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

November 30, 2015 updated by: University of Colorado, Denver
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

69

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Anschutz Medical Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 59 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ultrasound
Other: ultrasound
Twice weekly ultrasound sessions for 6 weeks
No Intervention: Wait-list
Experimental: Massage treatment
Other: massage
Twice weekly massage sessions for 6 weeks
Other Names:
  • myofsacial trigger point therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Headache frequency
Time Frame: Measure is assessed daily for 14 weeks
Measure is assessed daily for 14 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Headache Disability Index
Time Frame: Assessed at 4 time points over 14 weeks
Assessed at 4 time points over 14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

Investigators

  • Principal Investigator: Albert Moraska, PhD, University of Colorado - Anschutz Medical Campus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

November 18, 2010

First Submitted That Met QC Criteria

November 18, 2010

First Posted (Estimate)

November 19, 2010

Study Record Updates

Last Update Posted (Estimate)

December 2, 2015

Last Update Submitted That Met QC Criteria

November 30, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-0085
  • 1R21AT004469-01A2 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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