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临床试验/NCT00067366
NCT00067366已完成不适用

Brief Focused Treatment for TMD: Mechanisms of Action

UConn Health2 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2003年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
116
试验地点
2
主要终点
Pain

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Coping Skills Training

Experimental

manualized coping skills training delivered along with conservative care

干预措施: Cognitive-Behavioral treatment (Behavioral)

Standard Care

Active Comparator

Attention and life counseling added to Standard conservative care

干预措施: Attention and lifestyle counseling (Behavioral)

结局指标

主要结局

Pain

时间窗: Every 3 months out to 12 months

Multidimensional pain ratings collected in person every 3 months

Pain-related interference with functioning

时间窗: every 3 months out to 12 months

Multidimensional function ratings collected in person every 3 months

Depressive symptoms

时间窗: Every 3 months out to 12 months

CES-D depressive symtpoms scale administered in perosn every 3 months.

次要结局

未报告次要终点

研究者

发起方
UConn Health
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mark Litt

Professor

UConn Health

研究点 (2)

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