Application of LED Photobiomodulation in the Treatment of Chronic Low Back Pain

June 28, 2019 updated by: Sandra Kalil Bussadori, University of Nove de Julho

Application of LED Photobiomodulation in the Treatment of Chronic Low Back Pain: a Randomized, Double-blind Clinical Trial

Lumbar pain, or low back pain, may be defined as pain or discomfort located from the lower portion of the costal margin to the gluteal folds, with or without referred pain in the legs. This pain is classified as non-specific lumbar pain when its cause is unknown, as well as chronic when it persists for longer than three months with the appearance of disabilities for activities of daily life. Treatments for low back pain are usually pharmacological, focusing on analgesics, muscle relaxants and anti-inflammatories. Although protective factors, such as exercise, healthy diet and functional training may mitigate the evolution of pain, physical disability due to pain and functional loss reduce quality of life. Photobiomodulation (PBM) can be defined as the therapeutic use of light sources to reduce inflammation and relief pain. In this context, the objectives of this study are to develop and evaluate the effectiveness of an application protocol of an LED cluster for the treatment of chronic low back pain in a randomized, double-blind clinical trial that will be conducted in the outpatient facility of Universidade Nove de Julho (Uninove). Patients with chronic nonspecific low back pain, who signs the Informed Consent Form approved by the Uninove Institutional Review Board will be included in the study. Treatment sessions will be performed with a LED cluster three times a week for 4 weeks (totaling 12 sessions) in the lumbar region, and the outcomes will be measured with the following evaluations: VAS - Visual Analog Scale; Roland-Morris Disability Questionnaire (RMDQ); Schöber test; Modified Oswestry Disability Questionnaire and Algometry.

Study Overview

Status

Status

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

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 (Anticipated)

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.
76

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.
  • Phase 2
  • Phase 1

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 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical symptoms of vertebral pain that do not respond to symptomatic treatment with anti-inflammatory drugs for at least 3 months;
  • Moderate to severe pain measured by Visual Analogue Scale (VAS> 4);
  • Diagnosis of chronic nonspecific low back pain (as previously defined);
  • Signed Informed Consent Form to participate in the study and availability to visit the clinic for treatment and evaluations.

Exclusion Criteria:

  • Presence of other osteomuscular and rheumatic diseases;
  • Presence of symptoms and signs of osteomioarticular disease, even if without known diagnosis;
  • Clinical signs and complaints of osteomioarticular pain in the lower limbs (hips and ankles), as well as in spinal region;
  • Use of Photobiomodulation up to 90 days before the inclusion;
  • Clinical signs of neuropathy, including radiculopathy and peripheral nerve injury;
  • Presence of systemic inflammatory diseases (rheumatoid arthritis, Reiter arthritis, spondylitis ankylosing, generalized polyarthritis, neoplasia);
  • Presence of metabolic or endocrine diseases;
  • Presence of Fibromyalgia;
  • Presence of serious psychiatric disorders with demands for specialist care;
  • Use of steroids injections up to 48 hours before inclusion;
  • Infection or tumor in the area of Photobiomodulation application;
  • Presence of severe blood dyscrasias;
  • Presence of blood clotting disorders (including local thrombosis);
  • Use of oral anticoagulant;
  • Presence of Affective Psychotic Disorder that hinders adherence to the treatment;
  • History of lumbar surgery;
  • Patients who submit to government benefits due to low back pain.

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: Double

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.
Active Comparator: Active group
Thirty eight patients will be recruited from UNINOVE outpatient units and randomly allocated in the two groups.
Radiation: LED Photobiomodulation
A total of twelve laser applications (3 sessions per week) will be provided to the patients as treatment. A LED board with wavelengths of 660nm and 850nm at 5mW of power will be used for 30 minutes, resulting in a total energy of 3J per point in each session. The application site will be the lumbar region, in contact with the skin. The LED cluster (light-emitting diodes) has 72 LEDs.
Placebo Comparator: Placebo group
Thirty eight patients will be recruited from UNINOVE outpatient units and randomly allocated in the two groups.
Other: Placebo LED Photobiomodulation
For the placebo group, the procedures will be the same, however the LED equipment will remain off.

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
Change in low back pain assessed by VAS (visual analog scale)
Time Frame: Baseline (Before the first application of LED) and 4 weeks after (after the last application).
Patients will be present with a 10-cm ruler in which 0 means total absence of pain and 10 the maximum pain.
Baseline (Before the first application of LED) and 4 weeks after (after the last application).

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
Change in disability assessed by Roland-Morris Disability Questionnaire (RMDQ)
Time Frame: Baseline (Before the first application of LED) and 4 weeks after (after the last application).
This scale assesses physical abilities and psychological factors of patients, inquiring about functional changes of people with low back pain. It presents 24 questions about the conditions of the patient that characterize the presented incapacity. In all questions the phrase "because of my back" is added, and when it comes to answering them, the patient signals only the phrases that best suits him or her at that moment, otherwise the patient should go on to the next sentence. The total count of the marked items can range from a minimum of zero, considered no functional impairment, to a maximum of 24, high functional impairment.
Baseline (Before the first application of LED) and 4 weeks after (after the last application).
Change in range of motion assessed by Schöber test
Time Frame: Baseline (Before the first application of LED) and 4 weeks after (after the last application).

the patient will remain in the orthostatic position while the examiner positions his thumbs at the lower margin of the posterior superior iliac spine (PSIS) and draws a horizontal line in the midline between these two structures.

Then, the examiner firmly holds the tip of a measuring tape against the patient's skin on the marked line and marks a second line 15 cm above the first. The patient is then asked to flex the anterior trunk without increasing pain and a new measurement is marked between the lower and upper marks; finally, the patient returns to the neutral position. The difference between the initial distance (between the two marks on the skin in the neutral position) and the new measurement in the flexed position indicates the mobility of the lumbar spine in centimeters, with precision of millimeters.
Baseline (Before the first application of LED) and 4 weeks after (after the last application).
Change in disability assessed by Modified Oswestry Disability Questionnaire
Time Frame: Baseline (Before the first application of LED) and 4 weeks after (after the last application).
The Brazilian version of the Oswestry questionnaire allows the evaluation of the functional disability reported by the patients, based on the level of pain during different activities of daily life. This questionnaire contains ten questions about daily activities for evaluating the impact of pain on the performance of such activities. The results range from zero (minimum disability) to 100 (evident disability).
Baseline (Before the first application of LED) and 4 weeks after (after the last application).
Change in Pressure Pain Threshold
Time Frame: Baseline (Before the first application of LED) and 4 weeks after (after the last application).
The Pressure Pain Threshold (PPT) will be evaluated with the J Tech algometer (XXX). The algometer is a hand device with a 1cm² diameter rod and a rubber cover in its tip. It allows the recording, through the electronic device, the pressure applied on a surface. For this evaluation, a pressure will be applied at a constant rate of 1kg/sec to the level at which pain or discomfort is reported by the volunteer who will be lying on a stretcher. The evaluated muscles will be: gluteus medius; tensor fasciae latae; tibialis anterior; proximal ischiotibial (ischium); paravertebral muscle (lumbar L2-L5 and sacral S1-S3).
Baseline (Before the first application of LED) and 4 weeks after (after the last application).

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

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 (Anticipated)

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.
August 1, 2019

Primary Completion (Anticipated)

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.
August 1, 2020

Study Completion (Anticipated)

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, 2020

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).
June 25, 2019

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.
June 28, 2019

First Posted (Actual)

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.
July 1, 2019

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.
July 1, 2019

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 28, 2019

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, 2019

More Information

Terms related to this study

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.
  • TFilippo

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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