Assessing the Effectiveness of Two Treatment Strategies for Tension-type Headache
Trial Snapshot
- Phase
- Phase 3
- Status
- Withdrawn
- Sponsor
- University of Minnesota
- Locations
- 2
- Primary Endpoint
- Change from baseline of headache intensity of pain using pain scale of 1-10
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Standard care using current drugs
Standard care with drug intervention
Intervention: Standard care using current drugs (Drug)
Behavioral therapy, splint therapy and physical therapy
Using rehabilitation for comparing use of drug
Intervention: Behavioral therapy, splint therapy and physical therapy (Behavioral)
Outcomes
Primary Outcomes
Change from baseline of headache intensity of pain using pain scale of 1-10
Time Frame: 3 months
Secondary Outcomes
No secondary outcomes reported