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

NCT02529670 | Completed DMC

• 1 other identifier: 53123716.3.0000.5511
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Low Back Pain; Nociceptive Pain; Neuropathic Pain; Low Level Laser Therapy

Keywords

Low Level Laser Therapy; Low Back Pain; Diagnosis; Genetic; Clinical trial

Outcome Measures

Primary Outcomes (3)

• 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).

  5 minutes before procedure

• 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).

  5 minutes after procedure

• 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).

  1 month and 6 months after procedure

Secondary Outcomes (1)

• Immunochemistry to analyse IL-1, IL-10, TNF alfa.

  Samples collected 1 minute after the application of laser, radiofrequency or lidocaine

Study Arms (3)

Laser

EXPERIMENTAL

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

Radiofrequency

ACTIVE COMPARATOR

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

Drug: Lidocaine

ACTIVE COMPARATOR

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

Interventions

Laser PROCEDURE

Low level laser therapy will be delivered through Laser Photon III ® (DMC) in the second lumbar dorsal root ganglion.

Laser

Drug: Lidocaine PROCEDURE

1 mL of Lidocaine will be delivered in the second lumbar dorsal root ganglion through fluoroscopy.

Drug: Lidocaine

Radiofrequency PROCEDURE

Radiofrequency will be delivered during 300 seconds, 42oC in the second lumbar dorsal root ganglion.

Radiofrequency

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic low back pain (more than 3 months of nociceptive or neuropathic pain).
• No neurological deficits

You may not qualify if:

• Active lumbar cancer
• Active infection
• Coagulation disorders

Sponsors & Collaborators

• University of Nove de Julho: lead
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator

Study Sites (1)

Nove de Julho Universtiy

São Paulo, São Paulo, 01321001, Brazil

Location

Related Publications (10)

• 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. doi: 10.1097/00007632-198906000-00004.

  PMID: 2749371 BACKGROUND

• 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.

  PMID: 7709270 BACKGROUND

• 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.

  PMID: 17077742 BACKGROUND

• 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.

  PMID: 16095934 BACKGROUND

• 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.

  PMID: 1826550 BACKGROUND

• Katz JA. Getting the lowdown on back pain. Nursing. 2001 Dec;31(12):24. doi: 10.1097/00152193-200131120-00008. No abstract available.

  PMID: 11921711 BACKGROUND

• 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.

  PMID: 20438798 BACKGROUND

• 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.

  PMID: 21947908 BACKGROUND

• 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.

  PMID: 22779441 BACKGROUND

• 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.

  PMID: 21040142 BACKGROUND

MeSH Terms

Conditions

Pain; Low Back Pain; Nociceptive Pain; Neuralgia; Disease

Interventions

Lasers; Lidocaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Back Pain; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pathologic Processes

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MS

Study Record Dates

• First Submitted: August 11, 2015
• First Posted: August 20, 2015
• Study Start: March 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: December 1, 2016
• Last Updated: June 18, 2018

Record last verified: 2018-06

Locations

BR (1)