Back to resultsAssessing the Effectiveness of Two Treatment Strategies for Tension-type Headache
Primary Purpose
Tension-type Headache
Status
Withdrawn
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Behavioral therapy, splint therapy and physical therapy
Standard care using current drugs
Sponsored by
About this trial
This is an interventional treatment trial for Tension-type Headache focused on measuring headache, elavil, splints, physical therapy, behavioral therapy
Eligibility 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
Sites / Locations
- University of Minnesota School of Dentistry
- University of Minnesota
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard care using current drugs
Behavioral therapy, splint therapy and physical therapy
Arm Description
Standard care with drug intervention
Using rehabilitation for comparing use of drug
Outcomes
Primary Outcome Measures
Change from baseline of headache intensity of pain using pain scale of 1-10
Secondary Outcome Measures
Full Information
NCT ID
NCT01347684
First Posted
April 28, 2011
Last Updated
December 6, 2016
Sponsor
University of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT01347684
Brief Title
Assessing the Effectiveness of Two Treatment Strategies for Tension-type Headache
Official Title
Assessing the Effectiveness of Two Treatment Strategies for Tension-type Headache
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Withdrawn
Why Stopped
PI left University of Minnesota
Study Start Date
April 2012 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary aim of the pilot data proposal is to compare usual care (medications) versus multi-disciplinary treatment in temporomandibular disorder (TMD) patients.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tension-type Headache
Keywords
headache, elavil, splints, physical therapy, behavioral therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard care using current drugs
Arm Type
Active Comparator
Arm Description
Standard care with drug intervention
Arm Title
Behavioral therapy, splint therapy and physical therapy
Arm Type
Experimental
Arm Description
Using rehabilitation for comparing use of drug
Intervention Type
Behavioral
Intervention Name(s)
Behavioral therapy, splint therapy and physical therapy
Other Intervention Name(s)
Medications: Amitryptoline or has unacceptable side-effects, then other tricyclics and/or muscle relaxants are allowed.1
Intervention Description
Includes patient education, use of a mouth guard, jaw muscle exercises and brief cognitive-behavioral intervention.
Intervention Type
Drug
Intervention Name(s)
Standard care using current drugs
Intervention Description
Standard Drug therapy
Primary Outcome Measure Information:
Title
Change from baseline of headache intensity of pain using pain scale of 1-10
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric L Schiffman, DDS
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota School of Dentistry
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
12. IPD Sharing Statement
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Assessing the Effectiveness of Two Treatment Strategies for Tension-type Headache
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