Low Level Laser Therapy in the Dorsal Root Ganglion in the Treatment of Chronic Low Back Pain

Study Overview
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Brief Summary
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Chronic axial low back pain is a public health problem and has a high socioeconomic impact. The dorsal ganglion of the second spinal nerve (GDL2) is a cluster of neuronal bodies responsible for sensory afferent inputs from more than 80% of the lumbar region. Low-level laser therapy (LLLT) is proven effective to help relieve pain. Thus, the aim of this project is to determine the effect of LLLT on GDL2 when applied to assist in the diagnosis and treatment of chronic axial low back pain. Methodology: 45 patients will be randomized into three groups: laser, radiofrequency and local anesthetic. The patient will be positioned in a prone horizontal position under anesthetic monitoring. The intervertebral foramen between the second and third lumbar vertebrae will be accessed by percutaneous puncture guided by fluoroscopy. In the local anesthetic group, injection of 1 ml lidocaine without vasoconstrictor will be applied in the tubes G20, 150 mm long and 5 mm active tip in contact with the target. In the radiofrequency group, neuromodulation will be held for 300 seconds at 42oC. In the laser group, the laser Photon III® (DCM) will be applied through optic fiber crossing G18 cannulas, during 84 seconds. The pain score will be assessed by visual analog scale. Temperature will be measured and aspirate periganglionic sample, trans-operatively, to study Interleucins-1β and TNF-alpha assessed by ELISA and genetic evaluation trough RNA seek, RNA isolation and ATP quantification. The data will be evaluated for normality and subjected to appropriate statistical analysis, in order to seek representation, as same as the level of significance of the studied samples.

Official Title
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Study of the Effect of Low Level Laser Therapy in the Dorsal Root Ganglion in the Diagnosis and Treatment of Chronic Low Back Pain

Conditions
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Pain, Low Back Pain, Nociceptive Pain, Neuropathic Pain, Low Level Laser Therapy

Intervention / Treatment
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* Procedure: Laser
* Procedure: Drug: Lidocaine
* Procedure: Radiofrequency


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic low back pain (more than 3 months of nociceptive or neuropathic pain). No neurological deficits Exclusion Criteria: Active lumbar cancer Active infection Coagulation disorders

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 90 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laser<br>15 patients will be positioned in a prone horizontal position under anesthetic monitoring. The intervertebral foramen between the second and third lumbar vertebrae will be accessed by percutaneous puncture guided by fluoroscopy. Laser Photon III® (DCM) will be applied through fiber optics crossing G18 cannulas, during 84 seconds. | Procedure: Laser<br>* Low level laser therapy will be delivered through Laser Photon III ® (DMC) in the second lumbar dorsal root ganglion.<br>|
| Active Comparator: Radiofrequency<br>15 patients will receive radiofrequency in the second dorsal root ganglion through tubes G20, 150 mm long and 5 mm active tip in contact with the target, neuromodulation will be held for 300 seconds at 42oC. | Procedure: Radiofrequency<br>* Radiofrequency will be delivered during 300 seconds, 42oC in the second lumbar dorsal root ganglion.<br>|
| Active Comparator: Drug: Lidocaine<br>In the local anesthetic group, 15 patients will receive the injection of 1 ml lidocaine without vasoconstrictor will be applied in the tubes G18, 150 mm long to block the second dorsal root ganglion. | Procedure: Drug: Lidocaine<br>* 1 mL of Lidocaine will be delivered in the second lumbar dorsal root ganglion through fluoroscopy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Intensity Measure using Visual Analog Scale | Self reported pain intensity following Visual Analog Scale, scored 0-10 (0=no pain; 10=the worst pain ever). | 5 minutes before procedure | 
| Pain Intensity Measure using the change in Visual Analog Scale from baseline at 1 month | Patients will report the intensity of the pain using the score in visual analogue scale, scored 0-10 (0=no pain; 10=the worst pain ever). | 5 minutes after procedure | 
| Pain Intensity Measure using the Visual Analog Scale | In follow up, patients will report the intensity of the pain using the score in visual analogue scale, scored 0-10 (0=no pain; 10=the worst pain ever). | 1 month and 6 months after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunochemistry to analyse IL-1, IL-10, TNF alfa. | Through the needle used the sample will be collected and examined by immunocytochemical staining and ELISA. | Samples collected 1 minute after the application of laser, radiofrequency or lidocaine | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low Level Laser Therapy, Low Back Pain, Diagnosis, Genetic, Clinical trial