Brief Treatment for Temporomandibular Pain

Not Applicable

Completed

• Conditions: Orofacial Pain; Myofascial Pain Dysfunction Syndrome; Temporomandibular Joint Syndrome
• Interventions: Behavioral: Cognitive-Behavioral treatment; Behavioral: Attention and lifestyle counseling

• Registration Number: NCT00067366
• Lead Sponsor: UConn Health

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.

Study Timeline

• Study First Submitted: 2003-08-15
• Study First Submitted QC: 2003-08-18
• Study First Posted: 2003-08-19
• Study Start: 2003-10
• Primary Completion: 2008-10
• Study Completion: 2011-09
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-27
• Last Update Posted: 2017-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Coping Skills Training	Cognitive-Behavioral treatment	manualized coping skills training delivered along with conservative care
Standard Care	Attention and lifestyle counseling	Attention and life counseling added to Standard conservative care

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Connecticut Health Center; 🇺🇸 Farmington, Connecticut, United States