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

Sponsor

Universidad Francisco de Vitoria (Other)

Overall Status

Completed

CT.gov ID

NCT04390438

Collaborator

(none)

Enrollment

Location

Arms

2.3

Actual Duration (Months)

6.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Knee Pain Chronic Muscle Pain	Procedure: Percutaneous Electrolysis Procedure: Dry needling	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized Clinical trial with 3 parallel groups; 2 experimental groups and 1 control groupRandomized Clinical trial with 3 parallel groups; 2 experimental groups and 1 control group

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Efficacy of High and Low Intensity Percutaneous Electrolysis for the Treatment of Myofascial Pain Syndrome: A Pilot Study

Actual Study Start Date :

Feb 17, 2020

Actual Primary Completion Date :

Mar 30, 2020

Actual Study Completion Date :

Apr 27, 2020

Arms and Interventions

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	Procedure: Percutaneous Electrolysis 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	Procedure: Percutaneous Electrolysis 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	Procedure: Dry needling Needle emplacement without electrical current nor substance

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

Procedure: Percutaneous Electrolysis

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

Procedure: Percutaneous Electrolysis

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

Procedure: Dry needling

Needle emplacement without electrical current nor substance

Outcome Measures

Primary Outcome Measures

Pressure Pain Threshold (Trigger Point) [7 days]
Algometry (Wagner analogical algometer)
Pressure Pain Threshold (Patellar Tendon) [7 days]
Algometry (Wagner analogical algometer)

Secondary Outcome Measures

Subjective pain perception [7 days]
Visual Analogue Scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Camilo Jose Cela University	Villanueva de la Cañada	Madrid	Spain	28692

Sponsors and Collaborators

Universidad Francisco de Vitoria

Investigators

Principal Investigator: Juan Antonio Valera-Calero, PT, Msc, Camilo Jose Cela University
Study Director: Alberto Sanchez-Mayoral-Martín, PT, Free professional practice