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Efficacy of High and Low Intensity Percutaneous Electrolysis for the Treatment of Myofascial Pain Syndrome

Primary Purpose

Knee Pain Chronic, Muscle Pain

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Percutaneous Electrolysis
Dry needling
Sponsored by
Universidad Francisco de Vitoria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Pain Chronic focused on measuring Patellofemoral pain syndrome, Electrolysis, Myofascial Pain Syndromes, Acupuncture

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Camilo Jose Cela University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

High-Intensity short time percutaneous electrolysis

Low-Intensity long time percutaneous electrolysis

Dry needling

Arm Description

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

Application of a 0,22uA galvanic current in the active TrP through a needle during 30 seconds

One acupuncture needle was placed in the active TrP to produce a local twitch response during 30 seconds

Outcomes

Primary Outcome Measures

Pressure Pain Threshold (Trigger Point)
Algometry (Wagner analogical algometer)
Pressure Pain Threshold (Patellar Tendon)
Algometry (Wagner analogical algometer)

Secondary Outcome Measures

Subjective pain perception
Visual Analogue Scale

Full Information

First Posted
April 30, 2020
Last Updated
May 13, 2020
Sponsor
Universidad Francisco de Vitoria
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1. Study Identification

Unique Protocol Identification Number
NCT04390438
Brief Title
Efficacy of High and Low Intensity Percutaneous Electrolysis for the Treatment of Myofascial Pain Syndrome
Official Title
Efficacy of High and Low Intensity Percutaneous Electrolysis for the Treatment of Myofascial Pain Syndrome: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
February 17, 2020 (Actual)
Primary Completion Date
March 30, 2020 (Actual)
Study Completion Date
April 27, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad Francisco de Vitoria

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
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Pain Chronic, Muscle Pain
Keywords
Patellofemoral pain syndrome, Electrolysis, Myofascial Pain Syndromes, Acupuncture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Clinical trial with 3 parallel groups; 2 experimental groups and 1 control group
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High-Intensity short time percutaneous electrolysis
Arm Type
Experimental
Arm Description
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
Arm Title
Low-Intensity long time percutaneous electrolysis
Arm Type
Experimental
Arm Description
Application of a 0,22uA galvanic current in the active TrP through a needle during 30 seconds
Arm Title
Dry needling
Arm Type
Active Comparator
Arm Description
One acupuncture needle was placed in the active TrP to produce a local twitch response during 30 seconds
Intervention Type
Procedure
Intervention Name(s)
Percutaneous Electrolysis
Intervention Description
Needle emplacement with a galvanic electrical current
Intervention Type
Procedure
Intervention Name(s)
Dry needling
Intervention Description
Needle emplacement without electrical current nor substance
Primary Outcome Measure Information:
Title
Pressure Pain Threshold (Trigger Point)
Description
Algometry (Wagner analogical algometer)
Time Frame
7 days
Title
Pressure Pain Threshold (Patellar Tendon)
Description
Algometry (Wagner analogical algometer)
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Subjective pain perception
Description
Visual Analogue Scale
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan Antonio Valera-Calero, PT, Msc
Organizational Affiliation
Camilo Jose Cela University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alberto Sanchez-Mayoral-Martín, PT
Organizational Affiliation
Free professional practice
Official's Role
Study Director
Facility Information:
Facility Name
Camilo Jose Cela University
City
Villanueva de la Cañada
State/Province
Madrid
ZIP/Postal Code
28692
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacy of High and Low Intensity Percutaneous Electrolysis for the Treatment of Myofascial Pain Syndrome

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