Assessing the Effectiveness of Two Treatment Strategies for Tension-type Headache
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Change from baseline of headache intensity of pain using pain scale of 1-10
研究概览
简要总结
The primary aim of the pilot data proposal is to compare usual care (medications) versus multi-disciplinary treatment in temporomandibular disorder (TMD) patients.
详细描述
The primary aim of the pilot data proposal is to compare usual care (medications) versus multi-disciplinary treatment in TMD patients with episodic or chronic tension-type headache (TTH) with pericranial tenderness involving the temporalis muscle at reducing the intensity of TTH pain at 1 and 6 months. The hypothesis is that a team approach will reduce the intensity of headache more than usual care in this group of patients.
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
- Single (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
- •Fifty consecutive subjects (Age 18 to 65) will be included when they fulfill the diagnostic criteria for episodic or chronic TTH with pericranial muscle tenderness3 and TMD including myofascial pain involving the temporalis muscle -
排除标准
- •Exclusion criteria, assessed by review of medical history, include:
- •systemic rheumatic disease
- •widespread pain
- •pregnancy
- •concurrent use of tricyclic antidepressants, steroids, anti-inflammatories, muscle relaxants, or narcotics
- •major psychiatric disease
- •any medical contraindications
研究组 & 干预措施
Standard care using current drugs
Standard care with drug intervention
干预措施: Standard care using current drugs (Drug)
Behavioral therapy, splint therapy and physical therapy
Using rehabilitation for comparing use of drug
干预措施: Behavioral therapy, splint therapy and physical therapy (Behavioral)
结局指标
主要结局
Change from baseline of headache intensity of pain using pain scale of 1-10
时间窗: 3 months
次要结局
未报告次要终点