Low Level Laser Therapy in the Dorsal Root Ganglion in the Treatment of Chronic Low Back Pain
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02529670|
Recruitment Status : Completed
First Posted : August 20, 2015
Last Update Posted : June 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pain Low Back Pain Nociceptive Pain Neuropathic Pain Low Level Laser Therapy||Procedure: Laser Procedure: Drug: Lidocaine Procedure: Radiofrequency||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|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|
|Study Start Date :||March 2014|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||December 2016|
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.
Low level laser therapy will be delivered through Laser Photon III ® (DMC) in the second lumbar dorsal root ganglion.
Active Comparator: Radiofrequency
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.
Radiofrequency will be delivered during 300 seconds, 42oC in the second lumbar dorsal root ganglion.
Active Comparator: Drug: Lidocaine
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
1 mL of Lidocaine will be delivered in the second lumbar dorsal root ganglion through fluoroscopy.
- 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).
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02529670
|Nove de Julho Universtiy|
|Sao Paulo, São Paulo, Brazil, 01321001|