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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02389140
Other study ID # 14-1582
Secondary ID UL1TR001082
Status Completed
Phase N/A
First received March 2, 2015
Last updated August 30, 2017
Start date March 2015
Est. completion date January 2017

Study information

Verified date August 2017
Source University of Colorado, Denver
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date January 2017
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender All
Age group 21 Years to 49 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Trigger point release
Trigger point therapy
Ultrasound
sham ultrasound

Locations

Country Name City State
United States University of Colorado Hospital Aurora Colorado

Sponsors (1)

Lead Sponsor Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Blood Flow as measured by microdialysis 1 hr pre intervention and 1 hr post intervention
Secondary Change in Glucose as measured by microdialysis 1 hr pre intervention and 1 hr post intervention
Secondary Change in Lactate as measured by microdialysis 1 hr pre intervention and 1 hr post intervention
Secondary Change in Pyruvate as measured by microdialysis 1 hr pre intervention and 1 hr post intervention
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