Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00067366
Status:
COMPLETED
Last Update Posted:
2017-08-01
First Post:
2003-08-15
Brief Title:
Brief Treatment for Temporomandibular Pain
Sponsor:
UConn Health
Organization:
UConn Health
Study Overview
Official Title:
Brief Focused Treatment for TMD Mechanisms of Action
Status:
COMPLETED
Status Verified Date:
2017-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 N106 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 STDCBT 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 STDCBT 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None