NCT02389140

Brief Summary

The physiological response at the myofascial trigger point (MTrP) to massage is not known, yet would provide important objective evidence for a treatment effect and clarify the resolution process of a MTrP.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable

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

March 1, 2015

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 2, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 17, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

September 1, 2017

Status Verified

August 1, 2017

Enrollment Period

1.8 years

First QC Date

March 2, 2015

Last Update Submit

August 30, 2017

Conditions

Keywords

Blood flowGlucoselactic acid

Outcome Measures

Primary Outcomes (1)

  • Change in Blood Flow as measured by microdialysis

    1 hr pre intervention and 1 hr post intervention

Secondary Outcomes (3)

  • Change in Glucose as measured by microdialysis

    1 hr pre intervention and 1 hr post intervention

  • Change in Lactate as measured by microdialysis

    1 hr pre intervention and 1 hr post intervention

  • Change in Pyruvate as measured by microdialysis

    1 hr pre intervention and 1 hr post intervention

Study Arms (2)

Trigger point treatment

EXPERIMENTAL

Trigger point release

Other: Trigger point release

Ultrasound

SHAM COMPARATOR

Sham US at Trigger point

Other: Ultrasound

Interventions

Trigger point therapy

Trigger point treatment

sham ultrasound

Ultrasound

Eligibility Criteria

Age21 Years - 49 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Chronic or episodic tension-type headache
  • active MTrP in upper trapezius
  • age 21-49
  • BMI between 18.5-24.9
  • either gender
  • any race or ethnicity

You may not qualify if:

  • No or latent MTrP in the upper trapezius
  • migraine 4+/month
  • cluster headache
  • fibromyalgia
  • neurological disease (e.g. Alzheimer's disease, Parkinson's disease, muscular dystrophy, multiple sclerosis)
  • cardiovascular disease (e.g. prior heart attack or stroke)
  • diabetes
  • pregnancy
  • a bleeding disorder (Self-report of hemophilia, known lack/deficiency of clotting factors, or presently °taking anti-coagulants (e.g. warfarin, Coumadin))
  • narcotic use
  • currently receiving massage
  • prior trigger point injection or needling therapies
  • allergy to lidocaine-type anesthetics such as lidocaine and prilocaine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

  • Moraska AF, Hickner RC, Rzasa-Lynn R, Shah JP, Hebert JR, Kohrt WM. Increase in Lactate Without Change in Nutritive Blood Flow or Glucose at Active Trigger Points Following Massage: A Randomized Clinical Trial. Arch Phys Med Rehabil. 2018 Nov;99(11):2151-2159. doi: 10.1016/j.apmr.2018.06.030. Epub 2018 Aug 6.

MeSH Terms

Conditions

Tension-Type Headache

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Albert Moraska, PhD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2015

First Posted

March 17, 2015

Study Start

March 1, 2015

Primary Completion

December 1, 2016

Study Completion

January 1, 2017

Last Updated

September 1, 2017

Record last verified: 2017-08

Locations