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

NCT ID: NCT04003545

Last Updated: 2019-07-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-01
• Study Completion Date: 2020-12-01

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

Study Design

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

Study Groups

Active group

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

Group Type: ACTIVE_COMPARATOR

LED Photobiomodulation

Intervention Type: 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.

Placebo group

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

Group Type: PLACEBO_COMPARATOR

Placebo LED Photobiomodulation

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: RADIATION

Placebo LED Photobiomodulation

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Nove de Julho

OTHER

Sponsor Role: lead

Responsible Party

Sandra Kalil Bussadori

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

TFilippo

Identifier Type: -

Identifier Source: org_study_id