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

Sponsor:

Collaborator:

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Information provided by (Responsible Party):

Vanessa Milanesi Holanda, University of Nove de Julho

Study Description

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.

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 Design

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Drug Information available for: Lidocaine

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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.	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.	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.	Procedure: Drug: Lidocaine 1 mL of Lidocaine will be delivered in the second lumbar dorsal root ganglion through fluoroscopy.

Outcome Measures

Primary Outcome Measures :

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).

Secondary Outcome Measures :

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.

Eligibility Criteria

Information from the National Library of Medicine

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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

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

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

Locations

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Brazil
Nove de Julho Universtiy
Sao Paulo, São Paulo, Brazil, 01321001

Sponsors and Collaborators

University of Nove de Julho

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

More Information

Publications:

Rydevik BL, Myers RR, Powell HC. Pressure increase in the dorsal root ganglion following mechanical compression. Closed compartment syndrome in nerve roots. Spine (Phila Pa 1976). 1989 Jun;14(6):574-6.

Hart LG, Deyo RA, Cherkin DC. Physician office visits for low back pain. Frequency, clinical evaluation, and treatment patterns from a U.S. national survey. Spine (Phila Pa 1976). 1995 Jan 1;20(1):11-9.

Deyo RA, Mirza SK, Martin BI. Back pain prevalence and visit rates: estimates from U.S. national surveys, 2002. Spine (Phila Pa 1976). 2006 Nov 1;31(23):2724-7.

Breivik H, Collett B, Ventafridda V, Cohen R, Gallacher D. Survey of chronic pain in Europe: prevalence, impact on daily life, and treatment. Eur J Pain. 2006 May;10(4):287-333. Epub 2005 Aug 10.

Frymoyer JW, Cats-Baril WL. An overview of the incidences and costs of low back pain. Orthop Clin North Am. 1991 Apr;22(2):263-71. Review.

Katz JA. Getting the lowdown on back pain. Nursing. 2001 Dec;31(12):24.

Schaeffer V, Meyer L, Patte-Mensah C, Mensah-Nyagan AG. Progress in dorsal root ganglion neurosteroidogenic activity: basic evidence and pathophysiological correlation. Prog Neurobiol. 2010 Sep;92(1):33-41. doi: 10.1016/j.pneurobio.2010.04.009. Epub 2010 May 10. Review.

de Souza Grava AL, Ferrari LF, Defino HL. Cytokine inhibition and time-related influence of inflammatory stimuli on the hyperalgesia induced by the nucleus pulposus. Eur Spine J. 2012 Mar;21(3):537-45. doi: 10.1007/s00586-011-2027-8. Epub 2011 Sep 25.

Chow R, Yan W, Armati P. Electrophysiological effects of single point transcutaneous 650 and 808 nm laser irradiation of rat sciatic nerve: a study of relevance for low-level laser therapy and laser acupuncture. Photomed Laser Surg. 2012 Sep;30(9):530-5. doi: 10.1089/pho.2012.3248. Epub 2012 Jul 10.

Lauria G, Bakkers M, Schmitz C, Lombardi R, Penza P, Devigili G, Smith AG, Hsieh ST, Mellgren SI, Umapathi T, Ziegler D, Faber CG, Merkies IS. Intraepidermal nerve fiber density at the distal leg: a worldwide normative reference study. J Peripher Nerv Syst. 2010 Sep;15(3):202-7. doi: 10.1111/j.1529-8027.2010.00271.x.

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Responsible Party:	Vanessa Milanesi Holanda, MD, MS, University of Nove de Julho
ClinicalTrials.gov Identifier:	NCT02529670 History of Changes
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

Keywords provided by Vanessa Milanesi Holanda, University of Nove de Julho:


Low Level Laser Therapy Low Back Pain Diagnosis Genetic Clinical trial

Additional relevant MeSH terms:

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Neuralgia Back Pain Low Back Pain Nociceptive Pain Pain Neurologic Manifestations Signs and Symptoms 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

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