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

Tension-type Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01347684
• Other study ID #: 1103M96812
• Status: Withdrawn
• Phase: Phase 3
• First received: April 28, 2011
• Last updated: December 6, 2016
• Start date: April 2012
• Est. completion date: July 2015

Study information

• Verified date: December 2016
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Headache
• Tension-Type Headache

Intervention

Behavioral:
• Behavioral therapy, splint therapy and physical therapy
Includes patient education, use of a mouth guard, jaw muscle exercises and brief cognitive-behavioral intervention.

Drug:
• Standard care using current drugs
Standard Drug therapy

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota
United States	University of Minnesota School of Dentistry	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline of headache intensity of pain using pain scale of 1-10		3 months	No