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

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ClinicalTrials.gov Identifier: NCT01347684
Recruitment Status : Withdrawn (PI left University of Minnesota)
First Posted : May 4, 2011
Last Update Posted : December 7, 2016
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Tension-type Headache Behavioral: Behavioral therapy, splint therapy and physical therapy Drug: Standard care using current drugs Phase 3

Detailed Description:
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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assessing the Effectiveness of Two Treatment Strategies for Tension-type Headache
Study Start Date : April 2012
Primary Completion Date : July 2015
Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Change from baseline of headache intensity of pain using pain scale of 1-10 [ Time Frame: 3 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01347684


Locations
United States, Minnesota
University of Minnesota School of Dentistry
Minneapolis, Minnesota, United States, 55455
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Eric L Schiffman, DDS University of Minnesota - Clinical and Translational Science Institute
More Information

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01347684     History of Changes
Other Study ID Numbers: 1103M96812
First Posted: May 4, 2011    Key Record Dates
Last Update Posted: December 7, 2016
Last Verified: December 2016

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
headache
elavil
splints
physical therapy
behavioral therapy

Additional relevant MeSH terms:
Headache
Tension-Type Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases