 weeks (posttreatment), 3 months, 6 months, 9 months, and 12 months

• Change in pain self-efficacy from baseline as measured using the Facial Pain Self-Efficacy Scale (Brister, Turner, Aaron, & Mancl, 2006) at each follow-up point.

  Baseline and at the follow-up points: 7 weeks (posttreatment), 3 months, 6 months, 9 months, and 12 months

• Change in pain catastrophizing from baseline using the Pain Catastrophizing Scale (PCS; Sullivan et al., 1995) at each follow-up point

  Baseline and at the follow-up points: 7 weeks (posttreatment), 3 months, 6 months, 9 months, and 12 months

Other Outcomes (1)

• Participant rating of improvement as measured at each follow-up by the Patient Global Impression of Change scale (PGIC; Hurst & Bolton, 2004).

  Follow-up points: 7 weeks (posttreatment), 3 months, 6 months, 9 months, and 12 months

Study Arms (2)

STD+CBT

ACTIVE COMPARATOR

Standard conservative dental orofacial pain care + cognitive-behavioral coping skills treatment

Behavioral: Cognitive-Behavioral Treatment; Other: Standard Conservative Care

STD+IATP

EXPERIMENTAL

Standard conservative dental orofacial pain care + Individualized Assessment and Treatment Program; a highly individualized coping skills training procedure.

Behavioral: Individualized Assessment and Treatment Program; Other: Standard Conservative Care

Interventions

Cognitive-Behavioral Treatment BEHAVIORAL

Cognitive-behavioral coping skills training

Also known as: CBT

STD+CBT

Standard Conservative Care OTHER

Standard conservative dental care for orofacial pain

Also known as: STD

STD+CBT; STD+IATP

Individualized Assessment and Treatment Program BEHAVIORAL

Experience-sampling based cognitive behavioral coping skills assessment and training

Also known as: IATP

STD+IATP

Eligibility Criteria

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

You may qualify if:

• Age \> 18 years
• Jaw pain \> 3 mo; \> 3/10 on pain scale
• Positive Axis I diagnosis on the Diagnostic Criteria for temporomandibular disorders (DC/TMD), with or without disc displacement
• Positive on \> 1 of:
• Any myalgia diagnosis
• Any myofascial diagnosis
• Arthralgia
• TMD-related Headache

You may not qualify if:

• Lack of fluency in English
• Previous invasive surgery for TMD, not including arthrography or arthrocentesis
• Extensive anatomical destruction or deterioration of the TM joint
• Diagnosed as having pain of neuropathic or odontogenic origin
• Carrying a diagnosis of psychosis
• Taking narcotic pain medication
• Any comorbid condition necessitating use of an intraoral appliance (e.g., obstructive sleep apnea)
• Pregnancy (excluded due to prescription of NSAIDs)

Sponsors & Collaborators

• UConn Health: lead
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (1)

UConn Health

Farmington, Connecticut, 06030, United States

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Facial Pain; Chronic Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Mark D Litt, PhD

  UConn Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Neither patient nor therapists can be blinded to treatment condition. The outcomes assessors and the investigators will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 2-group randomized clinical trail

Study Record Dates

• First Submitted: May 1, 2020
• First Posted: May 6, 2020
• Study Start: February 3, 2021
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available once all data collection is completed and the primary article related to this study is published. Data will remain available until further notice.
• Access Criteria: Requestors must be credentialed investigators, with active institutional affiliation, or students in active degree programs

Locations

US (1)