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

This study is currently recruiting participants.
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

April 28, 2011
February 27, 2013
April 2012
May 2014   (final data collection date for primary outcome measure)
Change from baseline of headache intensity of pain using pain scale of 1-10 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01347684 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Assessing the Effectiveness of Two Treatment Strategies for Tension-type Headache
Assessing the Effectiveness of Two Treatment Strategies for Tension-type Headache

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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Tension-type Headache
  • 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
  • Drug: Standard care using current drugs
    Standard Drug therapy
  • Active Comparator: Standard Care
    Standard care with drug intervention
    Intervention: Drug: Standard care using current drugs
  • Experimental: Rehabilitation
    Using rehabilitation for comparing use of drug
    Intervention: Behavioral: Behavioral therapy, splint therapy and physical therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
May 2014
May 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact: Eric L Schiffman, DDS 612 624 3130 schif001@umn.edu
Contact: John 0 Look, PhD 612 625 6920 lookj@umn.edu
United States
 
NCT01347684
1103M96812
No
University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
Not Provided
Principal Investigator: Eric L Schiffman, DDS University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP