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

Phase 3

Withdrawn

• Conditions: Tension-type Headache
• Interventions: Drug: Standard care using current drugs; Behavioral: Behavioral therapy, splint therapy and physical therapy

• Registration Number: NCT01347684
• Lead Sponsor: University of Minnesota

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 Timeline

• Study First Submitted: 2011-04-28
• Study First Submitted QC: 2011-05-03
• Study First Posted: 2011-05-04
• Study Start: 2012-04
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-06
• Last Update Posted: 2016-12-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard care using current drugs	Standard care using current drugs	Standard care with drug intervention
Behavioral therapy, splint therapy and physical therapy	Behavioral therapy, splint therapy and physical therapy	Using rehabilitation for comparing use of drug

Primary Outcome Measures

Name	Time	Method
Change from baseline of headache intensity of pain using pain scale of 1-10	3 months

Trial Locations

Locations (2)

University of Minnesota School of Dentistry; 🇺🇸 Minneapolis, Minnesota, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States