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Brief Treatment for Temporomandibular Pain

Brief Focused Treatment for TMD: Mechanisms of Action

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00067366
Enrollment
116
Registered
2003-08-19
Start date
2003-10-31
Completion date
2011-09-30
Last updated
2017-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Temporomandibular Joint Syndrome, Myofascial Pain Dysfunction Syndrome, Orofacial Pain

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.

Interventions

Cognitive-Behavioral skills training for chronic pain

BEHAVIORALAttention and lifestyle counseling

Attention and lifestyle counseling added to Standard Care

Sponsors

UConn Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
PainEvery 3 months out to 12 monthsMultidimensional pain ratings collected in person every 3 months
Pain-related interference with functioningevery 3 months out to 12 monthsMultidimensional function ratings collected in person every 3 months
Depressive symptomsEvery 3 months out to 12 monthsCES-D depressive symtpoms scale administered in perosn every 3 months.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026