Dry Needling Versus Intramuscular Stimulation in the Management of the Myofascial Trigger Points

February 23, 2021 updated by: Prof. Dr. Daniel Pecos Martín, University of Alcala

Effectiveness of Dry Needling and Intramuscular Electrostimulation in the Treatment of Myofascial Trigger Points in Patients With Neck Pain

Hypothesis The application of intramuscular electrostimulation will be more effectiveness than the dry needling in myofascial trigger points treatment.

Objetives:

To determine the effectiveness of intramuscular electrostimulation in the treatment of trigger points of the levator scapula muscle for the improvement of pain in mechanical cervicalgia.

Participants: Subjects with diagnosed of myofascial pain syndrome in cervical region and active trigger points in levator scapulae muscle, randomly assigned to experimental or control group.

Intervention: Control group: one session of dry needling in active trigger points; experimental group: one session of intramuscular stimulation in active trigger points.

Main Outcomes Measures: Pain, pressure pain threshold (PPT), active cervical range of motion and strength muscle . The measures will be taken before, after and one week after the interventions.

Study Overview

Detailed Description

The muscle pain is one of the most common forms of musculoskeletal pain. Within muscular pain, the presence of myofascial trigger points (PG) in the musculature is a important and prevalent problem.

Currently one the techniques most used in the treatment of PG is dry needling. Dry needling has been shown effective in the treatment of neck pain associated with PGs.

To our knowledge, there are no studies that they have compared the effectiveness of dry needling and intramuscular stimulation by applying an electric current.

This study is a randomized clinical trial that aims to demonstrate that the application of an electric current associated with dry needling in the treatment of PG.

In this study we will treat subjects with cervical pain who they have active PGs in the levator scapulae muscle.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Madrid
      • Alcala de Henares, Madrid, Spain, 28806
        • Patricia Martinez Merinero

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Cervical pain.
  • Active trigger points in levator scapulae muscle

Exclusion Criteria:

  • Pain Irradiation toward upper limb
  • Psychological disorders
  • Whiplash.
  • Neuropathic symptoms
  • Cervical and / or Shoulder Spine Surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
Dry needling technique and the application of a rectangular, biphasic, asymmetric analgesic electric current by selecting a frequency of 2 Hz with a pulse width 40 μs, with an intensity located at the tolerance threshold and for a time of 20 minutes.
Dry needling technique and the application of electric stimulation of levator scapulae PG
Active Comparator: Control group
Dry technique in PG.The needle will be moved in-and-out into different directions to encounter sensitive spots in PG region.
Treatment of PG with a filiform needle in levator scapulae muscle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pressure Pain Threshold (PPT)
Time Frame: Change from baseline at one week
An algometer Wagner FPI 10-WA will be used to determine the PPT in levator scapulae trigger points
Change from baseline at one week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Visual Analogue Scale
Time Frame: Change from baseline at one week
The pain VAS is a unidimensional measure of pain intensity, which has been widely used in diverse adult populations. The VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured from 0 (no pain) to 10 (maximum pain). All the subjects will showed their pain level.
Change from baseline at one week
Strength in cervical latero-flexion
Time Frame: Change from baseline at one week
Dynamic dynamometry with MicroFet-2 will be used while patients will positioned in seated. From this position, patients will performed lateral - flexion
Change from baseline at one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Tomás Gallego-Izquierdo, Doctor, Alcala University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

January 16, 2017

First Submitted That Met QC Criteria

January 16, 2017

First Posted (Estimate)

January 19, 2017

Study Record Updates

Last Update Posted (Actual)

February 26, 2021

Last Update Submitted That Met QC Criteria

February 23, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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