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Completed

NCT Number: NCT04290221

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

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.

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Key information

Conditions

Chronic Low-back Pain

Age range

30 year–67 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad de Almeria

Almería, Almeria, 04120, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ultrasound-guided percutaneous electrolysis in the lumbar nerve root

Other

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).

Electrical Dry Needling in trigger points

Other

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).

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

Sponsors and collaborators

Lead sponsor

Universidad de Almeria

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Feb 28, 2020
Registry last updated
Feb 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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