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

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ClinicalTrials.gov Identifier: NCT01244555
Recruitment Status : Completed
First Posted : November 19, 2010
Last Update Posted : December 2, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Tension-type Headache Other: ultrasound Other: massage Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Muscle Treatment for Management of Pain & Disability in Tension-type Headache
Study Start Date : April 2010
Primary Completion Date : July 2012
Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. Headache frequency [ Time Frame: Measure is assessed daily for 14 weeks ]

Secondary Outcome Measures :
  1. Headache Disability Index [ Time Frame: Assessed at 4 time points over 14 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01244555

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 Integrative Health (NCCIH)
Principal Investigator: Albert Moraska, PhD University of Colorado - Anschutz Medical Campus
More Information

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01244555     History of Changes
Other Study ID Numbers: 09-0085
1R21AT004469-01A2 ( U.S. NIH Grant/Contract )
First Posted: November 19, 2010    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: November 2015

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