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

This study has been completed.
Information provided by (Responsible Party):
University of Colorado, Denver Identifier:
First received: November 18, 2010
Last updated: December 2, 2014
Last verified: December 2014

November 18, 2010
December 2, 2014
April 2010
July 2012   (final data collection date for primary outcome measure)
Headache frequency [ Time Frame: Measure is assessed daily for 14 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01244555 on Archive Site
Headache Disability Index [ Time Frame: Assessed at 4 time points over 14 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
Muscle Treatment for Management of Pain & Disability in Tension-type Headache
Muscle Treatment for Management of Pain & Disability in Tension-type Headache

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.

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.

Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Tension-type Headache
  • Other: ultrasound
    Twice weekly ultrasound sessions for 6 weeks
  • Other: massage
    Twice weekly massage sessions for 6 weeks
    Other Name: myofsacial trigger point therapy
  • Experimental: Massage treatment
    Intervention: Other: massage
  • Experimental: Ultrasound
    Intervention: Other: ultrasound
  • No Intervention: Wait-list
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2013
July 2012   (final data collection date for primary outcome measure)

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
18 Years to 59 Years
Contact information is only displayed when the study is recruiting subjects
United States
09-0085, 1R21AT004469-01A2
University of Colorado, Denver
University of Colorado, Denver
National Center for Complementary and Integrative Health (NCCIH)
Principal Investigator: Albert Moraska, PhD University of Colorado - Anschutz Medical Campus
University of Colorado, Denver
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP