Clinical trial NCT04476095: Photobiomodulation Therapy (PBMT) in Patients With Low Back Pain (LBP)
Official title: Effects of Photobiomodulation Therapy (PBMT) on Pain Intensity in Patients With Low Back Pain (LBP)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Keywords: Photobiomodulation Therapy
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
Collaborators: name: Multi Radiance Medical
name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2020-07-17
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Low back pain (LBP) is a highly prevalent condition worldwide and the leading cause of years lived with disability. In most cases, the specific pathological cause remains unidentified; therefore, the term non-specific low back pain is commonly used for such cases. Many non-pharmacological therapies are available for the treatment of low back pain aiming to reduce pain and disability. Among these options, photobiomodulation therapy (PBMT) it seems to be an interesting alternative. PBMT is a non-thermal and non-invasive clinical treatment, which has shown effects in decreased pain, modulation of inflammatory process, and tissue repair in musculoskeletal disorders. Therefore, the aim of this project is to evaluate the effects of the PBMT against placebo on pain intensity in patients with chronic non-specific low back pain.

Detailed description: To achieve the proposed objective, it will be performed a randomized, triple-blind (patients, therapists, and outcome assessors), placebo-controlled trial.

Seventy-two patients with chronic non-specific low back pain will be randomly allocated to two treatment groups: 1. Active PBMT or Placebo PBMT.

In both groups, six treatment sessions will be performed twice a week (at the same time of the day), with intervals of three or four days between sessions, during three-week period. The patients will be treated by a blinded therapist.

The outcomes will be obtained at stabilization phase (during 2 weeks), baseline, end of treatment, 24, 48 and 72 hours after the last treatment session, and 7 days after conclusion of treatment. The data will be collected by a blinded assessor.

Statistical analyzis:

* The Fischer's Exact Test will be conducted to compare the proportion of successes between groups.
* The Unpaired t-test will be used for demographic data.
* Repeated measures ANOVA will be performed to analyze pain intensity. The level of statistical significance will be set at p\<0.05.

Eligibility criteria: Inclusion Criteria:

* Patients with chronic non-specific low back pain, with symptoms present for at least three months;
* Patients with a pain intensity of at least 50mm (measured by a 0-100 mm Visual Analog Scale);

Exclusion Criteria:

* Serious spinal pathologies (such as fractures, tumors, inflammatory, and infectious diseases);
* Patients who used local corticosteroids and/or botulin toxin injection for pain relief within the prior 30 days of the beginning of the study;
* Chronic pain diseases as fibromyalgia and diabetic type 1;
* Neuropathic pain;
* Previous spinal surgery in the past 12 months;
* Cancer patients;
* Pregnancy or breast feeding.

Primary outcomes:
measure: Pain intensity
timeFrame: 3 weeks (end of treatment)
Secondary outcomes:
measure: Subject satisfaction
timeFrame: 3 weeks (end of treatment).
measure: Control of concomitant medication intake
timeFrame: 3 weeks (end of treatment).
measure: Pain intensity
timeFrame: 24 hours, 48 hours, and 72 hours after the last treatment session, and 7 days after conclusion of treatment.
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Laboratory of Phototherapy and Innovative Technologies in Health
Study officials:
References: