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

Study Overview
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Brief Summary
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The primary aim of the pilot data proposal is to compare usual care (medications) versus multi-disciplinary treatment in temporomandibular disorder (TMD) patients.

Detailed Description
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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.

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

Conditions
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Tension-type Headache

Intervention / Treatment
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* Behavioral: Behavioral therapy, splint therapy and physical therapy
* Drug: Standard care using current drugs


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 - Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard care using current drugs<br>Standard care with drug intervention | Drug: Standard care using current drugs<br>* Standard Drug therapy<br>|
| Experimental: Behavioral therapy, splint therapy and physical therapy<br>Using rehabilitation for comparing use of drug | Behavioral: Behavioral therapy, splint therapy and physical therapy<br>* Includes patient education, use of a mouth guard, jaw muscle exercises and brief cognitive-behavioral intervention.<br>* Other names: Medications: Amitryptoline or has unacceptable side-effects, then other tricyclics and/or muscle relaxants are allowed.1;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of headache intensity of pain using pain scale of 1-10 |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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headache, elavil, splints, physical therapy, behavioral therapy