- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03025230
Dry Needling Versus Intramuscular Stimulation in the Management of the Myofascial Trigger Points
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
Status
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Madrid
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Alcala de Henares, Madrid, Spain, 28806
- Patricia Martinez Merinero
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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.
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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.
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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
Sponsor
Investigators
- Study Director: Tomás Gallego-Izquierdo, Doctor, Alcala University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- M2012119/20130409
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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