Clinical trial NCT02529670: 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
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
Collaborators: name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
First posted: 2015-08-20
Enrollment: 31
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Pain Intensity Measure using Visual Analog Scale
timeFrame: 5 minutes before procedure
measure: Pain Intensity Measure using the change in Visual Analog Scale from baseline at 1 month
timeFrame: 5 minutes after procedure
measure: Pain Intensity Measure using the Visual Analog Scale
timeFrame: 1 month and 6 months after procedure
Secondary outcomes:
measure: Immunochemistry to analyse IL-1, IL-10, TNF alfa.
timeFrame: Samples collected 1 minute after the application of laser, radiofrequency or lidocaine
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Nove de Julho Universtiy
state: São Paulo
Study officials:
References:
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