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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University of Minnesota - Clinical and Translational Science Institute
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01347684
First received: April 28, 2011
Last updated: February 27, 2013
Last verified: February 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: April 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard Care
Standard care with drug intervention
Drug: Standard care using current drugs
Standard Drug therapy
Experimental: Rehabilitation
Using rehabilitation for comparing use of drug
Behavioral: Behavioral therapy, splint therapy and physical therapy
Treatment will include 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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01347684

Contacts
Contact: Eric L Schiffman, DDS 612 624 3130 schif001@umn.edu
Contact: John 0 Look, PhD 612 625 6920 lookj@umn.edu

Locations
United States, Minnesota
University of Minnesota Not yet recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Eric L Schiffman, DDS    612-624-3130    schif001@umn.edu   
Principal Investigator: Eric L Schiffman, DDS         
University of Minnesota School of Dentistry Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Eric L Schiffman, DDS, MS    612-624-3130    schif001@umn.edu   
Contact: Patricia Lenton, RDT, MS    612-624-9669    lento001@umn.edu   
Principal Investigator: Eric L Schiffman, DDS, MS         
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

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01347684     History of Changes
Other Study ID Numbers: 1103M96812
Study First Received: April 28, 2011
Last Updated: February 27, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 10, 2014