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

NCT04003545 | Unknown Phase 1

• 1 other identifier: TFilippo
• Study Type: interventional
• Target: 76
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (Before the first application of LED) and 4 weeks after (after the last application).

Secondary Outcomes (4)

• Change in disability assessed by Roland-Morris Disability Questionnaire (RMDQ)

  Baseline (Before the first application of LED) and 4 weeks after (after the last application).

• Change in range of motion assessed by Schöber test

  Baseline (Before the first application of LED) and 4 weeks after (after the last application).

• Change in disability assessed by Modified Oswestry Disability Questionnaire

  Baseline (Before the first application of LED) and 4 weeks after (after the last application).

• Change in Pressure Pain Threshold

  Baseline (Before the first application of LED) and 4 weeks after (after the last application).

Study Arms (2)

Active group

ACTIVE COMPARATOR

Thirty eight patients will be recruited from UNINOVE outpatient units and randomly allocated in the two groups.

Radiation: LED Photobiomodulation

Placebo group

PLACEBO COMPARATOR

Thirty eight patients will be recruited from UNINOVE outpatient units and randomly allocated in the two groups.

Other: Placebo LED Photobiomodulation

Interventions

LED Photobiomodulation RADIATION

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.

Active group

Placebo LED Photobiomodulation OTHER

For the placebo group, the procedures will be the same, however the LED equipment will remain off.

Placebo group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;
• 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.

Sponsors & Collaborators

• University of Nove de Julho: lead

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: In the placebo group, the laser application will be simulated in the same way as the active group, but the device will be turned off. The outcome assessor will not know to which group the patients belong.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 25, 2019
• First Posted: July 1, 2019
• Study Start: August 1, 2019
• Primary Completion: August 1, 2020
• Study Completion: December 1, 2020
• Last Updated: July 1, 2019

Record last verified: 2019-06