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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00067366
Other study ID # NIDCR-14607
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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