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Muscle Treatment for Management of Pain & Disability in Tension-type Headache

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01244555
First received: November 18, 2010
Last updated: February 7, 2013
Last verified: February 2013
History of Changes
  Purpose

The purpose of this study is to determine the effectiveness of treatments (massage therapy or ultrasound) directed at skeletal muscle for alleviating pain associated wtih tension headache.


Condition Intervention Phase
Tension-type Headache
 Other: ultrasound
Other: massage
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Muscle Treatment for Management of Pain & Disability in Tension-type Headache

Resource links provided by NLM:

MedlinePlus related topics: Headache
U.S. FDA Resources

Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Headache frequency [ Time Frame: Measure is assessed daily for 14 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Headache Disability Index [ Time Frame: Assessed at 4 time points over 14 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 72
Study Start Date: April 2010
Estimated Study Completion Date: December 2013
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Massage treatment Other: massage
Twice weekly massage sessions for 6 weeks
Other Name: myofsacial trigger point therapy
Experimental: Ultrasound Other: ultrasound
Twice weekly ultrasound sessions for 6 weeks
No Intervention: Wait-list

Detailed Description:

Chronic or episodic forms of tension-type headache affect a high percentage of the population. Pain from tension-type headache (TTH) not only impacts personal well-being, but also poses a significant socioeconomic burden in terms of workdays lost and decreased worker productivity. Although TTH is the most prevalent of the headache disorders, there is a distinct lack of research with regards to specific treatments for this ailment in comparison to all other headache classifications, such as migraine. A muscular involvement is associated with TTH and is reported in the research literature as elevation in skeletal muscle tenderness, increased presence of active myofascial trigger point's, and physical abnormalities in cervical and cranial muscles. Thus, a treatment approach that addresses the skeletal musculature could be an important component in the management of TTH. The purpose of this randomized trial is to determine the effectiveness of two muscle oriented treatments on reducing pain and disability associated with TTH: massage therapy and ultrasound.

  Eligibility

Ages Eligible for Study:   18 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 2 or more tension-type headache episodes per week
  • Headache episodes of 2 hours or longer
  • Experiencing tension-type headache for 6 months or longer

Exclusion Criteria:

  • Migraine >1/month
  • Presence of alternate forms of headache (e.g. cluster headache, medication-induced headache, headache caused by injury)
  • The diagnosis of fibromyalgia, major depression, other neurological or cardiovascular disease
  • Pregnancy
  • Prior massage or ultrasound treatment for headaches
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01244555

Locations
United States, Colorado
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
National Center for Complementary and Alternative Medicine (NCCAM)
Investigators
Principal Investigator: Albert Moraska, PhD University of Colorado Anschutz Medical Campus
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01244555     History of Changes
Other Study ID Numbers: 09-0085, 1R21AT004469-01A2
Study First Received: November 18, 2010
Last Updated: February 7, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Additional relevant MeSH terms:
Headache
Tension-Type Headache
Pain
Neurologic Manifestations
Nervous System Diseases
 Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on June 17, 2013