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:
University of Minnesota - Clinical and Translational Science Institute
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
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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
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 June 18, 2013