Invasive Techniques in Trigger Points

NCT ID: NCT05478928

Last Updated: 2022-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-15

Study Completion Date

2023-08-15

Brief Summary

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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.

Detailed Description

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Conditions

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Trigger Point Pain, Myofascial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Dynamic dry needling

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

Group Type EXPERIMENTAL

Dynamic dry needling

Intervention Type OTHER

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.

Fixed dose dynamic MEP

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

Group Type EXPERIMENTAL

Fixed dose dynamic MEP

Intervention Type DEVICE

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).

Static dry needling:

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

Group Type EXPERIMENTAL

Static Dry needling

Intervention Type OTHER

An acupuncture needle of 0.3 x 25 mm will be introduced perpendicularly into the upper trapezius trigger point for 120 seconds.

Fixed dose static MEP

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

Group Type EXPERIMENTAL

Fixed dose static MEP

Intervention Type DEVICE

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

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

Group Type EXPERIMENTAL

Algorithm-based dose static MEP

Intervention Type DEVICE

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

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

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).

Intervention Type DEVICE

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.

Intervention Type OTHER

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).

Intervention Type 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.

Intervention Type DEVICE

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

48 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Maimonides University

OTHER

Sponsor Role lead

Responsible Party

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Oscar Ronzio

Head of Physiotherapy program

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Universidad Maimónides

Buenos Aires, Buenos Aires F.D., Argentina

Site Status RECRUITING

Countries

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Argentina

Central Contacts

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Oscar Ronzio, DHSc PT

Role: CONTACT

541149051140

Facility Contacts

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Oscar Ronzio, DHSc PT

Role: primary

+541149051140

References

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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.

Reference Type DERIVED
PMID: 40802423 (View on PubMed)

Other Identifiers

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863

Identifier Type: -

Identifier Source: org_study_id

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