Myofascial PainNCT02389140
Blood Flow Within Active Myofascial Trigger Points Following Massage
A study testing Trigger point release and Ultrasound in people with Myofascial Pain and Tension-type Headache, run by University of Colorado, Denver at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 49 years
- Conditions the study is for
- Myofascial Pain, Tension-type Headache
- What is being tested?
- Trigger point release and Ultrasound
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 49 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Hospital
Aurora, Colorado, 80045
About this study
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.
Read the 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.
- Conditions
- Myofascial Pain, Tension-type Headache
- Being tested
- Trigger point release, Ultrasound
- Keywords
- Blood flow, Glucose, lactic acid
- Medical subject headings
- Tension-Type Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trigger point releaseOther
Trigger point therapy
UltrasoundOther
sham ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Trigger point treatment | Experimental | Trigger point release Receives: Other: Trigger point release |
| Ultrasound | Sham comparator | Sham US at Trigger point Receives: Other: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Blood Flow as measured by microdialysis
Measured: 1 hr pre intervention and 1 hr post intervention
Secondary outcomes (3)
Change in Glucose as measured by microdialysis
Measured: 1 hr pre intervention and 1 hr post intervention
Change in Lactate as measured by microdialysis
Measured: 1 hr pre intervention and 1 hr post intervention
Change in Pyruvate as measured by microdialysis
Measured: 1 hr pre intervention and 1 hr post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myofascial PainStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Albert Moraska, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02389140
- Sponsor's protocol ID
- 14-1582
- Other IDs
- UL1TR001082
- Status last verified
- Aug 2017
- First submitted
- 2 Mar 2015
- Last updated
- 1 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 30092205
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Flow Within Active Myofascial Trigger Points Following Massage
- ClinicalTrials.gov ID
- NCT02389140
- Acronym / sponsor ID
- 14-1582
- Conditions
- Myofascial Pain, Tension-type Headache
- Keywords
- Blood flow, Glucose, lactic acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 17 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trigger point treatment | Experimental | Other: Trigger point releaseTrigger point release |
| Ultrasound | Sham comparator | Other: UltrasoundSham US at Trigger point |
Who may qualify
- Ages
- 21 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Chronic or episodic tension-type headache
- active MTrP in upper trapezius
- age 21-49
- BMI between 18.5-24.9
- either gender
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trigger point releaseTrigger point therapy | Other | Trigger point treatment |
| Ultrasoundsham ultrasound | Other | Ultrasound |
Primary outcome
Change in Blood Flow as measured by microdialysis
Time frame: 1 hr pre intervention and 1 hr post intervention
3 secondary outcomes
Change in Glucose as measured by microdialysis
Time frame: 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
Change in Pyruvate as measured by microdialysis
Time frame: 1 hr pre intervention and 1 hr post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2017.
- Derived from this study: PubMed 30092205Moraska 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Albert Moraska, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trigger point release and Ultrasound in people with Myofascial Pain and Tension-type Headache, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Blood Flow as measured by microdialysis (time frame: 1 hr pre intervention and 1 hr post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02389140, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2017.