Back to resultsPercutaneous Electrolysis Versus Dry Needling in Levator Scapulae
Primary Purpose
Trigger Point Pain, Myofascial, Myofascial Pain
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Percutaneous electrolysis
Dry needling
Sponsored by
About this trial
This is an interventional treatment trial for Trigger Point Pain, Myofascial
Eligibility Criteria
Inclusion Criteria:
- Neck pain
- At least two active myofascial trigger point in the levator scapulae muscle
Exclusion Criteria:
- Systemic diseases
- Cognitive impairment
Sites / Locations
- Fisiofuenla SLP
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ultrasound-guided percutaneous electrolysis
ultrasound-guided dry needling
Arm Description
Outcomes
Primary Outcome Measures
Pain intensity
Neck pain intensity scores from 0 to 100 points measured by the visual analogue scale
Secondary Outcome Measures
Disability
Neck disability scores measured from 0 to 50 points measured by the Neck Disability Index
Range of motion
Neck rotation range of motion measured with an universal goniometer
Full Information
NCT ID
NCT04157426
First Posted
November 6, 2019
Last Updated
December 31, 2021
Sponsor
Universidad Complutense de Madrid
1. Study Identification
Unique Protocol Identification Number
NCT04157426
Brief Title
Percutaneous Electrolysis Versus Dry Needling in Levator Scapulae
Official Title
Effectiveness of Ultrasound-guided Interventions of Percutaneous Electrolysis Versus Dry Needling in Levator Scapulae Active Myofascial Trigger Points
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
September 28, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
January 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Complutense de Madrid
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trigger Point Pain, Myofascial, Myofascial Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ultrasound-guided percutaneous electrolysis
Arm Type
Experimental
Arm Title
ultrasound-guided dry needling
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Percutaneous electrolysis
Intervention Description
Ultrasound-guided percutaneous electrolysis in the active myofascial trigger point of the levator scapulae muscle
Intervention Type
Other
Intervention Name(s)
Dry needling
Intervention Description
Ultrasound-guided dry needling the active myofascial trigger point of the levator scapulae muscle
Primary Outcome Measure Information:
Title
Pain intensity
Description
Neck pain intensity scores from 0 to 100 points measured by the visual analogue scale
Time Frame
Change from baseline pain intensity immediately and at 1 week after intervention
Secondary Outcome Measure Information:
Title
Disability
Description
Neck disability scores measured from 0 to 50 points measured by the Neck Disability Index
Time Frame
Change from baseline pain intensity at 1 week after intervention
Title
Range of motion
Description
Neck rotation range of motion measured with an universal goniometer
Time Frame
Change from baseline pain intensity immediately and at 1 week after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Neck pain
At least two active myofascial trigger point in the levator scapulae muscle
Exclusion Criteria:
Systemic diseases
Cognitive impairment
Facility Information:
Facility Name
Fisiofuenla SLP
City
Fuenlabrada
State/Province
Madrid
ZIP/Postal Code
28040
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
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Percutaneous Electrolysis Versus Dry Needling in Levator Scapulae
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