Clinical trial NCT03089424: Photobiomodulation Therapy on Low Back Pain
Official title: Effects of Photobiomodulation Therapy in Patients With Chronic Non-specific Low Back Pain: a Randomized Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: low back pain, photobiomodulation therapy, LLLT
Lead sponsor: Universidade Cidade de Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2017-03-24
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain Intensity
timeFrame: 4 weeks after randomization
measure: Disability
timeFrame: 4 weeks after randomization
Secondary outcomes:
measure: Pain intensity
timeFrame: 3, 6 and 12 months after randomization
measure: Disability
timeFrame: 3, 6 and 12 months after randomization
measure: Function
timeFrame: 4 weeks, 3, 6 and 12 months after randomization
measure: Global perceived effect
timeFrame: 4 weeks, 3, 6 and 12 months after randomization
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Centre for Excellence in Clinical Research in Physiotherapy of Universidade Cidade de São Paulo
state: Sao Paulo
Study officials:
affiliation: Universidade Cidade de Sao Paulo
name: Leonardo Oliveira Pena Costa, PhD
role: STUDY_DIRECTOR
References:
citation: Guimaraes LS, Costa LDCM, Araujo AC, Nascimento DP, Medeiros FC, Avanzi MA, Leal-Junior ECP, Costa LOP, Tomazoni SS. Photobiomodulation therapy is not better than placebo in patients with chronic nonspecific low back pain: a randomised placebo-controlled trial. Pain. 2021 Jun 1;162(6):1612-1620. doi: 10.1097/j.pain.0000000000002189.
citation: Tomazoni SS, Costa LDCM, Guimaraes LS, Araujo AC, Nascimento DP, Medeiros FC, Avanzi MA, Costa LOP. Effects of photobiomodulation therapy in patients with chronic non-specific low back pain: protocol for a randomised placebo-controlled trial. BMJ Open. 2017 Oct 24;7(10):e017202. doi: 10.1136/bmjopen-2017-017202.