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

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02529670
• Other study ID #: 53123716.3.0000.5511
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: December 2016

Study information

• Verified date: June 2018
• Source: University of Nove de Julho
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: December 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Low Level Laser Therapy
• Neuralgia
• Neuropathic Pain
• Nociceptive Pain
• Pain

Intervention

Procedure:
• Laser
Low level laser therapy will be delivered through Laser Photon III ® (DMC) in the second lumbar dorsal root ganglion.
• Drug: Lidocaine
1 mL of Lidocaine will be delivered in the second lumbar dorsal root ganglion through fluoroscopy.
• Radiofrequency
Radiofrequency will be delivered during 300 seconds, 42oC in the second lumbar dorsal root ganglion.

Locations

Country	Name	City	State
Brazil	Nove de Julho Universtiy	Sao Paulo	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Nove de Julho	Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Country where clinical trial is conducted

Brazil, 

References & Publications (10)

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. — View Citation

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. — View 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. — View 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. — View 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. Review. — View 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. — View Citation

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

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. — View Citation

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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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.	Samples collected 1 minute after the application of laser, radiofrequency or lidocaine