- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02389140
Blood Flow Within Active Myofascial Trigger Points Following Massage
August 30, 2017 updated by: University of Colorado, Denver
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 Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- University of Colorado Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 49 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Trigger point treatment
Trigger point release
|
Trigger point therapy
|
Sham Comparator: Ultrasound
Sham US at Trigger point
|
sham ultrasound
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Blood Flow as measured by microdialysis
Time Frame: 1 hr pre intervention and 1 hr post intervention
|
1 hr pre intervention and 1 hr post intervention
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Glucose as measured by microdialysis
Time Frame: 1 hr pre intervention and 1 hr post intervention
|
1 hr pre intervention and 1 hr post intervention
|
Change in Lactate as measured by microdialysis
Time Frame: 1 hr pre intervention and 1 hr post intervention
|
1 hr pre intervention and 1 hr post intervention
|
Change in Pyruvate as measured by microdialysis
Time Frame: 1 hr pre intervention and 1 hr post intervention
|
1 hr pre intervention and 1 hr post intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Albert Moraska, PhD, University of Colorado, Denver
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2015
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
January 1, 2017
Study Registration Dates
First Submitted
March 2, 2015
First Submitted That Met QC Criteria
March 9, 2015
First Posted (Estimate)
March 17, 2015
Study Record Updates
Last Update Posted (Actual)
September 1, 2017
Last Update Submitted That Met QC Criteria
August 30, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14-1582
- UL1TR001082 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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