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

NCT01347684 | Withdrawn Phase 3

• 1 other identifier: 1103M96812
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Tension-type Headache

Keywords

headache; elavil; splints; physical therapy; behavioral therapy

Outcome Measures

Primary Outcomes (1)

• Change from baseline of headache intensity of pain using pain scale of 1-10

  3 months

Study Arms (2)

Standard care using current drugs

ACTIVE COMPARATOR

Standard care with drug intervention

Drug: Standard care using current drugs

Behavioral therapy, splint therapy and physical therapy

EXPERIMENTAL

Using rehabilitation for comparing use of drug

Behavioral: Behavioral therapy, splint therapy and physical therapy

Interventions

Behavioral therapy, splint therapy and physical therapy BEHAVIORAL

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

Also known as: Medications: Amitryptoline or has unacceptable side-effects, then other tricyclics and/or muscle relaxants are allowed.1

Behavioral therapy, splint therapy and physical therapy

Standard care using current drugs DRUG

Standard Drug therapy

Standard care using current drugs

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 -

You may not qualify if:

• systemic rheumatic disease
• widespread pain
• pregnancy
• concurrent use of tricyclic antidepressants, steroids, anti-inflammatories, muscle relaxants, or narcotics
• major psychiatric disease
• any medical contraindications

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (2)

University of Minnesota School of Dentistry

Minneapolis, Minnesota, 55455, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Tension-Type Headache; Headache

Interventions

Behavior Therapy; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Therapeutics; Rehabilitation

Study Officials

• Eric L Schiffman, DDS

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2011
• First Posted: May 4, 2011
• Study Start: April 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: December 7, 2016

Record last verified: 2016-12

Locations

US (2)