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

Study Overview
=================
Brief Summary
-----------------
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.

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.

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

Conditions
-----------------
Chronic Low-back Pain

Intervention / Treatment
-----------------
* Other: Ultrasound-guided percutaneous electrolysis in the lumbar nerve root
* Other: Electrical Dry Needling in trigger points


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 67 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Percutaneous electrolysis in the lumbar nerv<br>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 / 3 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<br>* 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 / 3 weeks). The intervention will be guided by ultrasound equipment medically certified (Directive 93/42 / EEC) device (EPI Advanced Medicine, Barcelona, Spain).<br>|
| Active Comparator: Electrical dry needling in trigger points<br>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<br>* 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).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Algometry | 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 1 week after the last intervention, and 1-month follow-up period. | 
| Change from baseline in Roland Morris Disability Questionnaire (RMDQ). | 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 1 week after the last intervention, and 1-month follow-up period. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in disability. Oswestry Low Back Pain Disability Idex. | It has 10 items associated to activities of daily living, each item has a punctuation from 0 to 5 points. | At baseline, at 1 week after the last intervention, and 1-month follow-up period. | 
| Change from baseline in pain intensity. Visual analogue scale. | A 10-point Numerical Pain Scale (0: no pain, 10: maximum pain) assesses the intensity of pain | At baseline, at 1 week after the last intervention, and 1-month follow-up period. | 
| Change from baseline in Fear of Movement. Tampa Scale of kinesiophobia. | Is a 17-item questionnaire that measures the fear of movement and (re)injury. | At baseline, at 1 week after the last intervention, and 1-month follow-up period. | 
| Change from baseline on Quality of Life. SF-36 Health questionnaire. | SF-36 Health questionnaire scores range from 0 to 100% and indicate the self-perceived health-related quality of life. | At baseline, at 1 week after the last intervention, and 1-month follow-up period. | 
| Change from Mcquade Test. | It measures the isometric endurance of trunk flexion muscles. | At baseline, at 1 week after the last intervention, and 1-month follow-up period. | 
| Change from baseline in range of motion and lumbar segmental mobility | 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 1 week after the last intervention, and 1-month follow-up period. | 
| Change from baseline in Fingers-floor distance (cm) | The patient flexes the trunk forward from the standing position, and the distance from the fingers to the ground is measured. | At baseline, at 1 week after the last intervention, and 1-month follow-up period. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intratissue Percutaneous Electrolysis, Trigger points, Lumbar nerve root, Randomized clinical trial, Electrical dry needling