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Trigger Point Pain, MyofascialITTPNCT05478928

Invasive Techniques in Trigger Points

A study testing Dynamic dry needling, Fixed dose dynamic MEP and Static Dry needling in people with Trigger Point Pain, Myofascial, run by Maimonides University at 1 site in Argentina.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Myofascial pain syndrome (MPS) is present in up to 87% of the patients that present pain. 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). Read more about this study

Who is it for?
Ages 18 to 48 yearsHealthy volunteers can take part
Conditions the study is for
Trigger Point Pain, Myofascial
What is being tested?
Dynamic dry needling, Fixed dose dynamic MEP and Static Dry needling
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteArgentina
Study dates
15 Aug 2022to 15 Aug 2023
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 48 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Neck pain during the last 6 months
  • Presence of a palpable taut band in the upper trapezius
  • Presence of a hypersensitive tender spot in the taut band, with local or referred pain elicitation in response to compression
  • PPT less than 3 Kg/cm2

Who cannot join

  • Previous cervical and/or shoulder surgical intervention.
  • Phobia to needles.
  • Temporomandibular disorders.
  • Medicated with anticoagulants
  • Still receiving a treatment for the myofascial trigger points (Physical therapy, NSAIDs, etc.)
  • Diagnosis of fibromyalgia.
Show all 13Show fewer
  • Radiculopathies and/or radicular pain
  • Whiplash related neck pain
  • Migraines
  • Dizziness
  • Endocrinal diseases
  • Being pregnant
  • Cancer

Trial locations and contacts

1 site in 1 country.

Oscar Ronzio, DHSc PT contact

541149051140

ronzio.oscar@maimonides.edu

Argentina1 site, 1 recruiting
  • Universidad Maimónides

    Buenos Aires, Buenos Aires F.D., 1405

    Oscar Ronzio, DHSc PT, +541149051140, ronzio.oscar@maimonides.edu

    Recruiting

Other trials in Argentina

About this study

Official title: Effects of Invasive Techniques in Myofascial Trigger Points: A Randomized Controlled Clinical Trial

Myofascial pain syndrome (MPS) is present in up to 87% of the patients that present pain. 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).

Read more

Invasive techniques in physiotherapy have become popular in the last years due to their clinical efficacy and evidence. Percutaneous Microelectrolysis (MEP®) and dry needling are techniques that are already in use for this syndrome.

MEP® is a technique that employs a galvanic current up to 990 microAmperes, which is applied percutaneously with an acupuncture needle connected to the cathode. It is also known as low intensity percutaneous electrolysis.

The aim of this study is to compare the effects in pain and muscle tone (measured with algometry and surface electromyography) of invasive techniques. Healthy subjects between 18 to 48 years old, both sex, presenting MTrPs in upper trapezius will be recruited.

The secondary objectives are to determine the discomfort degree of each technique and if it is better to use MEP® with a fixed dose or with an algorithm in which the dose varies.

The hypothesis, according to our previous studies, is that MEP® generates higher changes in PPT.

Being tested
Dynamic dry needling, Fixed dose dynamic MEP, Static Dry needling, Fixed dose static MEP, Algorithm-based dose static MEP
Keywords
Trigger point, Percutaneous, Electrolysis, Physical Therapy Modalities
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.

  • Dynamic dry needlingOther

    An acupuncture needle of 0.3 x 25 mm will be introduced perpendicularly into the upper trapezius trigger point. A movement with the needle will be done at 1 Hz for 120 seconds.

  • Fixed dose dynamic MEPDevice

    Cathodic low intensity percutaneous electrolysis will be applied through an acupuncture needle of 0.3 x 25 mm in the upper trapezius trigger point. A movement with the needle will be done at 1 Hz with an intensity of 600 micro-Amperes. If the patient refers discomfort, the procedure will be stopped and resumed totalling 120 seconds (total dose of 72 mC).

  • Static Dry needlingOther

    An acupuncture needle of 0.3 x 25 mm will be introduced perpendicularly into the upper trapezius trigger point for 120 seconds.

  • Fixed dose static MEPDevice

    Cathodic low intensity percutaneous electrolysis will be applied through an acupuncture needle of 0.3 x 25 mm in the upper trapezius trigger point. The therapy will be done statically with an intensity of 600 micro-Amperes. If the patient refers discomfort, the procedure will be stopped and resumed totalling 120 seconds (total dose of 72 mC).

  • Algorithm-based dose static MEPDevice

    Cathodic low intensity percutaneous electrolysis will be applied through an acupuncture needle of 0.3 x 25 mm in the upper trapezius trigger point. The therapy will be done statically, at 600 micro-Amperes. If the patient refers discomfort, the procedure will be stopped and resumed. Treatment will finish when the patient does not refer any discomfort for a period longer than 60 seconds. Total dose in mC will be registered.

  • PlaceboOther

    An acupuncture needle of 0.3 x 25 mm will be introduced perpendicularly up to 3 mm deep into the upper trapezius trigger point for 120 seconds.

Study groups in NCT05478928
Study groupRoleWhat they receive
Dynamic dry needlingExperimentalDynamic dry needling will be done in the upper trapezius trigger point.
Receives: Other: Dynamic dry needling
Fixed dose dynamic MEPExperimentalDynamic low intensity percutaneous electrolysis will be applied in the upper trapezius trigger point with a fixed dose.
Receives: Device: Fixed dose dynamic MEP
Static dry needling:ExperimentalStatic dry needling will be done in the upper trapezius trigger point.
Receives: Other: Static Dry needling
Fixed dose static MEPExperimentalStatic low intensity percutaneous electrolysis will be applied in the upper trapezius trigger point with a fixed dose.
Receives: Device: Fixed dose static MEP
Algorithm-based dose static MEPExperimentalLow intensity percutaneous electrolysis will be applied in the upper trapezius trigger point with an algorithm-based dose.
Receives: Device: Algorithm-based dose static MEP
PlaceboPlacebo comparatorAn acupuncture needle will be slightly introduced into the upper trapezius trigger point.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pressure Pain Threshold (PPT) - Baseline

    Algometry is used to measure the Pressure Pain Threshold (PPT). PPT is defined as the minimum force applied which induces pain. It will be applied in the Myofascial Trigger points.

    Measured: Baseline

  2. Pressure Pain Threshold (PPT) - 10 minutes

    Algometry is used to measure the Pressure Pain Threshold (PPT). PPT is defined as the minimum force applied which induces pain. It will be applied in the Myofascial Trigger points.

    Measured: 10 minutes

  3. Pressure Pain Threshold (PPT) - 24 hours

    Algometry is used to measure the Pressure Pain Threshold (PPT). PPT is defined as the minimum force applied which induces pain. It will be applied in the Myofascial Trigger points.

    Measured: 24 hours

  4. Pressure Pain Threshold (PPT) - 48 hours

    Algometry is used to measure the Pressure Pain Threshold (PPT). PPT is defined as the minimum force applied which induces pain. It will be applied in the Myofascial Trigger points.

    Measured: 48 hours

  5. Pressure Pain Threshold (PPT) - Day 7

    Algometry is used to measure the Pressure Pain Threshold (PPT). PPT is defined as the minimum force applied which induces pain. It will be applied in the Myofascial Trigger points.

    Measured: Day 7

  6. Surface electromyography at rest - Baseline

    Electromyography (EMG) is used to measure muscular electrical activity at rest to determine the basal tone. Peak voltage and root mean square (RMS) voltage will be informed.

    Measured: Baseline

  7. Surface electromyography at rest - 10 minutes

    Electromyography (EMG) is used to measure muscular electrical activity at rest to determine the basal tone. Peak voltage and root mean square (RMS) voltage will be informed.

    Measured: 10 minutes

  8. Surface electromyography at rest - 24 hours

    Electromyography (EMG) is used to measure muscular electrical activity at rest to determine the basal tone. Peak voltage and root mean square (RMS) voltage will be informed.

    Measured: 24 hours

  9. Surface electromyography at rest - 48 hours

    Electromyography (EMG) is used to measure muscular electrical activity at rest to determine the basal tone. Peak voltage and root mean square (RMS) voltage will be informed.

    Measured: 48 hours

  10. Surface electromyography at rest - Day 7

    Electromyography (EMG) is used to measure muscular electrical activity at rest to determine the basal tone. Peak voltage and root mean square (RMS) voltage will be informed.

    Measured: Day 7

  11. Surface electromyography at maximum voluntary contraction - Baseline

    Electromyography (EMG) is used to measure muscular electrical activity at maximum voluntary contraction to determine the recruitment. Peak voltage and RMS voltage will be informed.

    Measured: Baseline

  12. Surface electromyography at maximum voluntary contraction - 10 minutes

    Electromyography (EMG) is used to measure muscular electrical activity at maximum voluntary contraction to determine the recruitment. Peak voltage and RMS voltage will be informed.

    Measured: 10 minutes

  13. Surface electromyography at maximum voluntary contraction - 24 hours

    Electromyography (EMG) is used to measure muscular electrical activity at maximum voluntary contraction to determine the recruitment. Peak voltage and RMS voltage will be informed.

    Measured: 24 hours

  14. Surface electromyography at maximum voluntary contraction - 48 hours

    Electromyography (EMG) is used to measure muscular electrical activity at maximum voluntary contraction to determine the recruitment. Peak voltage and RMS voltage will be informed.

    Measured: 48 hours

  15. Surface electromyography at maximum voluntary contraction - Day 7

    Electromyography (EMG) is used to measure muscular electrical activity at maximum voluntary contraction to determine the recruitment. Peak voltage and RMS voltage will be informed.

    Measured: Day 7

Secondary outcomes (3)
  1. Visual Analogue Scale of the procedure

    To determine how unpleasant the procedure is, the visual analog scale (VAS) will be used.

    Expresed in centimeters.

    Minimum value: 0 Maximum value: 10 A higher score implicates a worse outcome.

    Measured: Immediately after the intervention

  2. Post-needling soreness

    To determine how unpleasant the post-needling soreness is, a pain diary with the visual analog scale (VAS) will be used. The patient will register the pain intensity in the needle area.

    Expresed in centimeters.

    Minimum value: 0 Maximum value: 10 A higher score implicates a worse outcome.

    Measured: Four times per day (in the morning, before lunch, in the afternoon, and in the evening) during the seven days following intervention.

  3. Dose

    To determine the amount of electric charge applied, the millicoulombs (mC) informed in the MEP device will be recorded.

    Measured: Immediately after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2022
  2. Study start15 Aug 2022 (estimated)
  3. Primary completion15 Aug 2023 (estimated)
  4. Study completion15 Aug 2023 (estimated)

Resources

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
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05478928
Sponsor's protocol ID
863
Acronym
ITTP
Status last verified
Jul 2022
First submitted
25 Jul 2022
Last updated
28 Jul 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Girasol CE, Duran NE, D'Almeida SM, Ronzio OA. Toward an algorithm of percutaneous microelectrolysis: a randomized clinical trial on invasive techniques. Sao Paulo Med J. 2025 Aug 11;143(5):e2024164. doi: 10.1590/1516-3180.2024.0164.R1.07032025. eCollection 2025.

    PubMed 40802423

Questions about this trial

What is this clinical trial studying?

A study testing Dynamic dry needling, Fixed dose dynamic MEP and Static Dry needling in people with Trigger Point Pain, Myofascial, run by Maimonides University 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 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: status not confirmed, as of the sponsor's last update on 28 Jul 2022. 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. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Oscar Ronzio, DHSc PT (541149051140, ronzio.oscar@maimonides.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pressure Pain Threshold (PPT) - Baseline (time frame: Baseline). The study lists 15 primary outcomes in all. 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 NCT05478928, 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 28 Jul 2022.

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