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

University of Minnesota (UMN)

Status and phase: Withdrawn; Phase 3

Conditions: Tension-type Headache

Treatments: Drug: Standard care using current drugs; Behavioral: Behavioral therapy, splint therapy and physical therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01347684

1103M96812

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Standard care using current drugs

Active Comparator group

Description:

Standard care with drug intervention

Treatment:

Drug: Standard care using current drugs

Behavioral therapy, splint therapy and physical therapy

Experimental group

Description:

Using rehabilitation for comparing use of drug

Treatment:

Behavioral: Behavioral therapy, splint therapy and physical therapy