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Individualized Treatment for TMJ Dysfunction (TMD3c Trial)

N/A

Recruiting

Led By Mark D Litt, PhD

Research Sponsored by UConn Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age > 18 years

Jaw pain > 3 mo; > 3/10 on pain scale

Must not have

Lack of fluency in English

Timeline

Screening 3 days

Treatment 6 weeks

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new, individualized treatment for TMD that could be more effective than other psychosocial treatments. The goal is to also discover the mechanisms by which psychosocial treatments work in chronic pain.

Who is the study for?

This trial is for adults over 18 living in the Greater Hartford, CT area with facial pain or TMJ disorders. Participants must have a confirmed diagnosis of TMD and experience jaw pain for more than three months. It's not open to those on narcotic pain meds, with previous TMD surgery, severe TM joint damage, non-English speakers, neuropathic/odontogenic pain origins, certain comorbid conditions or current depression treatment.

What is being tested?

The study compares two treatments for TMD: an individualized assessment and treatment program (IATP) added to standard care versus standard care plus conventional cognitive-behavioral therapy (CBT). The goal is to see if IATP leads to better outcomes in reducing pain and improving coping skills compared to CBT.

What are the potential side effects?

Since the interventions involve psychosocial treatments like assessments and behavioral therapy rather than medication, side effects are minimal but may include discomfort from discussing personal issues or stress from time commitment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am older than 18 years.

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I have had jaw pain for more than 3 months, rating over 3 out of 10.

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I have been diagnosed with a jaw joint disorder.

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I have been diagnosed with muscle pain, joint pain, or TMJ-related headaches.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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You do not speak English fluently.

Timeline

Screening ~ 3 days2 visits

Treatment ~ 6 weeks0 visits

Follow Up ~ 12 months1 visit

Screening ~ 3 days

Treatment ~ 6 weeks

Follow Up ~12 months

This trial's timeline: 3 days for screening, 6 weeks for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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).

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

Secondary study objectives

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

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).

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.

Other study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: STD+IATPExperimental Treatment2 Interventions

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

Group II: STD+CBTActive Control2 Interventions

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

0 / 5Eligibility criteria met