Blood Flow Within Active Myofascial Trigger Points Follow... | NCT02389140

Studies
Blood Flow Within Active Myofascial Trigger Points Following Massage

NCT02389140

Sponsor

University of Colorado, Denver

Status

Completed

Last Update Posted

Sep 1, 2017Actual

Enrollment

28Actual

Phase

Not Applicable

Conditions

Myofascial Pain
Tension-type Headache

Interventions

Trigger point release
Ultrasound

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
UL1TR001082	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2015

Primary Completion Date

Dec 2016Actual

Completion Date

Jan 2017Actual

First Submitted Date

Mar 2, 2015

First Submission Date that Met QC Criteria

Mar 9, 2015

First Posted Date

Mar 17, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 30, 2017

Last Update Posted Date

Sep 1, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Trigger point treatment	Experimental	Trigger point release	Other: Trigger point release
Ultrasound	Sham Comparator	Sham US at Trigger point	Other: Ultrasound

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Trigger point release	Other	Trigger point therapy	Trigger point treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Blood Flow as measured by microdialysis		1 hr pre intervention and 1 hr post intervention

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

49 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Albert Moraska, PhD	University of Colorado, Denver	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Colorado Hospital		Aurora	Colorado	80045	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30092205	Derived	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.

ID	Term
D051270	Headache Disorders, Primary
D020773	Headache Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

ID	Term
D000069453	Ultrasonic Waves
D013016	Sound
D011840	Radiation, Nonionizing
D011827	Radiation