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

December 6, 2016 updated by: University of Minnesota
The primary aim of the pilot data proposal is to compare usual care (medications) versus multi-disciplinary treatment in temporomandibular disorder (TMD) patients.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota School of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Investigators

  • Principal Investigator: Eric L Schiffman, DDS, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

April 28, 2011

First Submitted That Met QC Criteria

May 3, 2011

First Posted (Estimate)

May 4, 2011

Study Record Updates

Last Update Posted (Estimate)

December 7, 2016

Last Update Submitted That Met QC Criteria

December 6, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1103M96812

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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