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

June 14, 2018 updated by: Vanessa Milanesi Holanda, University of Nove de Julho

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
31

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • Sao Paulo, São Paulo, Brazil, 01321001
        • Nove de Julho Universtiy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Procedure: Laser
Low level laser therapy will be delivered through Laser Photon III ® (DMC) in the second lumbar dorsal root ganglion.
Active Comparator: 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.
Procedure: Radiofrequency
Radiofrequency will be delivered during 300 seconds, 42oC in the second lumbar dorsal root ganglion.
Active Comparator: 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.
Procedure: Drug: Lidocaine
1 mL of Lidocaine will be delivered in the second lumbar dorsal root ganglion through fluoroscopy.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
5 minutes before procedure
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).
5 minutes after procedure
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).
1 month and 6 months after procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Samples collected 1 minute after the application of laser, radiofrequency or lidocaine

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Nove de Julho

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 11, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 20, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 18, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 53123716.3.0000.5511

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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