Pain Management in Temporomandibular Joint Disorders
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Average Pain
研究概览
简要总结
The purpose of this study is to determine whether the combination of cognitive-behavioral treatment and nortriptyline are more effective than each treatment alone in reducing the pain and disability associated with TMD.
详细描述
This is a randomized, controlled trial evaluating pharmacological (nortriptyline vs. active placebo - benztropine) and psychological (cognitive-behavioral therapy vs. disease education) treatments for pain and disability due to temporomandibular joint disorder (TMD). Patients 18 to 65 years old meeting RDC criteria for TMD and other eligibility criteria complete a 3-week baseline monitoring phase prior to randomization. Active treatment consists of weekly visits for 8 week, then maintenance treatment for 6 months. Outcome measures include pain, physical and psychosocial function and are assessed at post-treatment, 3-months, and 6-months
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Nortriptyline Oral Capsule/CBT
Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of CBT.
干预措施: Nortriptyline Oral Capsule (Drug)
Nortriptyline Oral Capsule/CBT
Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of CBT.
干预措施: CBT (Behavioral)
Benztropine Oral Product/CBT
Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of CBT.
干预措施: Benztropine Oral Product (Drug)
Benztropine Oral Product/CBT
Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of CBT.
干预措施: CBT (Behavioral)
Nortriptyline Oral Capsule/Disease MGT
Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of TMD disease management.
干预措施: Nortriptyline Oral Capsule (Drug)
Nortriptyline Oral Capsule/Disease MGT
Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of TMD disease management.
干预措施: Disease MGT (Behavioral)
Benztropine Oral Product/Disease MGT
Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of TMD disease management.
干预措施: Benztropine Oral Product (Drug)
Benztropine Oral Product/Disease MGT
Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of TMD disease management.
干预措施: Disease MGT (Behavioral)
结局指标
主要结局
Average Pain
时间窗: baseline, post-treatment, 3 months, 6 months
0 (no pain) to 10 (pain as bad as could be) rating of average pain during the past week; higher scores indicate greater pain
Change in Pain-related Interference
时间窗: baseline, post-treatment, 3 months, 6 months
Multidimensional Pain Inventory: Pain interference subscale score; average score computed from 12 items rated on scale from 0=no interference to 6=extreme interference; higher scores indicate greater pain-related interference
次要结局
- Worst Pain(baseline, post-treatment, 3 months, 6 months)
- Mental Health as Assessed by the Short Form 36 Healthy Survey(baseline, post-treatment, 3 months, 6 months)