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

NCT ID: NCT02529670

Last Updated: 2018-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2016-12-31

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.

Conditions

Pain; Low Back Pain; Nociceptive Pain; Neuropathic Pain; Low Level Laser Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Laser

Intervention Type: PROCEDURE

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

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.

Group Type: ACTIVE_COMPARATOR

Radiofrequency

Intervention Type: PROCEDURE

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

Drug: Lidocaine

In 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.

Group Type: ACTIVE_COMPARATOR

Drug: Lidocaine

Intervention Type: PROCEDURE

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

Interventions

Laser

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

Intervention Type: PROCEDURE

Drug: Lidocaine

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

Intervention Type: PROCEDURE

Radiofrequency

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

OTHER_GOV

Sponsor Role: collaborator

University of Nove de Julho

OTHER

Sponsor Role: lead

Responsible Party

Vanessa Milanesi Holanda

MD, MS

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Nove de Julho Universtiy

São Paulo, São Paulo, Brazil

Countries

Brazil

References

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Other Identifiers

53123716.3.0000.5511

Identifier Type: -

Identifier Source: org_study_id