Brief Treatment for Temporomandibular Pain

Brief Focused Treatment for TMD: Mechanisms of Action

Temporomandibular Disorder (TMD) is a widespread chronic pain condition. Successful psychosocial treatments for TMD have been developed, but the mechanisms by which these treatments achieve their effects are not well known. The goal of this project is to evaluate the possible mechanisms responsible for treatment gains in TMD treatment.

Study Overview

• Status: Completed
• Conditions: Orofacial Pain; Myofascial Pain Dysfunction Syndrome; Temporomandibular Joint Syndrome
• Intervention / Treatment: Behavioral: Cognitive-Behavioral treatment; Behavioral: Attention and lifestyle counseling

Detailed Description

TMD is a widespread chronic pain condition. Successful psychosocial treatments for TMD have been developed, but the mechanisms by which these treatments achieve their effects are not well known. The goal of this project is to evaluate the possible mechanisms responsible for treatment gains in TMD treatment. Men and women (N=106) with complaints of chronic facial pain for at least 3 months' duration will be recruited from the University Dental Clinics and from the community via advertisements and randomly assigned to either a Standard Conservative Treatment (STD) employing an intraoral splint plus anti-inflammatory agents, or to a Standard Treatment + Cognitive-Behavioral Treatment Program (STD+CBT), that will include standard treatment but also focus on changing self-efficacy and decreasing catastrophization. Both treatments will entail 6 clinic visits. Dispositional and situational variables derived from a comprehensive model of pain coping will be measured before and after treatment. The situational variables, including coping responses, mood states, situational appraisals and self-efficacy, will be measured in an experience sampling paradigm four times daily using a hand-held computer. This will be done to minimize retrospective biases that may have hampered earlier studies of treatment process. Dependent variables will be self-report measures of distress, pain, and interference with activities, as well as blood plasma levels of cortisol and selected cytokines, measured at the end of the 6-week treatment period, and at follow-up points thereafter up to a 12-month follow-up. It is expected that the STD+CBT treatment will result in measurable changes in constructs such as self-efficacy and catastrophization, and that these changes will be related to improved outcomes compared to the STD controls. It is also expected that outcome differences between groups will be associated with changes in inflammatory mediators (cytokine levels). Finally, it is suggested that changes in situational treatment process variables will be associated with changes in cytokine levels. The results may indicate the true active mechanisms of successful TMD treatment. If these mechanisms can be successfully identified it would have important implications for the development of more effective treatment programs.

• Study Type: Interventional
• Enrollment (Actual): 116
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Farmington, Connecticut, United States, 06030
      • University of Connecticut Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Complaining of chronic TM-related pain for at least 3 months
• Positive Axis I diagnosis on the Research Diagnostic Criteria (RDC) for temporomandibular disorders (positive on at least one Group), and may have no contraindications to TMD treatment
• Fluency in English

Exclusion Criteria:

• No previous surgery for treatment of TMD pain
• No history of rheumatoid disease
• No extensive anatomical destruction or deterioration of the TM joint
• Not diagnosed as having pain of neuropathic or odontogenic origin
• Not carrying a diagnosis of psychosis
• No current treatment for depression
• Not taking narcotic pain medication
• Not pregnant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Coping Skills Training; manualized coping skills training delivered along with conservative care	Behavioral: Cognitive-Behavioral treatment; Cognitive-Behavioral skills training for chronic pain
Active Comparator: Standard Care; Attention and life counseling added to Standard conservative care	Behavioral: Attention and lifestyle counseling; Attention and lifestyle counseling added to Standard Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain	Multidimensional pain ratings collected in person every 3 months	Every 3 months out to 12 months
Pain-related interference with functioning	Multidimensional function ratings collected in person every 3 months	every 3 months out to 12 months
Depressive symptoms	CES-D depressive symtpoms scale administered in perosn every 3 months.	Every 3 months out to 12 months

Collaborators and Investigators

• Sponsor: UConn Health
• Investigators: Principal Investigator: Mark D Litt, Ph.D., UConn Health

Study record dates

Study Major Dates

• Study Start: October 1, 2003
• Primary Completion (Actual): October 1, 2008
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: August 15, 2003
• First Submitted That Met QC Criteria: August 18, 2003
• First Posted (Estimate): August 19, 2003

Study Record Updates

• Last Update Posted (Actual): August 1, 2017
• Last Update Submitted That Met QC Criteria: July 27, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Pain; Neurologic Manifestations; Disease; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Stomatognathic Diseases; Jaw Diseases; Craniomandibular Disorders; Mandibular Diseases; Syndrome; Fibromyalgia; Myofascial Pain Syndromes; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Facial Pain
• Other Study ID Numbers: NIDCR-14607