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Blood Flow Within Active Myofascial Trigger Points Following Massage

Primary Purpose

Myofascial Pain, Tension-type Headache

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Trigger point release
Ultrasound
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Myofascial Pain focused on measuring Blood flow, Glucose, lactic acid

Eligibility Criteria

21 Years - 49 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • University of Colorado Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Trigger point treatment

Ultrasound

Arm Description

Trigger point release

Sham US at Trigger point

Outcomes

Primary Outcome Measures

Change in Blood Flow as measured by microdialysis

Secondary Outcome Measures

Change in Glucose as measured by microdialysis
Change in Lactate as measured by microdialysis
Change in Pyruvate as measured by microdialysis

Full Information

First Posted
March 2, 2015
Last Updated
August 30, 2017
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT02389140
Brief Title
Blood Flow Within Active Myofascial Trigger Points Following Massage
Official Title
Blood Flow Within Active Myofascial Trigger Points Following Massage
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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. The long-term goal is to understand how therapeutic intervention affects the physiology of the MTrP. The objective of the proposed research is to assess, in a placebo controlled trial, the effectiveness of trigger point release massage (also known as ischemic compression) on blood flow at an active MTrP. The central hypothesis is that the contraction nodule of an active MTrP is characterized by an ischemic state comprised of reduced blood flow and subsequent dysregulation in carbohydrate metabolism. The investigators hypothesize that trigger point release (TPR) can positively impact blood flow leading to a change in high energy carbohydrate tension. The present study has been formulated, in part, from a preliminary study conducted by the investigators, which supports reduced blood flow and physiological disruption at active MTrPs. The proposed research will provide a physiological basis for massage to corroborate subjective reports of reduced pain sensitivity, impart credibility to treatment techniques, and provide insight into a mechanism of action for healing the MTrP.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Pain, Tension-type Headache
Keywords
Blood flow, Glucose, lactic acid

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Trigger point treatment
Arm Type
Experimental
Arm Description
Trigger point release
Arm Title
Ultrasound
Arm Type
Sham Comparator
Arm Description
Sham US at Trigger point
Intervention Type
Other
Intervention Name(s)
Trigger point release
Intervention Description
Trigger point therapy
Intervention Type
Other
Intervention Name(s)
Ultrasound
Intervention Description
sham ultrasound
Primary Outcome Measure Information:
Title
Change in Blood Flow as measured by microdialysis
Time Frame
1 hr pre intervention and 1 hr post intervention
Secondary Outcome Measure Information:
Title
Change in Glucose as measured by microdialysis
Time Frame
1 hr pre intervention and 1 hr post intervention
Title
Change in Lactate as measured by microdialysis
Time Frame
1 hr pre intervention and 1 hr post intervention
Title
Change in Pyruvate as measured by microdialysis
Time Frame
1 hr pre intervention and 1 hr post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Albert Moraska, PhD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30092205
Citation
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.
Results Reference
derived

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Blood Flow Within Active Myofascial Trigger Points Following Massage

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