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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
TMD3c Trial 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.Check my eligibility
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.See study design
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.
TMD3c Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am older than 18 years.
Select...
I have had jaw pain for more than 3 months, rating over 3 out of 10.
Select...
I have been diagnosed with a jaw joint disorder.
Select...
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:Select...
You do not speak English fluently.
TMD3c Trial Timeline
Screening ~ 3 days2 visits
Treatment ~ 6 weeks0 visits
Follow Up ~ 12 months1 visit
Screening ~ 3 days
Treatment ~ 6 weeks
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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 outcome measures
Participant rating of improvement as measured at each follow-up by the Patient Global Impression of Change scale (PGIC; Hurst & Bolton, 2004).
TMD3c 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
Find a Location
Who is running the clinical trial?
National Institute of Dental and Craniofacial Research (NIDCR)NIH
300 Previous Clinical Trials
848,184 Total Patients Enrolled
UConn HealthLead Sponsor
211 Previous Clinical Trials
60,461 Total Patients Enrolled
Mark D Litt, PhDPrincipal InvestigatorUConn Health
2 Previous Clinical Trials
408 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with nerve or tooth-related pain.I have been diagnosed with a muscle or fascia condition.I have been diagnosed with muscle pain, joint pain, or TMJ-related headaches.You have been diagnosed with a mental illness called psychosis.I use a device in my mouth for a health condition like sleep apnea.My jaw joint is severely damaged.You do not speak English fluently.I am currently receiving treatment for depression.I have had surgery for my jaw joint disorder.I have been diagnosed with a jaw joint disorder.I am older than 18 years.I have had jaw pain for more than 3 months, rating over 3 out of 10.I am older than 18 years.I am currently taking prescription pain medication.I have been diagnosed with muscle pain.I have been diagnosed with a jaw joint disorder.I experience joint pain.I have had jaw pain for more than 3 months, rating over 3 out of 10.
Research Study Groups:
This trial has the following groups:- Group 1: STD+CBT
- Group 2: STD+IATP
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 6 Weeks
- Follow Ups: You may be asked to continue sharing information regarding the trial for 12 Months after you stop receiving the treatment.
Temporomandibular Joint Disorder Patient Testimony for trial: Trial Name: NCT04376333 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the maximum number of participants who can enroll in this experiment?
"Affirmative, the information hosted on clinicaltrials.gov states that this study is actively recruiting participants. First posted in March 2021 and most recently updated in July 2022, it requires 160 patients from one location to participate."
Answered by AI
Who else is applying?
What state do they live in?
Florida
New York
What site did they apply to?
UConn Health
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
3+
Why did patients apply to this trial?
I have done numerous procedures and have had no relief. I have not yet been given a treatment plan. My orthodontist was booked a year out which really made me sad. TMJ has completely altered my mental health and the way I am anle.
PatientReceived no prior treatments
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