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
About this trial
This is an interventional treatment trial for Trigger Point Pain, Myofascial
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
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
NCT ID
NCT03025230
First Posted
January 16, 2017
Last Updated
February 23, 2021
Sponsor
University of Alcala
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
Learn more about this trial
Dry Needling Versus Intramuscular Stimulation in the Management of the Myofascial Trigger Points
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