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

This study has been withdrawn prior to enrollment.
(PI left University of Minnesota)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01347684
First Posted: May 4, 2011
Last Update Posted: December 7, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
  Purpose
The primary aim of the pilot data proposal is to compare usual care (medications) versus multi-disciplinary treatment in temporomandibular disorder (TMD) patients.

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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

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

Enrollment: 0
Study Start Date: April 2012
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

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 Submitted: April 28, 2011
First Posted: May 4, 2011
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


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