Brief Treatment for Temporomandibular Pain

Orofacial Pain Clinical Trial

Official title:

Brief Focused Treatment for TMD: Mechanisms of Action

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00067366
• Other study ID #: NIDCR-14607
• Status: Completed
• Phase: N/A
• First received: August 15, 2003
• Last updated: July 27, 2017
• Start date: October 2003
• Est. completion date: September 2011

Study information

• Verified date: July 2017
• Source: UConn Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: September 2011
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Facial Pain
• Fibromyalgia
• Myofascial Pain Dysfunction Syndrome
• Myofascial Pain Syndromes
• Orofacial Pain
• Syndrome
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome
• Temporomandibular Joint Syndrome

Intervention

Behavioral:
• Cognitive-Behavioral treatment
Cognitive-Behavioral skills training for chronic pain
• Attention and lifestyle counseling
Attention and lifestyle counseling added to Standard Care

Locations

Country	Name	City	State
United States	University of Connecticut Health Center	Farmington	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
UConn Health

Country where clinical trial is conducted

United States, 

Outcome

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