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

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ClinicalTrials.gov Identifier: NCT04476095
Recruitment Status : Unknown
Verified July 2020 by Ernesto Cesar Pinto Leal Junior, University of Nove de Julho.
Recruitment status was:  Not yet recruiting
First Posted : July 17, 2020
Last Update Posted : July 17, 2020
Sponsor:
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Low Back Pain Device: Active PBMT Device: Placebo PBMT Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
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
Official Title: Effects of Photobiomodulation Therapy (PBMT) on Pain Intensity in Patients With Low Back Pain (LBP)
Estimated Study Start Date : July 15, 2020
Estimated Primary Completion Date : September 2, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arms and Interventions
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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).


Outcome Measures
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Primary Outcome Measures :
  1. Pain intensity [ Time Frame: 3 weeks (end of treatment) ]
    Pain intensity will be measured by 0-100 standardized Visual Analog Scale (VAS).


Secondary Outcome Measures :
  1. 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".

  2. 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.

  3. 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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04476095


Contacts
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Contact: Ernesto Cesar Pinto Leal Junior, PhD +55 11 33859134 ernesto.leal.junior@gmail.com

Locations
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Brazil
Laboratory of Phototherapy and Innovative Technologies in Health
São Paulo, Brazil, 01504-001
Sponsors and Collaborators
University of Nove de Julho
Multi Radiance Medical
Fundação de Amparo à Pesquisa do Estado de São Paulo
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Ernesto Cesar Pinto Leal Junior, Full professor, University of Nove de Julho
ClinicalTrials.gov Identifier: NCT04476095    
Other Study ID Numbers: 2.732.044
First Posted: July 17, 2020    Key Record Dates
Last Update Posted: July 17, 2020
Last Verified: July 2020

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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
Keywords provided by Ernesto Cesar Pinto Leal Junior, University of Nove de Julho:
Photobiomodulation Therapy
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations