- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04390438
Efficacy of High and Low Intensity Percutaneous Electrolysis for the Treatment of Myofascial Pain Syndrome
Efficacy of High and Low Intensity Percutaneous Electrolysis for the Treatment of Myofascial Pain Syndrome: A Pilot Study
Muscle pain is frequently attributed to myofascial pain syndrome (MPS) in which myofascial trigger points (MTrP) are a characteristic feature. Dry needling is a frequent clinical practice to manage MPS but few evidence is published about percutaneous electrolysis effects for the treatment of MPS.
This is a randomized clinical trial with 3 parallel groups: 1) High intensity-short time percutaneous electrolysis; 2) Low intensity-long time percutaneous electrolysis; 3) dry needling control group.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The current study aimed to evaluate changes in rectus femurs active trigger points and patellar tendon pain pressure thresholds and subjective anterior knee pain perception after application of two percutaneous electrolysis methods using a same charge (high intensity and low intensity) compared to a dry needling group in patients with patellofemoral pain syndrome (PFPS)
Fifteen patients diagnosed with unilateral PFPS were divided in two experimental groups (high intensity percutaneous electrolysis and low intensity percutaneous electrolysis) and one active control group (dry needling. The duration of the study was 7 days with only one intervention. Pain pressure thresholds were assessed using an algometer before the intervention, immediately after the intervention and after 7 days and a Visual Analogue Scale was used before the treatment and after 7 days to rate the subjective anterior knee pain perception. Also a VAS was used to rate the pain perception during the intervention
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Madrid
-
Villanueva de la Cañada, Madrid, Spain, 28692
- Camilo Jose Cela University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Athletes with knee pain
- Presence of at least one active Trigger point
Exclusion Criteria:
- Farmacologic treatment
- Surgery or traumas
- Skin alterations or infections
- Prior 6 weeks DN nor PT treatment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: High-Intensity short time percutaneous electrolysis
Application of a 0,66uA galvanic current in the active TrP through a needle during 10 seconds.
During the 20 seconds left necessary to blind the patient and the examiner, the needle was inside but with no electrical current
|
Needle emplacement with a galvanic electrical current
|
|
EXPERIMENTAL: Low-Intensity long time percutaneous electrolysis
Application of a 0,22uA galvanic current in the active TrP through a needle during 30 seconds
|
Needle emplacement with a galvanic electrical current
|
|
ACTIVE_COMPARATOR: Dry needling
One acupuncture needle was placed in the active TrP to produce a local twitch response during 30 seconds
|
Needle emplacement without electrical current nor substance
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pressure Pain Threshold (Trigger Point)
Time Frame: 7 days
|
Algometry (Wagner analogical algometer)
|
7 days
|
|
Pressure Pain Threshold (Patellar Tendon)
Time Frame: 7 days
|
Algometry (Wagner analogical algometer)
|
7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Subjective pain perception
Time Frame: 7 days
|
Visual Analogue Scale
|
7 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Juan Antonio Valera-Calero, PT, Msc, Camilo Jose Cela University
- Study Director: Alberto Sanchez-Mayoral-Martín, PT, Free professional practice
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 (ACTUAL)
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
- 50997093
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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