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Invasive Techniques in Trigger Points

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05478928
Acronym
ITTP
Enrollment
60
Registered
2022-07-28
Start date
2022-08-15
Completion date
2023-08-15
Last updated
2022-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trigger Point Pain, Myofascial

Keywords

Trigger point, Percutaneous, Electrolysis, Physical Therapy Modalities

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.

Interventions

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.

DEVICEFixed dose dynamic MEP

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).

OTHERStatic Dry needling

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

DEVICEFixed dose static MEP

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).

DEVICEAlgorithm-based dose static MEP

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.

OTHERPlacebo

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.

Sponsors

Maimonides University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 48 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Surface electromyography at maximum voluntary contraction - Day 7Day 7Electromyography (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 - 10 minutes10 minutesElectromyography (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 hoursElectromyography (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 - 48 hours48 hoursElectromyography (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) - BaselineBaselineAlgometry 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) - 10 minutes10 minutesAlgometry 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 hoursAlgometry 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) - 48 hours48 hoursAlgometry 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 7Algometry 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 - BaselineBaselineElectromyography (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 - 10 minutes10 minutesElectromyography (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 - 24 hours24 hoursElectromyography (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 hoursElectromyography (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 7Electromyography (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 - BaselineBaselineElectromyography (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

MeasureTime frameDescription
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 interventionTo determine the amount of electric charge applied, the millicoulombs (mC) informed in the MEP device will be recorded.
Visual Analogue Scale of the procedureImmediately after the interventionTo 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.

Countries

Argentina

Contacts

Primary ContactOscar Ronzio, DHSc PT
ronzio.oscar@maimonides.edu541149051140

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026