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

Not Applicable

Completed

• Conditions: Low Level Laser Therapy; Pain; Neuropathic Pain; Low Back Pain; Nociceptive Pain
• Interventions: Procedure: Laser; Procedure: Radiofrequency

• Registration Number: NCT02529670
• Lead Sponsor: University of Nove de Julho

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2015-08-11
• Study First Submitted QC: 2015-08-18
• Study First Posted: 2015-08-20
• Primary Completion: 2016-03
• Study Completion: 2016-12
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-14
• Last Update Posted: 2018-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laser	Laser	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.
Radiofrequency	Radiofrequency	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.

Primary Outcome Measures

Name	Time	Method
Pain Intensity Measure using the change in Visual Analog Scale from baseline at 1 month	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).
Pain Intensity Measure using Visual Analog Scale	5 minutes before procedure	Self reported pain intensity following Visual Analog Scale, scored 0-10 (0=no pain; 10=the worst pain ever).
Pain Intensity Measure using the Visual Analog Scale	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 Outcome Measures

Name	Time	Method
Immunochemistry to analyse IL-1, IL-10, TNF alfa.	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.

Trial Locations

Locations (1)

Nove de Julho Universtiy; 🇧🇷 Sao Paulo, São Paulo, Brazil