Myofascial Trigger Point PainNCT03708107
Percutaneous Microelectrolysis (MEP) Versus Ischemic Compression in Miofascial Trigger Points
A study testing MEP and Ischemic compression in people with Myofascial Trigger Point Pain, run by Instituto Universitario de Ciencias de la Salud Fundación H.A. Barceló at 1 site in Argentina.
Trial summary
The Percutaneous Microelectrolysis ® (MEP®) is a technique that employs a galvanic current up to 990 uA, which is applied percutaneously with an acupuncture needle connected to the cathode. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Myofascial Trigger Point Pain
- What is being tested?
- MEP and Ischemic compression
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteArgentina
- Study dates
- 22 Oct 2018to 10 Dec 2019
- 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers
- Between 18 to 30 years old.
- Who referred MTrP in the upper trapezious.
- PPT equal or less than 3 KgF/cm2
Who cannot join
- Being pregnant.
- Taking analgesic medication at least 24 hours before the intervention.
- Being in physical therapy treatment.
- Needle phobia.
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Oscar Ronzio
Ciudad Autónoma de Buenos Aire, Buenos Aires F.D., 1428
About this study
Official title: Short Term Effects in Pressure-pain Threshold of Percutaneous Galvanic Microcurrent Versus Ischemic Compression in the Trapezius Trigger Points
The Percutaneous Microelectrolysis ® (MEP®) is a technique that employs a galvanic current up to 990 uA, which is applied percutaneously with an acupuncture needle connected to the cathode. Although it is used in tendinopathies, trigger points and muscle injuries, among other conditions, its bases are mostly empirical and there is lack of evidence.
Ischemic compression is a manual therapy that is usually applied in muscle pain.
Read more
Myofascial Pain Syndrome (MPS) usually presents painful myofascial trigger points (MTrPs). One methodology used to quantify the pain in MPS is the algometry, which measures the pressure pain threshold (PPT).
The aim of this study was to compare the effects of MEP® with ischemic compression on MTrPs with algometry.
- Conditions
- Myofascial Trigger Point Pain
- Being tested
- MEP, Ischemic compression
- Keywords
- galvanic current, electrolysis, myofascial trigger point, percutaneous microelectrolysis, dry needling, ischemic compression
- Medical subject headings
- Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEPDevice
Also called Percutaneous microelectrolysis, Percutaneous galvanic microcurrent
MEP® will be applied with an acupuncture needle (0,30 x 25 mm). The needle will be introduced perpendicularly to the MTrP with 100 uA and then increased up to 600 uA. The current will be paused if the patient feels a burning sensation, pain or oppression, waiting up to the patient feels no discomfort. The procedure will be repeated as many times is necessary until the patient do not feel any discomfort for more than 1 minute.
Ischemic compressionOther
Ischemic compression will be applied perpendicularly to the MTrP, increasing gradually the pression until the patient refers the maximum tolerable pain. This pressure will be applied for 1 minute.
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous Microelectrolysis (MEP) | Experimental | Principal MTrP will be detected by digital palpation in the upper trapezius. Algometry will be used to determine if the Pain Pressure Threshold (PPT) is equal or less than 3 KgF/cm2. If not, the patient will be not included. A mark will be done in the MTrP.
MEP® will be applied with a 0,30 x 25 mm acupuncture needle. The needle will be introduced perpendicularly to the MTrP with 100 uA and then increased up to 600 uA. The current will be paused if the patient feels a burning sensation, pain or oppression, waiting up to the patient feels no discomfort. The procedure will be repeated as many times is necessary until the patient do not feel any discomfort for more than 1 minute.
Algometry will be done immediately finished the intervention, after 10 minutes and at 24 hs. Receives: Device: MEP |
| Ischemic compression | Experimental | Principal MTrP will be detected by digital palpation in the upper trapezius. Algometry will be used to determine if the Pain Pressure Threshold (PPT) is equal or less than 3 KgF/cm2. If not, the patient will be not included. A mark will be done in the MTrP with a marker.
Ischemic compression will be applied perpendicularly to the MTrP, increasing gradually the pression until the patient refers the maximum tolerable pain. This pressure will be applied for 1 minute.
Algometry will be done immediately finished the intervention, after 10 minutes and at 24 hs. Receives: Other: Ischemic compression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preasure Pain Threshold (PPT)
Algometry is used to measure the Preasure Pain Threshold (PPT). PPT is defined as the minimum force applied which induces pain. It was applied in the Miofascial Trigger points.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start22 Oct 2018
- Primary completion10 Dec 2019
- Study completion10 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial Trigger Point PainStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Universitario de Ciencias de la Salud Fundación H.A. Barceló
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oscar Ronzio, Instituto Universitario de Ciencias de la Salud Fundación H.A. Barceló
- Investigators
- Oscar Ronzio, Study director, I.U. Fundación H.A. Barceló - U. Maimónides - U. Nacional Arturo Jauretche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03708107
- Sponsor's protocol ID
- MKC18G11
- Other IDs
- U1111-1222-0977
- Status last verified
- Dec 2019
- First submitted
- 11 Oct 2018
- Last updated
- 23 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at www.mepsport.com
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Effects in Pressure-pain Threshold of Percutaneous Galvanic Microcurrent Versus Ischemic Compression in the Trapezius Trigger Points
- ClinicalTrials.gov ID
- NCT03708107
- Acronym / sponsor ID
- MKC18G11
- Conditions
- Myofascial Trigger Point Pain
- Keywords
- galvanic current, electrolysis, myofascial trigger point, percutaneous microelectrolysis, dry needling, ischemic compression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Instituto Universitario de Ciencias de la Salud Fundación H.A. BarcelóUniversity, hospital or other
- Study start
- 22 Oct 2018 (actual)
- Primary completion
- 10 Dec 2019 (actual)
- Study completion
- 10 Dec 2019 (actual)
- First posted
- 17 Oct 2018 (actual)
- 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 Percutaneous Microelectrolysis ® (MEP®) is a technique that employs a galvanic current up to 990 uA, which is applied percutaneously with an acupuncture needle connected to the cathode. Although it is used in tendinopathies, trigger points and muscle injuries, among other conditions, its bases are mostly empirical and there is lack of evidence.
Ischemic compression is a manual therapy that is usually applied in muscle pain.
Myofascial Pain Syndrome (MPS) usually presents painful myofascial trigger points (MTrPs). One methodology used to quantify the pain in MPS is the algometry, which measures the pressure pain threshold (PPT).
The aim of this study was to compare the effects of MEP® with ischemic compression on MTrPs with algometry.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Percutaneous Microelectrolysis (MEP) | Experimental | Device: MEPPrincipal MTrP will be detected by digital palpation in the upper trapezius. Algometry will be used to determine if the Pain Pressure Threshold (PPT) is equal or less than 3 KgF/cm2. If not, the patient will be not included. A mark will be done in the MTrP. MEP® will be applied with a 0,30 x 25 mm acupuncture needle. The needle will be introduced perpendicularly to the MTrP with 100 uA and then increased up to 600 uA. The current will be paused if the patient feels a burning sensation, pain or oppression, waiting up to the patient feels no discomfort. The procedure will be repeated as many times is necessary until the patient do not feel any discomfort for more than 1 minute. Algometry will be done immediately finished the intervention, after 10 minutes and at 24 hs. |
| Ischemic compression | Experimental | Other: Ischemic compressionPrincipal MTrP will be detected by digital palpation in the upper trapezius. Algometry will be used to determine if the Pain Pressure Threshold (PPT) is equal or less than 3 KgF/cm2. If not, the patient will be not included. A mark will be done in the MTrP with a marker. Ischemic compression will be applied perpendicularly to the MTrP, increasing gradually the pression until the patient refers the maximum tolerable pain. This pressure will be applied for 1 minute. Algometry will be done immediately finished the intervention, after 10 minutes and at 24 hs. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy volunteers
- Between 18 to 30 years old.
- Who referred MTrP in the upper trapezious.
- PPT equal or less than 3 KgF/cm2
Key exclusion criteria (4 listed)
- Being pregnant.
- Taking analgesic medication at least 24 hours before the intervention.
- Being in physical therapy treatment.
- Needle phobia.
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 |
|---|---|---|
| MEPAlso: Percutaneous microelectrolysis, Percutaneous galvanic microcurrentMEP® will be applied with an acupuncture needle (0,30 x 25 mm). The needle will be introduced perpendicularly to the MTrP with 100 uA and then increased up to 600 uA. The current will be paused if the patient feels a burning sensation, pain or oppression, waiting up to the patient feels no discomfort. The procedure will be repeated as many times is necessary until the patient do not feel any discomfort for more than 1 minute. | Device | Percutaneous Microelectrolysis (MEP) |
| Ischemic compressionIschemic compression will be applied perpendicularly to the MTrP, increasing gradually the pression until the patient refers the maximum tolerable pain. This pressure will be applied for 1 minute. | Other | Ischemic compression |
Primary outcome
Preasure Pain Threshold (PPT)
Time frame: 24 hours
Algometry is used to measure the Preasure Pain Threshold (PPT). PPT is defined as the minimum force applied which induces pain. It was applied in the Miofascial Trigger points.
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 23 Dec 2019.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at www.mepsport.com
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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.
Oscar Ronzio study director
I.U. Fundación H.A. Barceló - U. Maimónides - U. Nacional Arturo Jauretche
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MEP and Ischemic compression in people with Myofascial Trigger Point Pain, run by Instituto Universitario de Ciencias de la Salud Fundación H.A. Barceló at 1 site in Argentina.
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 4 inclusion and 4 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 23 Dec 2019. 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 Argentina. 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. 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?
Preasure Pain Threshold (PPT) (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Dec 2019.