Invasive Techniques in Trigger Points
ITTP
Effects of Invasive Techniques in Myofascial Trigger Points: A Randomized Controlled Clinical Trial
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2022
CompletedFirst Posted
Study publicly available on registry
July 28, 2022
CompletedStudy Start
First participant enrolled
August 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 15, 2023
CompletedJuly 28, 2022
July 1, 2022
1 year
July 25, 2022
July 26, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (15)
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.
Baseline
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.
10 minutes
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.
24 hours
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.
48 hours
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.
Day 7
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.
Baseline
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.
10 minutes
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.
24 hours
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.
48 hours
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.
Day 7
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.
Baseline
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.
10 minutes
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.
24 hours
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.
48 hours
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.
Day 7
Secondary Outcomes (3)
Visual Analogue Scale of the procedure
Immediately after the intervention
Post-needling soreness
Four times per day (in the morning, before lunch, in the afternoon, and in the evening) during the seven days following intervention.
Dose
Immediately after the intervention
Study Arms (6)
Dynamic dry needling
EXPERIMENTALDynamic dry needling will be done in the upper trapezius trigger point.
Fixed dose dynamic MEP
EXPERIMENTALDynamic low intensity percutaneous electrolysis will be applied in the upper trapezius trigger point with a fixed dose.
Static dry needling:
EXPERIMENTALStatic dry needling will be done in the upper trapezius trigger point.
Fixed dose static MEP
EXPERIMENTALStatic low intensity percutaneous electrolysis will be applied in the upper trapezius trigger point with a fixed dose.
Algorithm-based dose static MEP
EXPERIMENTALLow intensity percutaneous electrolysis will be applied in the upper trapezius trigger point with an algorithm-based dose.
Placebo
PLACEBO COMPARATORAn acupuncture needle will be slightly introduced into the upper trapezius trigger point.
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.
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).
An acupuncture needle of 0.3 x 25 mm will be introduced perpendicularly into the upper trapezius trigger point for 120 seconds.
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).
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
- Radiculopathies and/or radicular pain
- Whiplash related neck pain
- Migraines
- Dizziness
- Endocrinal diseases
- Being pregnant
- Cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universidad Maimónides
Buenos Aires, Buenos Aires F.D., 1405, Argentina
Related Publications (1)
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.
PMID: 40802423DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Physiotherapy program
Study Record Dates
First Submitted
July 25, 2022
First Posted
July 28, 2022
Study Start
August 15, 2022
Primary Completion
August 15, 2023
Study Completion
August 15, 2023
Last Updated
July 28, 2022
Record last verified: 2022-07