Clinical trial NCT05478928: Invasive Techniques in Trigger Points
Official title: Effects of Invasive Techniques in Myofascial Trigger Points: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Trigger Point Pain, Myofascial
Keywords: Trigger point
Percutaneous
Electrolysis
Physical Therapy Modalities
Lead sponsor: Maimonides University
Sponsor class: OTHER
First posted: 2022-07-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pressure Pain Threshold (PPT) - Baseline
timeFrame: Baseline
measure: Pressure Pain Threshold (PPT) - 10 minutes
timeFrame: 10 minutes
measure: Pressure Pain Threshold (PPT) - 24 hours
timeFrame: 24 hours
measure: Pressure Pain Threshold (PPT) - 48 hours
timeFrame: 48 hours
measure: Pressure Pain Threshold (PPT) - Day 7
timeFrame: Day 7
measure: Surface electromyography at rest - Baseline
timeFrame: Baseline
measure: Surface electromyography at rest - 10 minutes
timeFrame: 10 minutes
measure: Surface electromyography at rest - 24 hours
timeFrame: 24 hours
measure: Surface electromyography at rest - 48 hours
timeFrame: 48 hours
measure: Surface electromyography at rest - Day 7
timeFrame: Day 7
measure: Surface electromyography at maximum voluntary contraction - Baseline
timeFrame: Baseline
measure: Surface electromyography at maximum voluntary contraction - 10 minutes
timeFrame: 10 minutes
measure: Surface electromyography at maximum voluntary contraction - 24 hours
timeFrame: 24 hours
measure: Surface electromyography at maximum voluntary contraction - 48 hours
timeFrame: 48 hours
measure: Surface electromyography at maximum voluntary contraction - Day 7
timeFrame: Day 7
Secondary outcomes:
measure: Visual Analogue Scale of the procedure
timeFrame: Immediately after the intervention
measure: Post-needling soreness
timeFrame: Four times per day (in the morning, before lunch, in the afternoon, and in the evening) during the seven days following intervention.
measure: Dose
timeFrame: Immediately after the intervention
Other outcomes:
Locations:
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Universidad Maimónides
state: Caba
Study officials:
References: