Photobiomodulation Therapy on Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

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.
    

Intervention name(s): Placebo PBMT; PBMT active
Intervention type(s): Device; Device
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: low back pain, photobiomodulation therapy, LLLT