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Completed

NCT Number: NCT02529670

Low Level Laser Therapy in the Dorsal Root Ganglion in the 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.

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Key information

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nove de Julho Universtiy

São Paulo, 01321001, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LASER

Procedure

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

Drug: Lidocaine

Procedure

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

Radiofrequency

Procedure

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Nove de Julho

Other

Collaborators

  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 20, 2015
Registry last updated
Jun 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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