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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

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

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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

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.




Primary Outcome Measures :
  1. 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).

  2. 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).

  3. 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 :
  1. 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
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

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.

Publications:

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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