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Clinical Trials/NCT05478928
NCT05478928
Unknown
Not Applicable

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

Maimonides University1 site in 1 country60 target enrollmentAugust 15, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Trigger Point Pain, Myofascial
Sponsor
Maimonides University
Enrollment
60
Locations
1
Primary Endpoint
Pressure Pain Threshold (PPT) - 10 minutes
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 15, 2022
End Date
August 15, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Maimonides University
Responsible Party
Principal Investigator
Principal Investigator

Oscar Ronzio

Head of Physiotherapy program

Maimonides University

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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
  • Endocrinal diseases
  • Being pregnant

Outcomes

Primary Outcomes

Pressure Pain Threshold (PPT) - 10 minutes

Time Frame: 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.

Surface electromyography at rest - 24 hours

Time Frame: 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.

Surface electromyography at maximum voluntary contraction - 48 hours

Time Frame: 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.

Pressure Pain Threshold (PPT) - 48 hours

Time Frame: 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.

Surface electromyography at rest - Baseline

Time Frame: 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.

Surface electromyography at rest - 48 hours

Time Frame: 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.

Surface electromyography at rest - Day 7

Time Frame: 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.

Surface electromyography at maximum voluntary contraction - Baseline

Time Frame: 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.

Surface electromyography at maximum voluntary contraction - 24 hours

Time Frame: 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.

Surface electromyography at maximum voluntary contraction - Day 7

Time Frame: 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.

Pressure Pain Threshold (PPT) - Baseline

Time Frame: 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.

Pressure Pain Threshold (PPT) - 24 hours

Time Frame: 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.

Pressure Pain Threshold (PPT) - Day 7

Time Frame: 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.

Surface electromyography at rest - 10 minutes

Time Frame: 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.

Surface electromyography at maximum voluntary contraction - 10 minutes

Time Frame: 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.

Secondary Outcomes

  • 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 Sites (1)

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