Efficacy of Electrical Dry Needling in Pain, Sensitivity, Functionality and Quality of Life of Patients With Chronic Non-specific Low Back Pain

Study Overview
=================
Brief Summary
-----------------
The main objective of this study is to determine the efficacy of electrical dry needling versus ischemic compression, analytical stretching and postural habits educational dossier in active myofascial trigger points in patients with chronic non-specific low back pain.

Detailed Description
-----------------
A double-blind clinical trial will be developed in a sample of 80 subjects with chronic low back pain. Patients in the experimental group will receive electrical dry needling at the active myofascial trigger points (PGM) of the quadratus lumbar, multifidus, and iliocostal muscles (following the PGM maps described by Travell and Simons). The technique will be performed using needle electrodes, the generated current will be produced by a TENS device with a frequency of 2 Hz and a pulse width of 250 μs, during 30 min of application. The therapeutic intervention will be 1 weekly session for a total of 6 weeks. The control group will perform an ischemic compression technique in active PGM with a time between 20 seconds and 1 minute until pain inhibition is achieved, and finally, analytical stretching will be carried out on the quadratus lumbar, multifidus and iliocostal muscles. The treatment will consist of 1 weekly session for 6 weeks, in addition they will be provided with a training dossier on postural education in their activities of daily life. A baseline assessment of the primary and secondary outcome measures will be carried out before randomization of the participants to the different groups, an immediate post-treatment assessment (1 day after the last intervention) and an assessment two month after the end of the intervention ( short-term follow-up). The objectives of this study are to compare the repercussions of dry electropuncture versus ischemic compression in active PGM plus stretching in terms of pain, functionality, mobility of the spine, and quality of life in patients with non-specific chronic low back pain; and analyze the impact on active myofascial trigger points in terms of pressure tolerance threshold.

Official Title
-----------------
Comparison of the Efficacy of Electrical Dry Needling Versus Traditional Physical Therapy in the Treatment of Active Myofascial Trigger Points in Pain, Sensitivity, Functionality and Quality of Life of Patients With Chronic Non-specific Low Back Pain

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

Intervention / Treatment
-----------------
* Other: Electrical dry needling
* Other: Ischemic compression, analytical stretching and postural habits educational dossier


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Low back pain ≥ 3 months. Age between 30 and 67 years old. Not being receiving 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 electrical analgesia or exercise. 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: Electrical dry needling<br>The experimental group consisting of 40 subjects will perform electrostimulation on the active myofascial trigger points of the following muscles: quadratus lumbar, multifidus and iliocostalis, following the PGM maps described by Travell and Simons. The electrostimulation of the PGM will be carried out using needle electrodes, the generated current will be produced by a TENS device with a frequency of 2 Hz and a pulse width of 250 μs, the application will be approximately 30 min. The therapeutic intervention will be 1 session per week for a total of 6 weeks. | Other: Ischemic compression, analytical stretching and postural habits educational dossier<br>* The control group G2, formed by 40 subjects, will perform an ischemic compression technique in active PGM with a time between 20 seconds and 1 minute until pain inhibition is achieved, and finally, analytical stretching will be carried out on the quadratus lumbar, multifidus and iliocostal muscles, 1 weekly session for 6 weeks, in addition to providing them with a training dossier on postural education in their activities of daily life.<br>|
| Active Comparator: Ischemic compression, analytical stretching and postural habits educational dossier<br>The control group consisting of 40 subjects will undergo an ischemic compression technique in active PGM with a time between 20 seconds and 1 minute until pain inhibition is achieved, and finally, analytical stretching will be carried out on the quadratus lumbar, multifid and iliocostal, 1 weekly session for 6 weeks providing a training dossier of postural education in their activities of daily life. | Other: Electrical dry needling<br>* The experimental group consisting of 40 subjects will perform electrostimulation on the active myofascial trigger points of the following muscles: quadratus lumbar, multifidus and iliocostalis. The electrostimulation of the PGM will be carried out using needle electrodes, the generated current will be produced by a TENS device with a frequency of 2 Hz and a pulse width of 250 μs, the application will be approximately 30 min. The therapeutic intervention will be 1 session per week for a total of 6 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in pressure pain threshold by Wagner manual pressure algometer. | Apply the tip of the algometer perpendicular to the muscle and maintain a pressure, which will gradually increase to 1 kg / sec. Subjects will be instructed to signal the moment they experience pain, in order to have an accurate record (pain threshold). | At baseline, at 6 weeks and at 2 months | 
| 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.Ranging from 0 points- better to 24 points- worse disability | At baseline, at 6 weeks and at 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baselina in range of motion | 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 6 weeks and at 2 months | 
| Change from baseline in lumbar mobility flexion. | For the quantification of lumbar flexion an angular inclinometer is used (Fleximeter UM 8320-3 RJ Code Research Institute, Brazil). | At baseline, at 6 weeks and at 2 months | 
| Changes in pressure pain threshold by Wagner manual pressure algometer. | Apply the tip of the algometer perpendicular to the muscle and maintain a pressure, which will gradually increase to 1 kg / sec. Subjects will be instructed to signal the moment they experience pain, in order to have an accurate record (pain threshold). | At baseline, at 6 weeks and at 2 months | 
| Tampa Scale of Kinesiophobia (TSK).Change from baseline in Fear of Movement. | Is a 17-item questionnaire that measures the fear of movement and (re)injury.Patient rate beliefs about their pain on a 4-point scale ranging from strongly disagree to strongly agree (ranging from 17-68 points). | At baseline, at 6 weeks and at 2 months | 
| SF-36 Health Questionnaire (SF-36).Change from baseline on Quality of Life. | The SF-36 quality of life questionnaire assesses 8 domains including physical functioning, physical role, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. This scale ranges from 0 (lowest level of functioning) to 100 (highest level) | At baseline, at 6 weeks and at 2 months | 
| Change from Mcquade Test. | It measures the isometric endurance of trunk flexion muscles. | At baseline, at 6 weeks and at 2 months | 
| Change from insomnia Severity Index Índice de calidad de sueño de Pittsburgh. | This questionnaire consists of 24 questions. The total score can range from 0 to 21 points. The higher the total score, the worse the quality of sleep. | At baseline, at 6 weeks and at 2 months | 
| Change from baseline in disability. Oswestry Low Back Pain Disability Idex. | It has 10 items associated to activities of daily living, each ítem has a puntuation fron 0 to 5 points.The higher scores mean a worse outcome. | At baseline, at 6 weeks and at 2 months | 
| 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. Range from no pain 0 to maximum pain 10 points | At baseline, at 6 weeks and at 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Electrical dry needling, low back pain, Randomized clinical trial, ischemic compression, analytical stretch