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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04476095
• Other study ID #: 2.732.044
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 15, 2020
• Est. completion date: September 30, 2020

Study information

• Verified date: July 2020
• Source: University of Nove de Julho
• Contact: Ernesto Cesar Pinto Leal Junior, PhD
• Phone: +55 11 33859134
• Email: ernesto.leal.junior[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 72
• Est. completion date: September 30, 2020
• Est. primary completion date: September 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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 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).

Locations

Country	Name	City	State
Brazil	Laboratory of Phototherapy and Innovative Technologies in Health	São Paulo

Sponsors (3)

Lead Sponsor	Collaborator
University of Nove de Julho	Fundação de Amparo à Pesquisa do Estado de São Paulo, Multi Radiance Medical

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity	Pain intensity will be measured by 0-100 standardized Visual Analog Scale (VAS).	3 weeks (end of treatment)
Secondary	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).
Secondary	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).
Secondary	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.