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

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

Status
Withdrawn
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01347684
Enrollment
0
Registered
2011-05-04
Start date
2012-04-30
Completion date
2015-07-31
Last updated
2016-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tension-type Headache

Keywords

headache, elavil, splints, physical therapy, behavioral therapy

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.

Interventions

BEHAVIORALBehavioral therapy, splint therapy and physical therapy

Includes patient education, use of a mouth guard, jaw muscle exercises and brief cognitive-behavioral intervention.

DRUGStandard care using current drugs

Standard Drug therapy

Sponsors

University of Minnesota
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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 -

Design outcomes

Primary

MeasureTime frame
Change from baseline of headache intensity of pain using pain scale of 1-103 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026