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

Tension-type Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01244555
• Other study ID #: 09-0085
• Secondary ID: 1R21AT004469-01A
• Status: Completed
• Phase: Phase 2
• First received: November 18, 2010
• Last updated: November 30, 2015
• Start date: April 2010
• Est. completion date: December 2013

Study information

• Verified date: November 2015
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: December 2013
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 59 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Headache
• Tension-Type Headache

Intervention

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

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Headache frequency		Measure is assessed daily for 14 weeks	No
Secondary	Headache Disability Index		Assessed at 4 time points over 14 weeks	No