Low Level Laser Therapy in the Dorsal Root Ganglion in the Treatment of Chronic Low Back Pain
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ClinicalTrials.gov Identifier: NCT02529670 |
Recruitment Status :
Completed
First Posted : August 20, 2015
Last Update Posted : June 18, 2018
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Condition or disease | Intervention/treatment | Phase |
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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 |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |

Arm | Intervention/treatment |
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Experimental: Laser
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.
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Procedure: Laser
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.
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Procedure: Radiofrequency
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.
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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.

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Ages Eligible for Study: | 20 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02529670
Brazil | |
Nove de Julho Universtiy | |
Sao Paulo, São Paulo, Brazil, 01321001 |
Responsible Party: | Vanessa Milanesi Holanda, MD, MS, University of Nove de Julho |
ClinicalTrials.gov Identifier: | NCT02529670 |
Other Study ID Numbers: |
53123716.3.0000.5511 |
First Posted: | August 20, 2015 Key Record Dates |
Last Update Posted: | June 18, 2018 |
Last Verified: | June 2018 |
Low Level Laser Therapy Low Back Pain Diagnosis Genetic Clinical trial |
Neuralgia Back Pain Low Back Pain Nociceptive Pain Pain Neurologic Manifestations Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases Lidocaine Anesthetics, Local |
Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents Anti-Arrhythmia Agents Voltage-Gated Sodium Channel Blockers Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action |