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Abstract
Introduction Low back pain (LBP) is one of the largest and most frequent public health problems worldwide. Photobiomodulation therapy (PBMT) is a frequently used non-pharmacological therapy for the treatment of musculoskeletal disorders. However, there is little high-quality scientific evidence that demonstrates the effectiveness of PBMT in the treatment of patients with chronic LBP in the short, medium and long term. Therefore, the objective of this clinical trial is to evaluate the effects of PBMT in patients with chronic non-specific LBP in the short, medium and long term.
Methods and analyses This is a prospectively registered, two-arm randomised placebo-controlled trial with blinded patients, assessors and treatment providers. One hundred and forty-eight patients with chronic non-specific LBP will be recruited. Treatment sessions will be provided three times a week for 4 weeks (totaling 12 sessions) with patients receiving either placebo or active PBMT. For ethical reasons, all patients, regardless of treatment allocation, will also receive an information booklet based on ‘The Back Book’. Clinical outcomes will be measured at baseline, at the end of treatment, as well as 3, 6 and 12 months after randomisation. The primary outcomes will be pain intensity and disability measured after 12 sessions of treatment. The secondary outcomes will be pain intensity and disability measured at 3, 6 and 12 months after randomisation, in addition to specific disability and global perceived effect in all time points.
Ethics and dissemination The study was approved by the Research Ethics Committee of Universidade Cidade de São Paulo. The results will be disseminated through scientific publications and presentations at national and international scientific meetings.
Trial registration number NCT03089424.
- chronic low Back pain
- photobiomodulation therapy
- low-level laser therapy
- Lllt
- pbmt
This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
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Footnotes
Contributors SST and LOPC contributed to the concept and design of the study and established the hypothesis and wrote the original proposal. SST, LCMC, LSG, ACA, DPN, FCM, MAA and LOPC contributed significantly in creating the manuscript. LCMC and LOPC performed critical revisions of the manuscript. SST, LCMC and LOPC wrote the final version of the manuscript. All authors read and approved the final version of the manuscript.
Funding This work was supported by FAPESP (postdoctoral scholarship of Shaiane Silva Tomazoni) grant number 2016/10265-0.
Competing interests None declared.
Ethics approval Research Ethics Committee of Universidade Cidade de São Paulo (UNICID) under number 1.964.094.
Provenance and peer review Not commissioned; externally peer reviewed.