Effectiveness Analysis of Ultrasound-guided Intratissue Percutaneous Electrolysis (EPI) in Patient With Chronic Low Back Pain

February 2, 2025 updated by: Adelaida María Castro-Sánchez, Universidad de Almeria

Comparing Effectiveness Two Intratissue Percutaneous Electrolysis (EPI) Interventions for Chronic Low Back Pain: Lumbar Nerve Root Stimulation vs Trigger Points Stimulation

The main objective of this study is to analyze the effectiveness of the lumbar nerve root stimulation with ultrasound-guided percutaneous electrolysis versus the electrical dry needling of trigger points in patients with chronic low back pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Given that recently the effectiveness of intratissue percutaneous electrolysis (EPI) has become of interest in the treatment of chronic musculoskeletal pain, when conventional physiotherapy management is not successful, the EPI can promote the healing biological processes. Several studies have demonstrated that inflammation can play an important role in the progression of muscle degeneration, in addition to potentially contributing to painful symptoms in individuals with chronic low back pain.

This technique involves nonthermal, electrochemical ablation of the lesion via the use of a cathodic fluid. The inflammation provoked is very localized and healing is rapid. Although EPI has been widely employed lately, the literature contains few studies validating its use.

The good results reported in studies of tendinopathies have to the undertaking of the present work, which compares the long-term effectiveness of EPI and dry needling-both ultrasound-guided-for the treatment of chronic low back pain.

A double blind clinical trial will be developed in a sample of 80 subjects with chronic low back pain. Patients of experimental group will receive 1 weekly sessions of intratissue percutaneous electrolysis for 3 weeks, for a total of 3 sessions. The aim is to compare the effectiveness of applying percutaneous electrolysis in the lumbar nerve root versus applying electrical dry needling on trigger points of the gluteus medius, quadratus lumborum, and erector spinae muscles (6 sessions, once a week) on disability, pain, fear of movement, quality of life, resistance of the trunk flexors, lumbar mobility and muscular electrical activity.

Study Type

Interventional

Enrollment (Actual)

64

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

  • Spain
    • Almeria
      • Almería, Almeria, Spain, 04120
        • Universidad de Almería

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

30 years to 67 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Low back pain ≥ 3 months.
  • Age between 30 and 67 years old.
  • Score ≥ 4 points on the Roland Morris Disability Questionnaire.
  • Not being receiving other physical therapy.

Exclusion Criteria:

  • Presence of lumbar stenosis.
  • Diagnosis of spondylolisthesis.
  • Diagnosis of fibromyalgia.
  • Treatment with corticosteroids or oral medication in recent weeks.
  • History of spine surgery.
  • Contraindication of analgesic electrical therapy.
  • Have previously received a treatment of intratissue percutaneous electrolysis.
  • Central or peripheral nervous system disease.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Electrical dry needling in trigger points
It consists in apply the electrical dry needling on active and/or latent TPs in the gluteus medius, quadratus lumborum, and erector spinae muscles of the subjects L3 (one times per week / 6 weeks).
Other: Electrical Dry Needling in trigger points
It consists in apply the ultrasound-guided percutaneous electrolysis on active and/or latent TPs in the gluteus medius, quadratus lumborum, and erector spinae muscles of the subjects L3 (one times per week / 6 weeks).
Experimental: Percutaneous electrolysis in the lumbar nerv
This group will be treated with intratissue percutaneous electrolysis using a needle G32 with galvanic current as a cathodic flow electrode in the posterior nerve root of L3, L4 and L5, bilaterally (one times per week / 6 weeks). The intervention will be guided by ultrasound equipment medically certified (Directive 93/42 / EEC) device (EPI Advanced Medicine, Barcelona, Spain).
Other: Ultrasound-guided percutaneous electrolysis in the lumbar nerve root
This group will be treated with intratissue percutaneous electrolysis using a needle G32 with galvanic current as a cathodic flow electrode in the posterior nerve root of L3 (one times per week / 6 weeks). The intervention will be guided by ultrasound equipment medically certified (Directive 93/42 / EEC) device (EPI Advanced Medicine, Barcelona, Spain).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Algometry
Time Frame: At baseline, at 3 weeks, at 6 weeks, and 1 month after the last intervention.

An instrument for measuring the degree of sensitivity to pain. We will carry out a location of the myofascial trigger points following the illustrations of location of the myofascial trigger points that indicate Travell and Simons of both the left and right hemibody.

Once located they will be classified as active or latent. Measured in kg / cm 2 with an analog pressure algometer model Wagner FDK20. To carry out this diagnosis using the analog pressure algometer, a force of 1Kg / sec will be applied until the subject indicates with a "YA" presence of pain, at that time we will stop the pressure made with the analog pressure algometer and record the result. The measurement will be executed 3 times with a 30 sec rest between each measurement and an average of the 3 results obtained will be obtained.

Myofascial trigger points that do not meet the above criteria will be considered latent and which will not be subject to any treatment.
At baseline, at 3 weeks, at 6 weeks, and 1 month after the last intervention.
Change from baseline in Roland Morris Disability Questionnaire (RMDQ).
Time Frame: At baseline, at 3 weeks, at 6 weeks, and 1 month after the last intervention.
This is a self-reported questionnaire consisting in 24 items reflecting limitations in different activities of daily living attributed to low back pain including walking, vending over, sitting, lying down, dressing, sleeping, self-care and daily activities.
At baseline, at 3 weeks, at 6 weeks, and 1 month after the last intervention.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in disability. Oswestry Low Back Pain Disability Idex.
Time Frame: At baseline, at 3 weeks, at 6 weeks, and 1 month after the last intervention.
It has 10 items associated to activities of daily living, each item has a punctuation from 0 to 5 points.
At baseline, at 3 weeks, at 6 weeks, and 1 month after the last intervention.
Change from baseline in pain intensity. Visual analogue scale.
Time Frame: At baseline, at 3 weeks, at 6 weeks, and 1 month after the last intervention.
A 10-point Numerical Pain Scale (0: no pain, 10: maximum pain) assesses the intensity of pain
At baseline, at 3 weeks, at 6 weeks, and 1 month after the last intervention.
Change from baseline in Fear of Movement. Tampa Scale of kinesiophobia.
Time Frame: At baseline, at 3 weeks, at 6 weeks, and 1 month after the last intervention.
Is a 17-item questionnaire that measures the fear of movement and (re)injury.
At baseline, at 3 weeks, at 6 weeks, and 1 month after the last intervention.
Change from baseline on Quality of Life. SF-36 Health questionnaire.
Time Frame: At baseline, at 3 weeks, at 6 weeks, and 1 month after the last intervention.
SF-36 Health questionnaire scores range from 0 to 100% and indicate the self-perceived health-related quality of life.
At baseline, at 3 weeks, at 6 weeks, and 1 month after the last intervention.
Change from Mcquade Test.
Time Frame: At baseline, at 3 weeks, at 6 weeks, and 1 month after the last intervention.
It measures the isometric endurance of trunk flexion muscles.
At baseline, at 3 weeks, at 6 weeks, and 1 month after the last intervention.
Change from baseline in range of motion and lumbar segmental mobility
Time Frame: At baseline, at 3 weeks, at 6 weeks, and 1 month after the last intervention.
This variable is quantified using the SpinalMouse ® device (Phisiotech, Spain). It is an electronic computer-aided measuring device that measures sagittal spinal amplitude of movement (ROM) and intersegmental angles in a non-invasive way.
At baseline, at 3 weeks, at 6 weeks, and 1 month after the last intervention.
Change from baseline in Fingers-floor distance (cm)
Time Frame: At baseline, at 3 weeks, at 6 weeks, and 1 month after the last intervention.
The patient flexes the trunk forward from the standing position, and the distance from the fingers to the ground is measured.
At baseline, at 3 weeks, at 6 weeks, and 1 month after the last intervention.
Change from baseline in Quality of Sleep . Pittsburgh Quality of Sleep Questionnaire Index
Time Frame: At baseline, at 3 weeks, at 6 weeks, and 1 month after the last intervention.
The Pittsburgh Quality of Sleep Questionnaire Index (PSQI) will be used to study the quality of sleep. It comprises 24 items where the subjects respond to 19 of these items, and individual living in the same dwelling (or hospital room) responds to the remaining 5. Scores are obtained on each of 7 components of sleep quality: subjective quality, sleep latency, sleep duration, habitual sleep efficacy, sleep perturbations, use of hypnotic medication, and daily dysfunction.
At baseline, at 3 weeks, at 6 weeks, and 1 month after the last intervention.
Change from baseline in Anxiety. Hospital Anxiety and Depression Scale (HADS)
Time Frame: At baseline, at 3 weeks, at 6 weeks, and 1 month after the last intervention.
The HADS is a 14-question instrument that measures anxiety and depression. Each question is scored between 0 (no impairment) and 3 (severe impairment), with a maximum score of 21 for anxiety or depression.
At baseline, at 3 weeks, at 6 weeks, and 1 month after the last intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Almeria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

November 30, 2021

Primary Completion (Actual)

March 4, 2022

Study Completion (Actual)

June 4, 2023

Study Registration Dates

First Submitted

February 26, 2020

First Submitted That Met QC Criteria

February 27, 2020

First Posted (Actual)

February 28, 2020

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 2, 2025

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UALBIO2019/037

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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