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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:
Sponsor: University of Nove de Julho

Current Primary Outcome:

  • Pain Intensity Measure using Visual Analog Scale [ Time Frame: 5 minutes before procedure ]
    Self reported pain intensity following Visual Analog Scale, scored 0-10 (0=no pain; 10=the worst pain ever).
  • Pain Intensity Measure using the change in Visual Analog Scale from baseline at 1 month [ Time Frame: 5 minutes after procedure ]
    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).
  • Pain Intensity Measure using the Visual Analog Scale [ Time Frame: 1 month and 6 months after procedure ]
    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).


Original Primary Outcome:

  • Pain Intensity Measure using Visual Analog Scale [ Time Frame: 5 minutes before procedure ]
    Self reported pain intensity following Visual Analog Scale, scored 0-10 (0=no pain; 10=the worst pain ever).
  • Pain Intensity Measure using the change in Visual Analog Scale from baseline at 1 month [ Time Frame: 5 minutes after procedure ]
    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).
  • Pain Intensity Measure using the Visual Analog Scale [ Time Frame: 1 month after procedure ]
    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).


Current Secondary Outcome: Immunochemistry to analyse IL-1, IL-10, TNF alfa. [ Time Frame: Samples collected 1 minute after the application of laser, radiofrequency or lidocaine ]

Through the needle used the sample will be collected and examined by immunocytochemical staining and ELISA.


Original Secondary Outcome: Same as current

Information By: University of Nove de Julho

Dates:
Date Received: August 11, 2015
Date Started: March 2014
Date Completion: November 2016
Last Updated: March 14, 2016
Last Verified: March 2016