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临床试验/NCT01347684
NCT01347684撤回3 期

Assessing the Effectiveness of Two Treatment Strategies for Tension-type Headache

University of Minnesota2 个研究点 分布在 1 个国家开始时间: 2012年4月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

Standard care with drug intervention

干预措施: Standard care using current drugs (Drug)

Behavioral therapy, splint therapy and physical therapy

Experimental

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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