Low Back Pain
Conditions
Keywords
low back pain, photobiomodulation therapy, LLLT
Brief summary
Photobiomodulation therapy (PBMT) is a non-pharmacological method commonly used in treatment of musculoskeletal disorders. However, there are few high-quality scientific evidence to support the effectiveness of this therapy in the treatment of patients with chronic low back pain, at short, medium and long term. The present research project aims to evaluate the effects of PBMT in patients with chronic non-specific low back pain.
Detailed description
This is a randomized, triple-blinded, placebo-controlled trial, with voluntary patients with chronic non-specific low back pain.One hundred and forty-eight patients will be randomly allocated to two treatment groups: Placebo or PBMT for 4 weeks (3 times per week, total of 12 sessions of 27 minutes each). The clinical outcomes will be obtained at the completion of treatment (4 weeks) and at 3, 6 and 12 months after randomization. The data will be collected by a blinded assessor. The statistical analysis will follow the intention-to-treat principles and the between-group differences will be calculated by using mixed linear models. The outcomes of interest are pain intensity, disability, function and global perceived effect.
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 during 12 sessions over a period of four weeks (three sessions/week). At each treatment session, patients will receive a total dose of 0 J. At the end of the 12 treatment sessions, patients will receive a total dose of 0 J.
DEVICEPBMT active
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 during 12 sessions over a period of four weeks (three sessions/week). At each treatment session, patients will receive a total dose of 220.05 J. At the end of the 12 treatment sessions, patients will receive a total dose of 2640.60 J.
Sponsors
Fundação de Amparo à Pesquisa do Estado de São Paulo
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 photobiomodulation) will be coded by an independent researcher. The randomization schedule will contain only codes (not the actual intervention). The output from the laser 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 seeking care for 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; * able to read Portuguese.
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity | 4 weeks after randomization | Pain intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS) |
| Disability | 4 weeks after randomization | Disability will be measured by the 24-item Roland Morris Disability Questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disability | 3, 6 and 12 months after randomization | Disability will be measured by the 24-item Roland Morris Disability Questionnaire |
| Pain intensity | 3, 6 and 12 months after randomization | Pain intensity will be measured by an 11-poin (0-10) Numerical Rating Scale (Pain NRS) |
| Function | 4 weeks, 3, 6 and 12 months after randomization | Function will be measured by an 11-point (0-10) Patient-Specific Functional Scale |
| Global perceived effect | 4 weeks, 3, 6 and 12 months after randomization | Global perceived effect will be measured by an 11-point (-5 to +5) Global Perceived Effect Scale |
Countries
Brazil
Outcome results
None listed