Brief Treatment for Temporomandibular Pain

NCT ID: NCT00067366

Last Updated: 2017-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-10-31
• Study Completion Date: 2011-09-30

Brief Summary

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.

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.

Conditions

Temporomandibular Joint Syndrome; Myofascial Pain Dysfunction Syndrome; Orofacial Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Coping Skills Training

manualized coping skills training delivered along with conservative care

Group Type: EXPERIMENTAL

Cognitive-Behavioral treatment

Intervention Type: BEHAVIORAL

Cognitive-Behavioral skills training for chronic pain

Standard Care

Attention and life counseling added to Standard conservative care

Group Type: ACTIVE_COMPARATOR

Attention and lifestyle counseling

Intervention Type: BEHAVIORAL

Attention and lifestyle counseling added to Standard Care

Interventions

Cognitive-Behavioral treatment

Cognitive-Behavioral skills training for chronic pain

Intervention Type: BEHAVIORAL

Attention and lifestyle counseling

Attention and lifestyle counseling added to Standard Care

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UConn Health

OTHER

Sponsor Role: lead

Responsible Party

Mark Litt

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mark D Litt, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

UConn Health

Locations

University of Connecticut Health Center

Farmington, Connecticut, United States

Countries

United States

Other Identifiers

NIDCR-14607

Identifier Type: -

Identifier Source: org_study_id