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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:
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

November 18, 2010
February 7, 2013
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 ClinicalTrials.gov 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.

Interventional
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
72
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
Both
18 Years to 59 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01244555
09-0085, 1R21AT004469-01A2
Yes
University of Colorado, Denver
University of Colorado, Denver
National Center for Complementary and Alternative Medicine (NCCAM)
Principal Investigator: Albert Moraska, PhD University of Colorado Anschutz Medical Campus
University of Colorado, Denver
February 2013

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