Muscle Treatment for Management of Pain & Disability in Tension-type Headache
Primary Purpose
Tension-type Headache
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ultrasound
massage
Sponsored by
About this trial
This is an interventional treatment trial for Tension-type Headache
Eligibility Criteria
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
Sites / Locations
- University of Colorado Anschutz Medical Campus
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Massage treatment
Ultrasound
Wait-list
Arm Description
Outcomes
Primary Outcome Measures
Headache frequency
Secondary Outcome Measures
Headache Disability Index
Full Information
NCT ID
NCT01244555
First Posted
November 18, 2010
Last Updated
November 30, 2015
Sponsor
University of Colorado, Denver
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT01244555
Brief Title
Muscle Treatment for Management of Pain & Disability in Tension-type Headache
Official Title
Muscle Treatment for Management of Pain & Disability in Tension-type Headache
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tension-type Headache
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
69 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Massage treatment
Arm Type
Experimental
Arm Title
Ultrasound
Arm Type
Experimental
Arm Title
Wait-list
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
ultrasound
Intervention Description
Twice weekly ultrasound sessions for 6 weeks
Intervention Type
Other
Intervention Name(s)
massage
Other Intervention Name(s)
myofsacial trigger point therapy
Intervention Description
Twice weekly massage sessions for 6 weeks
Primary Outcome Measure Information:
Title
Headache frequency
Time Frame
Measure is assessed daily for 14 weeks
Secondary Outcome Measure Information:
Title
Headache Disability Index
Time Frame
Assessed at 4 time points over 14 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Albert Moraska, PhD
Organizational Affiliation
University of Colorado - Anschutz Medical Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Muscle Treatment for Management of Pain & Disability in Tension-type Headache
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