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

Not Applicable

• Conditions: Low Back Pain
• Interventions: Device: Placebo PBMT; Device: Active PBMT

• Registration Number: NCT04476095
• Lead Sponsor: University of Nove de Julho

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.

Study Timeline

• Status Verified: 2020-07
• Study First Submitted: 2020-07-09
• Study First Submitted QC: 2020-07-13
• Last Update Submitted: 2020-07-13
• Study Start: 2020-07-15
• Study First Posted: 2020-07-17
• Last Update Posted: 2020-07-17
• Primary Completion: 2020-09-02
• Study Completion: 2020-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 72

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo PBMT	Placebo PBMT	Placebo PBMT 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 (a total of 6 sessions).
Active PBMT	Active PBMT	Active PBMT 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 (a total of 6 sessions).

Primary Outcome Measures

Name	Time	Method
Pain intensity	3 weeks (end of treatment)	Pain intensity will be measured by 0-100 standardized Visual Analog Scale (VAS).

Secondary Outcome Measures

Name	Time	Method
Control of concomitant medication intake	3 weeks (end of treatment).	The control of concomitant medication intake will be measured by a individualized pain management diary.
Subject satisfaction	3 weeks (end of treatment).	Subject satisfaction will be measured by scale uses the following responses: "very satisfied", "somewhat satisfied", "neither satisfied nor dissatisfied", "not very satisfied" or "not at all satisfied".
Pain intensity	24 hours, 48 hours, and 72 hours after the last treatment session, and 7 days after conclusion of treatment.	Pain intensity will be measured by 0-100 standardized Visual Analog Scale (VAS).

Trial Locations

Locations (1)

Laboratory of Phototherapy and Innovative Technologies in Health; 🇧🇷 São Paulo, Brazil