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

Phase 2

Completed

• Conditions: Tension-type Headache
• Interventions: Other: massage; Other: ultrasound

• Registration Number: NCT01244555
• Lead Sponsor: University of Colorado, Denver

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 Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-11-18
• Study First Submitted QC: 2010-11-18
• Study First Posted: 2010-11-19
• Primary Completion: 2012-07
• Study Completion: 2013-12
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-30
• Last Update Posted: 2015-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Massage treatment	massage	-
Ultrasound	ultrasound	-

Primary Outcome Measures

Name	Time	Method
Headache frequency	Measure is assessed daily for 14 weeks

Secondary Outcome Measures

Name	Time	Method
Headache Disability Index	Assessed at 4 time points over 14 weeks

Trial Locations

Locations (1)

University of Colorado Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States