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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01244555
Enrollment
69
Registered
2010-11-19
Start date
2010-04-30
Completion date
2013-12-31
Last updated
2015-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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.

Interventions

OTHERultrasound

Twice weekly ultrasound sessions for 6 weeks

OTHERmassage

Twice weekly massage sessions for 6 weeks

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Headache frequencyMeasure is assessed daily for 14 weeks

Secondary

MeasureTime frame
Headache Disability IndexAssessed at 4 time points over 14 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026