Effectiveness of Ecoguided Percutaneous Neuromodulation of the Multipurpose Musculature of L-3 in Non-specific Chronic Lumbar Pain.

Study Overview
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Brief Summary
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The study evaluates the effectiveness of Ultrasound-guided Percutaneous Neuromodulation in the lumbar multifidus of L3 in non-specific chronic low back pain.

Detailed Description
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The effectiveness of neuromoduation in analgesic therapies has been more than contrasted. Considering that multifidus muscles, composed of the spinous transverse rotators muscles and spinous transverse multifidus muscles, are fundamental both for the static and for the dynamics of the lumbar spine, particularly for the region of L-3, the treatment of this musculature with ultrasound-guided percutaneous neuromodulation in patients with nonspecific chronic low back pain must have an analgesic repercussion in this nociceptive process. Therefore, given that neuromodulation has been considered as a more than effective treatment in painful symptomatology and that diverse scientific literature has proven the activity of the multifida musculature directly affects the stability and mobility of the lumbar spine, it is more than likely interventions with neuromodulative treatments in the multifidus musculature at the level of the third lumbar vertebrae have positive results in Non-specific Chronic Low Back Pain.

Official Title
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Effectiveness of the Ecoguided Percutaneous Neuromodulation of the Multipurpose Musculature of L-3 in Non-specific Chronic Lumbar Pain.

Conditions
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Low Back Pain

Intervention / Treatment
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* Other: Ultrasound- guided Percutaneous Neuromulation
* Other: TENS Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Score ≥4 on the Roland Morris Disability Questionnaire. Low back pain for ≥3 months Age between 18 and 65 years Not undergoing another physical therapy treatment Exclusion Criteria: Presence of lumbar stenosis Diagnosis of spondylolisthesis Diagnosis of fibromyalgia Treatment with corticosteroid or oral medication within the past two weeks A history of spinal surgery Contraindication of analgesic electrical therapy Having previously received a treatment of electrical analgesia.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrasound-guided Percutaneous Neuromodulation<br>This group will be treated with percutaneous neuromodulation using a needle with Physio Invasive® device, in its modality of percutaneous electrostimulation for 15 minutes, and guided by ultrasound equipment in the multifidus muscles of L3 (1 times/ 4 weeks). | Other: Ultrasound- guided Percutaneous Neuromulation<br>* The experimental group will be treated with percutaneous neuromodulation using a needle with Physio Invasive® device, in its modality of percutaneous electrostimulation for 15 minutes, and guided by ultrasound equipment in the multifidus muscles of L-3, once a week for 4 weeks.<br>|
| Active Comparator: TENS therapy<br>The control group will apply a transcutaneous treatment with surface electrodes with TENS current at 170 Hz for 15 minutes in the L-3 region (1 times/ 4 weeks). | Other: TENS Therapy<br>* The control group will apply a transcutaneous treatment with surface electrodes with TENS current at 170 Hz for 15 minutes in the L-3 region, once a week for 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Roland Morris Disability Questionnaire (RMDQ) | This is a self-reported questionnaire consisting in 24 ítems 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 and at 4 weeks (immediate post-treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in disability. Oswestry Low Back Pain Disability Index (ODI). | It has 10 items associated to activities of daily living, each item has a puntuation fron 0 to 5 points. | At baseline and at 4 weeks (immediate post-treatment) | 
| 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 and at 4 weeks (immediate post-treatment) | 
| Change from baseline in Fear of Movement. Tampa Scale of kinesiophobia. | It is a 17-item questionnaire that measures the fear of movement and (re)injury | At baseline and at 4 weeks (immediate post-treatment) | 
| Change from baseline on Quality of Life. | SF-36 Health questionnaire scores range from 0 to 100% and indicate the self-perceived health-related quality of life. | At baseline and at 4 weeks (immediate post-treatment) | 
| Change from Mcquade Test | It measures the isometric endurance of trunk flexion muscles | At baseline and at 4 weeks (immediate post-treatment) | 
| Change from baseline in lumbar mobility flexion | It is determined by measuring the finger-to-floor distance | At baseline and at 4 weeks (immediate post-treatment) | 
| 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 sagital spinal amplitude of movement (ROM) and intersegmental angles in a non-invasive way. | At baseline and at 4 weeks (immediate post-treatment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TENS, Neuromodulation, Low back pain, Ultrasound-guied percutaneous, Randomized Controlled Trial, Percutaneous stimulation