Low Back Pain
Conditions
Keywords
Low Back Pain, Photobiomodulation Therapy, PBMT, Low-Level Laser Therapy, LLLT
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.
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.
Interventions
DEVICEPlacebo 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.
DEVICEActive 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.
Sponsors
Fundação de Amparo à Pesquisa do Estado de São Paulo
University of Bergen
Universidade Cidade de Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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);
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Levels of prostaglandin E2 (PGE2) | 15 minutes after the treatment | Inflammation will be measured by blood samples |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Levels of tumor necrosis factor alpha (TNF-a) | 15 minutes after the treatment. | Inflammation will be measured by blood samples. |
| Levels of interleukin-6 (IL-6) | 15 minutes after the treatment | Inflammation will be measured by blood samples |
| Pain Intensity | 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. |
Countries
Norway
Outcome results
None listed