A Phase 1/2 interventional study of LED Photobiomodulation and Placebo LED Photobiomodulation in Low Back Pain, sponsored by University of Nove de Julho. Status unknown. Open to participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-01.
Sponsored by University of Nove de Julho · Phase 1/2, Interventional, and Treatment
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.
2,875 studies on the registry are indexed under Low Back Pain; 484 are open to participants now.
This study's planned enrollment of 76 is above the median of 60 across 2,315 interventional studies indexed under Low Back Pain.
Browse Low Back Pain studies →University of Nove de Julho is the lead sponsor of 246 studies on the registry; 52 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 1 (13%) have results posted.
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Exclusion Criteria:
Thirty eight patients will be recruited from UNINOVE outpatient units and randomly allocated in the two groups.
Radiation: LED Photobiomodulation
Thirty eight patients will be recruited from UNINOVE outpatient units and randomly allocated in the two groups.
Other: Placebo 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.
For the placebo group, the procedures will be the same, however the LED equipment will remain off.
Change in low back pain assessed by VAS (visual analog scale)
Patients will be present with a 10-cm ruler in which 0 means total absence of pain and 10 the maximum pain.
Time frame: Baseline (Before the first application of LED) and 4 weeks after (after the last application).
Change in disability assessed by Roland-Morris Disability Questionnaire (RMDQ)
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.
Time frame: Baseline (Before the first application of LED) and 4 weeks after (after the last application).
Change in range of motion assessed by Schöber test
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.
Time frame: Baseline (Before the first application of LED) and 4 weeks after (after the last application).
Change in disability assessed by Modified Oswestry Disability Questionnaire
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).
Time frame: Baseline (Before the first application of LED) and 4 weeks after (after the last application).
Change in Pressure Pain Threshold
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).
Time frame: Baseline (Before the first application of LED) and 4 weeks after (after the last application).
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