search
Back to results

Invasive Techniques in Trigger Points (ITTP)

Primary Purpose

Trigger Point Pain, Myofascial

Status
Recruiting
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
Dynamic dry needling
Fixed dose dynamic MEP
Static Dry needling
Fixed dose static MEP
Algorithm-based dose static MEP
Placebo
Sponsored by
Maimonides University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trigger Point Pain, Myofascial focused on measuring Trigger point, Percutaneous, Electrolysis, Physical Therapy Modalities

Eligibility Criteria

18 Years - 48 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Universidad MaimónidesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Dynamic dry needling

Fixed dose dynamic MEP

Static dry needling:

Fixed dose static MEP

Algorithm-based dose static MEP

Placebo

Arm Description

Dynamic dry needling will be done in the upper trapezius trigger point.

Dynamic low intensity percutaneous electrolysis will be applied in the upper trapezius trigger point with a fixed dose.

Static dry needling will be done in the upper trapezius trigger point.

Static low intensity percutaneous electrolysis will be applied in the upper trapezius trigger point with a fixed dose.

Low intensity percutaneous electrolysis will be applied in the upper trapezius trigger point with an algorithm-based dose.

An acupuncture needle will be slightly introduced into the upper trapezius trigger point.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
July 25, 2022
Last Updated
July 26, 2022
Sponsor
Maimonides University
search

1. Study Identification

Unique Protocol Identification Number
NCT05478928
Brief Title
Invasive Techniques in Trigger Points
Acronym
ITTP
Official Title
Effects of Invasive Techniques in Myofascial Trigger Points: A Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 15, 2022 (Anticipated)
Primary Completion Date
August 15, 2023 (Anticipated)
Study Completion Date
August 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maimonides University

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trigger Point Pain, Myofascial
Keywords
Trigger point, Percutaneous, Electrolysis, Physical Therapy Modalities

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dynamic dry needling
Arm Type
Experimental
Arm Description
Dynamic dry needling will be done in the upper trapezius trigger point.
Arm Title
Fixed dose dynamic MEP
Arm Type
Experimental
Arm Description
Dynamic low intensity percutaneous electrolysis will be applied in the upper trapezius trigger point with a fixed dose.
Arm Title
Static dry needling:
Arm Type
Experimental
Arm Description
Static dry needling will be done in the upper trapezius trigger point.
Arm Title
Fixed dose static MEP
Arm Type
Experimental
Arm Description
Static low intensity percutaneous electrolysis will be applied in the upper trapezius trigger point with a fixed dose.
Arm Title
Algorithm-based dose static MEP
Arm Type
Experimental
Arm Description
Low intensity percutaneous electrolysis will be applied in the upper trapezius trigger point with an algorithm-based dose.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
An acupuncture needle will be slightly introduced into the upper trapezius trigger point.
Intervention Type
Other
Intervention Name(s)
Dynamic dry needling
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Fixed dose dynamic MEP
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Static Dry needling
Intervention Description
An acupuncture needle of 0.3 x 25 mm will be introduced perpendicularly into the upper trapezius trigger point for 120 seconds.
Intervention Type
Device
Intervention Name(s)
Fixed dose static MEP
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
Algorithm-based dose static MEP
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pressure Pain Threshold (PPT) - Baseline
Description
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.
Time Frame
Baseline
Title
Pressure Pain Threshold (PPT) - 10 minutes
Description
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.
Time Frame
10 minutes
Title
Pressure Pain Threshold (PPT) - 24 hours
Description
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.
Time Frame
24 hours
Title
Pressure Pain Threshold (PPT) - 48 hours
Description
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.
Time Frame
48 hours
Title
Pressure Pain Threshold (PPT) - Day 7
Description
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.
Time Frame
Day 7
Title
Surface electromyography at rest - Baseline
Description
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.
Time Frame
Baseline
Title
Surface electromyography at rest - 10 minutes
Description
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.
Time Frame
10 minutes
Title
Surface electromyography at rest - 24 hours
Description
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.
Time Frame
24 hours
Title
Surface electromyography at rest - 48 hours
Description
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.
Time Frame
48 hours
Title
Surface electromyography at rest - Day 7
Description
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.
Time Frame
Day 7
Title
Surface electromyography at maximum voluntary contraction - Baseline
Description
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.
Time Frame
Baseline
Title
Surface electromyography at maximum voluntary contraction - 10 minutes
Description
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.
Time Frame
10 minutes
Title
Surface electromyography at maximum voluntary contraction - 24 hours
Description
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.
Time Frame
24 hours
Title
Surface electromyography at maximum voluntary contraction - 48 hours
Description
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.
Time Frame
48 hours
Title
Surface electromyography at maximum voluntary contraction - Day 7
Description
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.
Time Frame
Day 7
Secondary Outcome Measure Information:
Title
Visual Analogue Scale of the procedure
Description
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.
Time Frame
Immediately after the intervention
Title
Post-needling soreness
Description
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.
Time Frame
Four times per day (in the morning, before lunch, in the afternoon, and in the evening) during the seven days following intervention.
Title
Dose
Description
To determine the amount of electric charge applied, the millicoulombs (mC) informed in the MEP device will be recorded.
Time Frame
Immediately after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
48 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 Migraines Dizziness Endocrinal diseases Being pregnant Cancer
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Oscar Ronzio, DHSc PT
Phone
541149051140
Email
ronzio.oscar@maimonides.edu
Facility Information:
Facility Name
Universidad Maimónides
City
Ciudad Autonoma de Buenos Aires
State/Province
Caba
ZIP/Postal Code
1405
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oscar Ronzio, DHSc PT
Phone
+541149051140
Email
ronzio.oscar@maimonides.edu

12. IPD Sharing Statement

Learn more about this trial

Invasive Techniques in Trigger Points

We'll reach out to this number within 24 hrs