Invasive Techniques in Trigger Points

Trigger Point Pain, Myofascial Clinical Trial

— ITTP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05478928
• Other study ID #: 863
• Status: Recruiting
• Phase: N/A
• Start date: August 15, 2022
• Est. completion date: August 15, 2023

Study information

• Verified date: July 2022
• Source: Maimonides University
• Contact: Oscar Ronzio, DHSc PT
• Phone: 541149051140
• Email: ronzio.oscar[@]maimonides.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 15, 2023
• Est. primary completion date: August 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 48 Years

Eligibility

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

Related Conditions & MeSH terms

• Myofascial Pain Syndromes
• Trigger Point Pain, Myofascial

Intervention

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.

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).

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.

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).
• 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.

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.

Locations

Country	Name	City	State
Argentina	Universidad Maimónides	Ciudad Autonoma de Buenos Aires	Caba

Sponsors (1)

Lead Sponsor	Collaborator
Maimonides University

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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.
Secondary	Dose	To determine the amount of electric charge applied, the millicoulombs (mC) informed in the MEP device will be recorded.	Immediately after the intervention