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

NCT ID: NCT01244555

Last Updated: 2015-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2013-12-31

Brief Summary

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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

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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.

Conditions

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Tension-type Headache

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Massage treatment

Group Type EXPERIMENTAL

massage

Intervention Type OTHER

Twice weekly massage sessions for 6 weeks

Ultrasound

Group Type EXPERIMENTAL

ultrasound

Intervention Type OTHER

Twice weekly ultrasound sessions for 6 weeks

Wait-list

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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ultrasound

Twice weekly ultrasound sessions for 6 weeks

Intervention Type OTHER

massage

Twice weekly massage sessions for 6 weeks

Intervention Type OTHER

Other Intervention Names

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myofsacial trigger point therapy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Albert Moraska, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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1R21AT004469-01A2

Identifier Type: NIH

Identifier Source: secondary_id

View Link

09-0085

Identifier Type: -

Identifier Source: org_study_id