Photobiomodulation Therapy (PBMT) in Patients With Low Back Pain (LBP)

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04476095
Study type	Interventional
Source	University of Nove de Julho
Contact	Ernesto Cesar Pinto Leal Junior, PhD
Phone	+55 11 33859134
Email	ernesto.leal.junior@gmail.com
Status	Not yet recruiting
Phase	N/A
Start date	July 15, 2020
Completion date	September 30, 2020

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.