Photobiomodulation Therapy on Inflammatory Mediators on Low Back Pain
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|ClinicalTrials.gov Identifier: NCT03859505|
Recruitment Status : Completed
First Posted : March 1, 2019
Last Update Posted : April 1, 2019
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|Condition or disease||Intervention/treatment||Phase|
|Low Back Pain||Device: Placebo PBMT Device: Active PBMT||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|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.|
|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|
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.
- Levels of prostaglandin E2 (PGE2) [ Time Frame: 15 minutes after the treatment ]Inflammation will be measured by blood samples
- Levels of tumor necrosis factor alpha (TNF-a) [ Time Frame: 15 minutes after the treatment. ]Inflammation will be measured by blood samples.
- Levels of interleukin-6 (IL-6) [ Time Frame: 15 minutes after the treatment ]Inflammation will be measured by blood samples
- 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".
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|Ages Eligible for Study:||18 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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;
- 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;
- severe skin diseases (eg. skin cancer, erysipelas, severe eczema, severe dermatitis, severe psoriasis and severe hives lupus);
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
|University of Bergen|
|Bergen, Norway, N-5018|
|Responsible Party:||Shaiane da Silva Tomazoni, Postdoctoral fellow and visiting researcher, Universidade Cidade de Sao Paulo|
|Other Study ID Numbers:||
|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.|
Informed Consent Form (ICF)
Clinical Study Report (CSR)
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
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