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

NCT ID: NCT01347684

Last Updated: 2016-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2015-07-31

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.

Conditions

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Tension-type Headache

Keywords

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headache elavil splints physical therapy behavioral therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Standard care using current drugs

Standard care with drug intervention

Group Type ACTIVE_COMPARATOR

Standard care using current drugs

Intervention Type DRUG

Standard Drug therapy

Behavioral therapy, splint therapy and physical therapy

Using rehabilitation for comparing use of drug

Group Type EXPERIMENTAL

Behavioral therapy, splint therapy and physical therapy

Intervention Type BEHAVIORAL

Includes patient education, use of a mouth guard, jaw muscle exercises and brief cognitive-behavioral intervention.

Interventions

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Behavioral therapy, splint therapy and physical therapy

Includes patient education, use of a mouth guard, jaw muscle exercises and brief cognitive-behavioral intervention.

Intervention Type BEHAVIORAL

Standard care using current drugs

Standard Drug therapy

Intervention Type DRUG

Other Intervention Names

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Medications: Amitryptoline or has unacceptable side-effects, then other tricyclics and/or muscle relaxants are allowed.1

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

* systemic rheumatic disease
* widespread pain
* pregnancy
* concurrent use of tricyclic antidepressants, steroids, anti-inflammatories, muscle relaxants, or narcotics
* major psychiatric disease
* any medical contraindications
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eric L Schiffman, DDS

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

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University of Minnesota School of Dentistry

Minneapolis, Minnesota, United States

Site Status

University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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1103M96812

Identifier Type: -

Identifier Source: org_study_id