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

Primary Purpose

Pain, Low Back Pain, Nociceptive Pain

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Laser
Drug: Lidocaine
Radiofrequency
Sponsored by
University of Nove de Julho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring Low Level Laser Therapy, Low Back Pain, Diagnosis, Genetic, Clinical trial

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nove de Julho Universtiy

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Laser

Radiofrequency

Drug: Lidocaine

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Pain Intensity Measure using Visual Analog Scale
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
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
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.
Through the needle used the sample will be collected and examined by immunocytochemical staining and ELISA.

Full Information

First Posted
August 11, 2015
Last Updated
June 14, 2018
Sponsor
University of Nove de Julho
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
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1. Study Identification

Unique Protocol Identification Number
NCT02529670
Brief Title
Low Level Laser Therapy in the Dorsal Root Ganglion in the Treatment of Chronic Low Back Pain
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 Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nove de Julho
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Low Back Pain, Nociceptive Pain, Neuropathic Pain, Low Level Laser Therapy
Keywords
Low Level Laser Therapy, Low Back Pain, Diagnosis, Genetic, Clinical trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laser
Arm Type
Experimental
Arm Description
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.
Arm Title
Radiofrequency
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Drug: Lidocaine
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Laser
Intervention Description
Low level laser therapy will be delivered through Laser Photon III ® (DMC) in the second lumbar dorsal root ganglion.
Intervention Type
Procedure
Intervention Name(s)
Drug: Lidocaine
Intervention Description
1 mL of Lidocaine will be delivered in the second lumbar dorsal root ganglion through fluoroscopy.
Intervention Type
Procedure
Intervention Name(s)
Radiofrequency
Intervention Description
Radiofrequency will be delivered during 300 seconds, 42oC in the second lumbar dorsal root ganglion.
Primary Outcome Measure Information:
Title
Pain Intensity Measure using Visual Analog Scale
Description
Self reported pain intensity following Visual Analog Scale, scored 0-10 (0=no pain; 10=the worst pain ever).
Time Frame
5 minutes before procedure
Title
Pain Intensity Measure using the change in Visual Analog Scale from baseline at 1 month
Description
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).
Time Frame
5 minutes after procedure
Title
Pain Intensity Measure using the Visual Analog Scale
Description
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).
Time Frame
1 month and 6 months after procedure
Secondary Outcome Measure Information:
Title
Immunochemistry to analyse IL-1, IL-10, TNF alfa.
Description
Through the needle used the sample will be collected and examined by immunocytochemical staining and ELISA.
Time Frame
Samples collected 1 minute after the application of laser, radiofrequency or lidocaine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Nove de Julho Universtiy
City
Sao Paulo
State/Province
São Paulo
ZIP/Postal Code
01321001
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
2749371
Citation
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Results Reference
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PubMed Identifier
7709270
Citation
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. doi: 10.1097/00007632-199501000-00003.
Results Reference
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PubMed Identifier
17077742
Citation
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. doi: 10.1097/01.brs.0000244618.06877.cd.
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PubMed Identifier
16095934
Citation
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. doi: 10.1016/j.ejpain.2005.06.009. Epub 2005 Aug 10.
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PubMed Identifier
1826550
Citation
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.
Results Reference
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PubMed Identifier
11921711
Citation
Katz JA. Getting the lowdown on back pain. Nursing. 2001 Dec;31(12):24. doi: 10.1097/00152193-200131120-00008. No abstract available.
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PubMed Identifier
20438798
Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
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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.
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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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