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

Tracking Information

First Received Date ^ICMJE

November 18, 2010

Last Updated Date

February 7, 2013

Start Date ^ICMJE

April 2010

Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01244555 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

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 ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Tension-type Headache

Intervention ^ICMJE

Other: ultrasound
Twice weekly ultrasound sessions for 6 weeks
Other: massage
Twice weekly massage sessions for 6 weeks

Other Name: myofsacial trigger point therapy

Study Arm (s)

Experimental: Massage treatment
Intervention: Other: massage
Experimental: Ultrasound
Intervention: Other: ultrasound
No Intervention: Wait-list

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2013

Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 59 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01244555

Other Study ID Numbers ^ICMJE

09-0085, 1R21AT004469-01A2

Has Data Monitoring Committee

Yes

Responsible Party

University of Colorado, Denver

Study Sponsor ^ICMJE

University of Colorado, Denver

Collaborators ^ICMJE

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators ^ICMJE

Principal Investigator:

Albert Moraska, PhD

University of Colorado Anschutz Medical Campus

Information Provided By

University of Colorado, Denver

Verification Date

February 2013

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

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