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Invasive Techniques in Trigger Points

Not Applicable
Conditions
Trigger Point Pain, Myofascial
Interventions
Other: Dynamic dry needling
Device: Algorithm-based dose static MEP
Device: Fixed dose dynamic MEP
Other: Static Dry needling
Device: Fixed dose static MEP
Other: Placebo
Registration Number
NCT05478928
Lead Sponsor
Maimonides University
Brief 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).

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
60
Inclusion Criteria
  1. Neck pain during the last 6 months
  2. Presence of a palpable taut band in the upper trapezius
  3. Presence of a hypersensitive tender spot in the taut band, with local or referred pain elicitation in response to compression
  4. PPT less than 3 Kg/cm2
Exclusion Criteria
  1. Previous cervical and/or shoulder surgical intervention.
  2. Phobia to needles.
  3. Temporomandibular disorders.
  4. Medicated with anticoagulants
  5. Still receiving a treatment for the myofascial trigger points (Physical therapy, NSAIDs, etc.)
  6. Diagnosis of fibromyalgia.
  7. Radiculopathies and/or radicular pain
  8. Whiplash related neck pain
  9. Migraines
  10. Dizziness
  11. Endocrinal diseases
  12. Being pregnant
  13. Cancer

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Dynamic dry needlingDynamic dry needlingDynamic dry needling will be done in the upper trapezius trigger point.
Algorithm-based dose static MEPAlgorithm-based dose static MEPLow intensity percutaneous electrolysis will be applied in the upper trapezius trigger point with an algorithm-based dose.
Fixed dose dynamic MEPFixed dose dynamic MEPDynamic low intensity percutaneous electrolysis will be applied in the upper trapezius trigger point with a fixed dose.
Static dry needling:Static Dry needlingStatic dry needling will be done in the upper trapezius trigger point.
Fixed dose static MEPFixed dose static MEPStatic low intensity percutaneous electrolysis will be applied in the upper trapezius trigger point with a fixed dose.
PlaceboPlaceboAn acupuncture needle will be slightly introduced into the upper trapezius trigger point.
Primary Outcome Measures
NameTimeMethod
Pressure Pain Threshold (PPT) - 10 minutes10 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.

Surface electromyography at rest - 24 hours24 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.

Surface electromyography at maximum voluntary contraction - 48 hours48 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.

Pressure Pain Threshold (PPT) - 48 hours48 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.

Surface electromyography at rest - BaselineBaseline

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.

Surface electromyography at rest - 48 hours48 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.

Surface electromyography at rest - Day 7Day 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.

Surface electromyography at maximum voluntary contraction - BaselineBaseline

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.

Surface electromyography at maximum voluntary contraction - 24 hours24 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.

Surface electromyography at maximum voluntary contraction - Day 7Day 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.

Pressure Pain Threshold (PPT) - BaselineBaseline

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.

Pressure Pain Threshold (PPT) - 24 hours24 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.

Pressure Pain Threshold (PPT) - Day 7Day 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.

Surface electromyography at rest - 10 minutes10 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.

Surface electromyography at maximum voluntary contraction - 10 minutes10 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.

Secondary Outcome Measures
NameTimeMethod
Visual Analogue Scale of the procedureImmediately after the intervention

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.

Post-needling sorenessFour times per day (in the morning, before lunch, in the afternoon, and in the evening) during the seven days following intervention.

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.

DoseImmediately after the intervention

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

Trial Locations

Locations (1)

Universidad Maimónides

🇦🇷

Ciudad Autonoma de Buenos Aires, Caba, Argentina

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