- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04157426
Percutaneous Electrolysis Versus Dry Needling in Levator Scapulae
December 31, 2021 updated by: César Calvo Lobo, Universidad Complutense de Madrid
Effectiveness of Ultrasound-guided Interventions of Percutaneous Electrolysis Versus Dry Needling in Levator Scapulae Active Myofascial Trigger Points
The objective will be to determine the effectiveness of ultrasound-guided percutaneous electrolysis versus ultrasound-guided dry needling in active myofascial trigger points of the levator scapulae muscle on pain intensity, disability and range of motion.
A randomized clinical trial will be carried out.
Fifty-four patients with at least one active myofascial trigger point in the levator scapulae muscle were recruited and divided into ultrasound-guided percutaneous electrolysis (n = 27) and ultrasound-guided dry needling (n=27).
Pain intensity, disability and range of motion will measured before, immediately after and 1 week after intervention.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
54
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
-
Fuenlabrada, Madrid, Spain, 28040
- Fisiofuenla SLP
-
-
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
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Neck pain
- At least two active myofascial trigger point in the levator scapulae muscle
Exclusion Criteria:
- Systemic diseases
- Cognitive impairment
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: Ultrasound-guided percutaneous electrolysis
|
Ultrasound-guided percutaneous electrolysis in the active myofascial trigger point of the levator scapulae muscle
|
Active Comparator: ultrasound-guided dry needling
|
Ultrasound-guided dry needling the active myofascial trigger point of the levator scapulae muscle
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain intensity
Time Frame: Change from baseline pain intensity immediately and at 1 week after intervention
|
Neck pain intensity scores from 0 to 100 points measured by the visual analogue scale
|
Change from baseline pain intensity immediately and at 1 week after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disability
Time Frame: Change from baseline pain intensity at 1 week after intervention
|
Neck disability scores measured from 0 to 50 points measured by the Neck Disability Index
|
Change from baseline pain intensity at 1 week after intervention
|
Range of motion
Time Frame: Change from baseline pain intensity immediately and at 1 week after intervention
|
Neck rotation range of motion measured with an universal goniometer
|
Change from baseline pain intensity immediately and at 1 week after intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
September 28, 2021
Primary Completion (Actual)
December 31, 2021
Study Completion (Actual)
January 1, 2022
Study Registration Dates
First Submitted
November 6, 2019
First Submitted That Met QC Criteria
November 6, 2019
First Posted (Actual)
November 8, 2019
Study Record Updates
Last Update Posted (Actual)
January 14, 2022
Last Update Submitted That Met QC Criteria
December 31, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PE_vs_DN
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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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