Expired Study
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Aurora, Colorado 80045


Purpose:

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.


Study 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. 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.


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


Study is Available At:


Original ID:

14-1582


NCT ID:

NCT02389140


Secondary ID:

UL1TR001082


Study Acronym:


Brief Title:

Blood Flow Within Active Myofascial Trigger Points Following Massage


Official Title:

Blood Flow Within Active Myofascial Trigger Points Following Massage


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

21 Years


Maximum Age:

49 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Colorado, Denver


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

28


Enrollment Type:

Actual


Overall Contact Information

Official Name:Albert Moraska, PhD
Principal Investigator
University of Colorado, Denver

Study Dates

Start Date:March 2015
Completion Date:January 2017
Completion Type:Actual
Primary Completion Date:December 2016
Primary Completion Type:Actual
Verification Date:August 2017
Last Changed Date:August 30, 2017
First Received Date:March 2, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Change in Pyruvate as measured by microdialysis
Time Frame:1 hr pre intervention and 1 hr post intervention
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change in Lactate as measured by microdialysis
Time Frame:1 hr pre intervention and 1 hr post intervention
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change in Glucose as measured by microdialysis
Time Frame:1 hr pre intervention and 1 hr post intervention
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Change in Blood Flow as measured by microdialysis
Time Frame:1 hr pre intervention and 1 hr post intervention
Safety Issues:False

Study Interventions

Intervention Type:Other
Name:Trigger point release
Description:Trigger point therapy
Arm Name:Trigger point treatment
Intervention Type:Other
Name:Ultrasound
Description:sham ultrasound
Arm Name:Ultrasound

Study Arms

Study Arm Type:Sham Comparator
Arm Name:Ultrasound
Description:Sham US at Trigger point
Study Arm Type:Experimental
Arm Name:Trigger point treatment
Description:Trigger point release

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Colorado, Denver

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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