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

• ClinicalTrials.gov Identifier: NCT04476095
• Recruitment Status: Unknown
• First Posted: July 17, 2020
• Last Update Posted: July 17, 2020
• Sponsor: University of Nove de Julho
• Collaborators: Multi Radiance Medical; Fundação de Amparo à Pesquisa do Estado de São Paulo
• Information provided by (Responsible Party): Ernesto Cesar Pinto Leal Junior, University of Nove de Julho

Tracking Information

• First Submitted Date: July 9, 2020
• First Posted Date: July 17, 2020
• Last Update Posted Date: July 17, 2020
• Estimated Study Start Date: July 15, 2020
• Estimated Primary Completion Date: September 2, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 13, 2020)

Pain intensity [ Time Frame: 3 weeks (end of treatment) ]

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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: July 13, 2020)

• Subject satisfaction [ Time Frame: 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".
• Control of concomitant medication intake [ Time Frame: 3 weeks (end of treatment). ]
  The control of concomitant medication intake will be measured by a individualized pain management diary.
• Pain intensity [ Time Frame: 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).

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Photobiomodulation Therapy (PBMT) in Patients With Low Back Pain (LBP)
• Official Title: Effects of Photobiomodulation Therapy (PBMT) on Pain Intensity in Patients With Low Back Pain (LBP)
• 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 Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

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).

Primary Purpose: Treatment

• Condition: 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.
• 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).

Study Arms

• 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).
  Intervention: Device: Active PBMT
• 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).
  Intervention: Device: Placebo PBMT

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: July 13, 2020): 72
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 30, 2020
• Estimated Primary Completion Date: September 2, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Brazil

Administrative Information

• NCT Number: NCT04476095
• Other Study ID Numbers: 2.732.044
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Ernesto Cesar Pinto Leal Junior, University of Nove de Julho
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Nove de Julho
• Original Study Sponsor: Same as current

Collaborators

• Multi Radiance Medical
• Fundação de Amparo à Pesquisa do Estado de São Paulo

• Investigators: Not Provided
• PRS Account: University of Nove de Julho
• Verification Date: July 2020