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

NCT04476095 | Unknown FDA Device

• 1 other identifier: 2.732.044
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

Photobiomodulation Therapy

Outcome Measures

Primary Outcomes (1)

• Pain intensity

  Pain intensity will be measured by 0-100 standardized Visual Analog Scale (VAS).

  3 weeks (end of treatment)

Secondary Outcomes (3)

• Subject satisfaction

  3 weeks (end of treatment).

• Control of concomitant medication intake

  3 weeks (end of treatment).

• Pain intensity

  24 hours, 48 hours, and 72 hours after the last treatment session, and 7 days after conclusion of treatment.

Study Arms (2)

Active PBMT

EXPERIMENTAL

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

Placebo PBMT

PLACEBO COMPARATOR

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

Interventions

Active PBMT DEVICE

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.

Active PBMT

Placebo PBMT DEVICE

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).

Placebo PBMT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nove de Julho: lead
• Multi Radiance Medical: collaborator
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Laboratory of Phototherapy and Innovative Technologies in Health

São Paulo, 01504-001, Brazil

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ernesto Cesar Pinto Leal Junior, PhD

CONTACT

+55 11 33859134; ernesto.leal.junior@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A researcher will program the device (placebo PBMT or active PMBT) and will be instructed not to inform the patients or other researchers as to the type of treatment (PMBT or placebo). Therefore, the researcher responsible for the treatment, the investigator and the outcome assessor will be blinded to the type of treatment being administered to the patients. 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 (placebo or PBMT).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor

Study Record Dates

• First Submitted: July 9, 2020
• First Posted: July 17, 2020
• Study Start: July 15, 2020
• Primary Completion: September 2, 2020
• Study Completion: September 30, 2020
• Last Updated: July 17, 2020

Record last verified: 2020-07

Locations

BR (1)