We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Photobiomodulation Therapy on Inflammatory Mediators on Low Back Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03859505
Recruitment Status : Completed
First Posted : March 1, 2019
Last Update Posted : April 1, 2019
Sponsor:
Collaborators:
Fundação de Amparo à Pesquisa do Estado de São Paulo
University of Bergen
Information provided by (Responsible Party):
Shaiane da Silva Tomazoni, Universidade Cidade de Sao Paulo

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Low back pain (LBP) is ranked as one of the most prevalent health conditions. It is likely that some inflammatory mediators could be associated with pain and disability in these patients. Photobiomodulation therapy (PBMT) is a non-pharmacological therapy often used in patients with LBP that decrease release of inflammatory mediators and accelerate muscle repair in different muscle skeletal conditions, as mechanisms of action. The present research project aims to evaluate the effects of PBMT on systemic levels of inflammatory markers and levels of pain intensity in patients with chronic non-specific low back pain.

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

Detailed Description:

This is a randomized, triple-blinded (therapist, assessor and patient), placebo-controlled trial, with voluntary patients with non-specific chronic low back pain.

Eighteen patients will be randomly allocated to two treatment groups: Placebo or PBMT and one single session of treatment will be provided.

The data will be collected by a blinded assessor and the outcomes of interest it will be levels of inflammatory markers and pain intensity and it will be collected at baseline and 15 minutes after the single session of treatment.

The statistical analysis will follow the intention-to-treat principles. The findings will be tested for their normality using the Shapiro-Wilk test. Parametric data will be expressed as mean and standard deviation and non-parametric data as median and respective upper and lower limits. Parametric data will be analyzed by two-way repeated measures analysis of variance (ANOVA; time versus experimental group) with post-hoc Bonferroni correction. Non-parametric data will be analyzed using the Friedman test and, secondarily, the Wilcoxon signed-rank test.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The mode of intervention (active or placebo PBMT) will be coded by an independent researcher. The randomization schedule will contain only codes (not the actual intervention). The output from the PBMT device is exactly the same from either the active or the placebo interventions. These features will guarantee that participants, therapists and outcomes assessor will be blinded to the treatment arms.
Primary Purpose: Treatment
Official Title: Effects of Photobiomodulation Therapy on Inflammatory Mediators in Patients With Chronic Non-specific Low Back Pain: a Randomized Placebo-controlled Trial
Actual Study Start Date : March 18, 2019
Actual Primary Completion Date : March 29, 2019
Actual Study Completion Date : March 29, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Placebo Comparator: Placebo PBMT
Application of PBMT (Photobiomodulation Therapy) without any dose (0 Joule).
 Device: Placebo PBMT
The PBMT treatments will be performed using the Multi Radiance Medical™ Super Pulsed Laser MR4™console (Solon, OH, USA), with the LS50 (emitter with an area of 20 cm2) and SE25 (emitter with an area of 4 cm2) cluster probes as emitters. Nine sites will be irradiated at patient's lumbar region: 3 central sites, using the SE25 (without any dose, 0 J); and 6 sites in the same direction, but laterally (both sides, 3 at a side), using the LS50 (without any dose, 0 J). Patients will be treated in a single session and they will receive a total dose of 0 J.
Active Comparator: Active PBMT
Application of PBMT (Photobiomodulation Therapy) active.
 Device: Active PBMT
The PBMT treatments will be performed using the Multi Radiance Medical™ Super Pulsed Laser MR4™ console (Solon, OH, USA), with the LS50 (emitter with an area of 20 cm2) and SE25 (emitter with an area of 4 cm2) cluster probes as emitters. Nine sites will be irradiated at patient's lumbar region: 3 central sites, using the SE25 (3000 Hz of frequency, 3 minutes of irradiation per site, 24.75 J per site, a totalizing 74.25 J irradiated from SE25); and 6 sites in the same direction, but laterally (both sides, 3 at a side), using the LS50 (1000 Hz of frequency, 3 minutes of irradiation per site, 24.30 J per site, a total of 145.80 J irradiated from LS50). Patients will be treated in a single session and will receive a total dose of 220.05 J.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Levels of prostaglandin E2 (PGE2) [ Time Frame: 15 minutes after the treatment ]
    Inflammation will be measured by blood samples


Secondary Outcome Measures :
  1. Levels of tumor necrosis factor alpha (TNF-a) [ Time Frame: 15 minutes after the treatment. ]
    Inflammation will be measured by blood samples.

  2. Levels of interleukin-6 (IL-6) [ Time Frame: 15 minutes after the treatment ]
    Inflammation will be measured by blood samples

  3. Pain Intensity [ Time Frame: 15 minutes after the treatment. ]
    Pain intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain Numerical Rating Scale), with 0 being "no pain" and 10 "the worst possible pain".


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with chronic non-specific low back pain (defined as pain or discomfort between the costal margins and the inferior gluteal folds, with or without referred symptoms in the lower limbs, for at least 3 month);
  • with a pain intensity of at least 3 points measured by a 0-10 points pain numerical rating scale;
  • aged between 18 and 65 years;

Exclusion Criteria:

  • evidence of nerve root compromise (i.e. one or more of motor, reflex or sensation deficit);
  • serious spinal pathology (such as fracture, tumor, inflammatory and infectious diseases);
  • serious cardiovascular and metabolic diseases;
  • previous back surgery;
  • pregnancy.
  • severe skin diseases (eg. skin cancer, erysipelas, severe eczema, severe dermatitis, severe psoriasis and severe hives lupus);
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT03859505


Locations
Layout table for location information
Norway
University of Bergen
Bergen, Norway, N-5018
Sponsors and Collaborators
Universidade Cidade de Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
University of Bergen
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Shaiane da Silva Tomazoni, Postdoctoral fellow and visiting researcher, Universidade Cidade de Sao Paulo
ClinicalTrials.gov Identifier: NCT03859505    
Other Study ID Numbers: 2018/1361
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data will be available upon requested of principal investigator.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shaiane da Silva Tomazoni, Universidade Cidade de Sao Paulo:
Low Back Pain
Photobiomodulation Therapy
PBMT
Low-Level Laser Therapy
LLLT
Additional relevant MeSH terms:
Layout table for MeSH terms
Back Pain
Low Back Pain
Pain
Neurologic Manifestations