Invasive Techniques in Trigger Points (ITTP)

Maimonides University

Status: Enrolling

Conditions: Trigger Point Pain, Myofascial

Treatments: Other: Static Dry needling; Other: Placebo; Other: Dynamic dry needling; Device: Fixed dose dynamic MEP; Device: Fixed dose static MEP; Device: Algorithm-based dose static MEP

Study type: Interventional

Funder types: Other

Identifiers

NCT05478928

863

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 48 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

60 participants in 6 patient groups, including a placebo group

Dynamic dry needling

Experimental group

Description:

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

Treatment:

Other: Dynamic dry needling

Fixed dose dynamic MEP

Experimental group

Description:

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

Treatment:

Device: Fixed dose dynamic MEP

Static dry needling:

Experimental group

Description:

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

Treatment:

Other: Static Dry needling

Fixed dose static MEP

Experimental group

Description:

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

Treatment:

Device: Fixed dose static MEP

Algorithm-based dose static MEP

Experimental group

Description:

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

Treatment:

Device: Algorithm-based dose static MEP

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo