An interventional study of Laser and Drug: Lidocaine in Pain, Low Back Pain and Nociceptive Pain, sponsored by University of Nove de Julho. Completed at 1 site in Brazil. Open to participants aged 20 Years to 90 Years. Per ClinicalTrials.gov, last updated 2018-06-18.
Sponsored by University of Nove de Julho · Not applicable, Interventional, and Treatment
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.
2,450 studies on the registry are indexed under Pain; 945 are open to participants now.
This study's enrollment of 31 is below the median of 70 across 2,101 interventional studies indexed under Pain.
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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
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
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
Low level laser therapy will be delivered through Laser Photon III ® (DMC) in the second lumbar dorsal root ganglion.
1 mL of Lidocaine will be delivered in the second lumbar dorsal root ganglion through fluoroscopy.
Radiofrequency will be delivered during 300 seconds, 42oC in the second lumbar dorsal root ganglion.
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).
Time frame: 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).
Time frame: 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).
Time frame: 1 month and 6 months after procedure
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.
Time frame: Samples collected 1 minute after the application of laser, radiofrequency or lidocaine
This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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