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AzTrials

PainNCT02529670

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

A study testing Laser, Drug: Lidocaine and Radiofrequency in people with Pain and Low Back Pain, run by University of Nove de Julho at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 20 to 90 years
Conditions the study is for
Pain, Low Back Pain, Nociceptive Pain
What is being tested?
Laser, Drug: Lidocaine and Radiofrequency
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteBrazil
Study dates
Mar 2014to Dec 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Active lumbar cancer
  • Active infection
  • Coagulation disorders

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Nove de Julho Universtiy

    São Paulo, São Paulo, 01321001

Other trials in Brazil

About this study

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

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.

Being tested
Laser, Drug: Lidocaine, Radiofrequency
Keywords
Low Level Laser Therapy, Low Back Pain, Diagnosis, Genetic, Clinical trial
Medical subject headings
Pain, Low Back Pain, Nociceptive Pain, Neuralgia, Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LaserProcedure or surgery

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

  • Drug: LidocaineProcedure or surgery

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

  • RadiofrequencyProcedure or surgery

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

Study groups in NCT02529670
Study groupRoleWhat they receive
LaserExperimental15 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.
Receives: Procedure: Laser
RadiofrequencyActive comparator15 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.
Receives: Procedure: Radiofrequency
Drug: LidocaineActive comparatorIn 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.
Receives: Procedure: Drug: Lidocaine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 5 minutes before procedure

  2. 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).

    Measured: 5 minutes after procedure

  3. 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).

    Measured: 1 month and 6 months after procedure

Secondary outcomes (1)

  1. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2015 (estimated)
  2. Study startMar 2014
  3. Primary completionMar 2016
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02529670
Sponsor's protocol ID
53123716.3.0000.5511
Status last verified
Jun 2018
First submitted
11 Aug 2015
Last updated
18 Jun 2018
Results posted
No
Data monitoring committee
Yes

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. doi: 10.1097/00007632-198906000-00004.

    PubMed 2749371

  • 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.

    PubMed 7709270

  • 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.

    PubMed 17077742

  • 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.

    PubMed 16095934

  • 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.

    PubMed 1826550

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

    PubMed 11921711

  • 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.

    PubMed 20438798

  • 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.

    PubMed 21947908

  • 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.

    PubMed 22779441

  • 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.

    PubMed 21040142

Questions about this trial

What is this clinical trial studying?

A study testing Laser, Drug: Lidocaine and Radiofrequency in people with Pain and Low Back Pain, run by University of Nove de Julho at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Intensity Measure using Visual Analog Scale (time frame: 5 minutes before procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02529670, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2018.

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