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

Primary Purpose

Trigger Point Pain, Myofascial, Muscle Pain, Myofascial Pain Syndrome

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Dry needling and electric stimulation
Dry needling
Sponsored by
University of Alcala
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trigger Point Pain, Myofascial

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)Does not accept healthy volunteers

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

Sites / Locations

  • Patricia Martínez Merinero

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group

Control group

Arm Description

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 technique in PG.The needle will be moved in-and-out into different directions to encounter sensitive spots in PG region.

Outcomes

Primary Outcome Measures

Pressure Pain Threshold (PPT)
An algometer Wagner FPI 10-WA will be used to determine the PPT in levator scapulae trigger points

Secondary Outcome Measures

Pain Visual Analogue Scale
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.
Strength in cervical latero-flexion
Dynamic dynamometry with MicroFet-2 will be used while patients will positioned in seated. From this position, patients will performed lateral - flexion

Full Information

First Posted
January 16, 2017
Last Updated
February 23, 2021
Sponsor
University of Alcala
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1. Study Identification

Unique Protocol Identification Number
NCT03025230
Brief Title
Dry Needling Versus Intramuscular Stimulation in the Management of the Myofascial Trigger Points
Official Title
Effectiveness of Dry Needling and Intramuscular Electrostimulation in the Treatment of Myofascial Trigger Points in Patients With Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alcala

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trigger Point Pain, Myofascial, Muscle Pain, Myofascial Pain Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Dry technique in PG.The needle will be moved in-and-out into different directions to encounter sensitive spots in PG region.
Intervention Type
Other
Intervention Name(s)
Dry needling and electric stimulation
Intervention Description
Dry needling technique and the application of electric stimulation of levator scapulae PG
Intervention Type
Other
Intervention Name(s)
Dry needling
Intervention Description
Treatment of PG with a filiform needle in levator scapulae muscle
Primary Outcome Measure Information:
Title
Pressure Pain Threshold (PPT)
Description
An algometer Wagner FPI 10-WA will be used to determine the PPT in levator scapulae trigger points
Time Frame
Change from baseline at one week
Secondary Outcome Measure Information:
Title
Pain Visual Analogue Scale
Description
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.
Time Frame
Change from baseline at one week
Title
Strength in cervical latero-flexion
Description
Dynamic dynamometry with MicroFet-2 will be used while patients will positioned in seated. From this position, patients will performed lateral - flexion
Time Frame
Change from baseline at one week

10. Eligibility

Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomás Gallego-Izquierdo, Doctor
Organizational Affiliation
Alcala University
Official's Role
Study Director
Facility Information:
Facility Name
Patricia Martínez Merinero
City
Alcala de Henares
State/Province
Madrid
ZIP/Postal Code
28806
Country
Spain

12. IPD Sharing Statement

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

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