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

This study has been completed.
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: May 19, 2016
Last verified: May 2016

April 28, 2011
May 19, 2016
April 2012
July 2015   (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
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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
    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
  • Drug: Standard care using current drugs
    Standard Drug therapy
  • Active Comparator: Standard care using current drugs
    Standard care with drug intervention
    Intervention: Drug: Standard care using current drugs
  • Experimental: Behavioral therapy, splint therapy and physical therapy
    Using rehabilitation for comparing use of drug
    Intervention: Behavioral: Behavioral therapy, splint therapy and physical therapy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
9
July 2015
July 2015   (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   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01347684
1103M96812
No
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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
May 2016

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