NCT01244555

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2010

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 19, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

December 2, 2015

Status Verified

November 1, 2015

Enrollment Period

2.3 years

First QC Date

November 18, 2010

Last Update Submit

November 30, 2015

Conditions

Tension-type Headache

Outcome Measures

Primary Outcomes (1)

  • Headache frequency

    Measure is assessed daily for 14 weeks

Secondary Outcomes (1)

  • Headache Disability Index

    Assessed at 4 time points over 14 weeks

Study Arms (3)

Massage treatment

EXPERIMENTAL
Other: massage

Ultrasound

EXPERIMENTAL
Other: ultrasound

Wait-list

NO INTERVENTION

Interventions

ultrasoundOTHER

Twice weekly ultrasound sessions for 6 weeks

Ultrasound
massageOTHER

Twice weekly massage sessions for 6 weeks

Also known as: myofsacial trigger point therapy
Massage treatment

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • or more tension-type headache episodes per week
  • Headache episodes of 2 hours or longer
  • Experiencing tension-type headache for 6 months or longer

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Tension-Type Headache

Interventions

High-Energy Shock WavesMassage

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical PhenomenaTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Albert Moraska, PhD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2010

First Posted

November 19, 2010

Study Start

April 1, 2010

Primary Completion

July 1, 2012

Study Completion

December 1, 2013

Last Updated

December 2, 2015

Record last verified: 2015-11

Locations

US(1)