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

Effects of Photobiomodulation Therapy (PBMT) on Pain Intensity in Patients With Low Back Pain (LBP)

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.

Study Overview

• Status: Unknown
• Conditions: Low Back Pain
• Intervention / Treatment: Device: Active PBMT; Device: Placebo PBMT

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 Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 01504-001
    • Laboratory of Phototherapy and Innovative Technologies in Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Device: Active PBMT; Active PBMT will be applied using a device with 152 emitters (wavelength - 808 nm; dose - 3000 J; treatment time - 600 s), in the low back region.
Placebo Comparator: 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).	Device: Placebo PBMT; The placebo PBMT will be applied using the same device as that of active PBMT but without any emission of therapeutic dose. Moreover, the irradiated site and the irradiation time were the same as that of active PBMT. Patients received a total dose of 0 J in the placebo mode. The sounds and signals emitted from the device as well as the information displayed on the screen will be identical, regardless of the type of treatment (active or placebo).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	Pain intensity will be measured by 0-100 standardized Visual Analog Scale (VAS).	3 weeks (end of treatment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject satisfaction	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".	3 weeks (end of treatment).
Control of concomitant medication intake	The control of concomitant medication intake will be measured by a individualized pain management diary.	3 weeks (end of treatment).
Pain intensity	Pain intensity will be measured by 0-100 standardized Visual Analog Scale (VAS).	24 hours, 48 hours, and 72 hours after the last treatment session, and 7 days after conclusion of treatment.

Collaborators and Investigators

• Sponsor: University of Nove de Julho
• Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo; Multi Radiance Medical

Study record dates

Study Major Dates

• Study Start (Anticipated): July 15, 2020
• Primary Completion (Anticipated): September 2, 2020
• Study Completion (Anticipated): September 30, 2020

Study Registration Dates

• First Submitted: July 9, 2020
• First Submitted That Met QC Criteria: July 13, 2020
• First Posted (Actual): July 17, 2020

Study Record Updates

• Last Update Posted (Actual): July 17, 2020
• Last Update Submitted That Met QC Criteria: July 13, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Photobiomodulation Therapy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 2.732.044

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes