Skip to main content
OpenTrials
Completed

NCT Number: NCT01244555

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ultrasound

Other

Twice weekly ultrasound sessions for 6 weeks

Massage

Other

Twice weekly massage sessions for 6 weeks

Other names: myofsacial trigger point therapy

Primary outcomes

  1. Headache frequency

    Time frame: Measure is assessed daily for 14 weeks

Secondary outcomes

  1. Headache Disability Index

    Time frame: Assessed at 4 time points over 14 weeks

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Nov 19, 2010
Registry last updated
Dec 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.