Invasive Techniques in Trigger Points (ITTP)

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).

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.

Study Overview

• Status: Recruiting
• Conditions: Trigger Point Pain, Myofascial
• Intervention / Treatment: Other: Dynamic dry needling; Device: Fixed dose dynamic MEP; Other: Static Dry needling; Device: Fixed dose static MEP; Device: Algorithm-based dose static MEP; Other: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Oscar Ronzio, DHSc PT; Phone Number: 541149051140; Email: ronzio.oscar@maimonides.edu

Study Locations

• Argentina
  • Caba
    • Ciudad Autonoma de Buenos Aires, Caba, Argentina, 1405
      • Recruiting
      • Universidad Maimonides
      • Contact: Oscar Ronzio, DHSc PT; Phone Number: +541149051140; Email: ronzio.oscar@maimonides.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 48 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Dynamic dry needling; Dynamic dry needling will be done in the upper trapezius trigger point.	Other: Dynamic dry needling; 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.
EXPERIMENTAL: Fixed dose dynamic MEP; Dynamic low intensity percutaneous electrolysis will be applied in the upper trapezius trigger point with a fixed dose.	Device: Fixed 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).
EXPERIMENTAL: Static dry needling: Static dry needling will be done in the upper trapezius trigger point.	Other: Static Dry needling; An acupuncture needle of 0.3 x 25 mm will be introduced perpendicularly into the upper trapezius trigger point for 120 seconds.
EXPERIMENTAL: Fixed dose static MEP; Static low intensity percutaneous electrolysis will be applied in the upper trapezius trigger point with a fixed dose.	Device: Fixed 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).
EXPERIMENTAL: Algorithm-based dose static MEP; Low intensity percutaneous electrolysis will be applied in the upper trapezius trigger point with an algorithm-based dose.	Device: Algorithm-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.
PLACEBO_COMPARATOR: Placebo; An acupuncture needle will be slightly introduced into the upper trapezius trigger point.	Other: Placebo; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Immediately after the intervention
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.	Four times per day (in the morning, before lunch, in the afternoon, and in the evening) during the seven days following intervention.
Dose	To determine the amount of electric charge applied, the millicoulombs (mC) informed in the MEP device will be recorded.	Immediately after the intervention

Collaborators and Investigators

• Sponsor: Maimonides University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): August 15, 2022
• Primary Completion (ANTICIPATED): August 15, 2023
• Study Completion (ANTICIPATED): August 15, 2023

Study Registration Dates

• First Submitted: July 25, 2022
• First Submitted That Met QC Criteria: July 26, 2022
• First Posted (ACTUAL): July 28, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 28, 2022
• Last Update Submitted That Met QC Criteria: July 26, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Percutaneous; Physical Therapy Modalities; Trigger point; Electrolysis
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Muscular Diseases; Myofascial Pain Syndromes
• Other Study ID Numbers: 863

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No