Photobiomodulation Therapy on Low Back Pain

Universidade Cidade de Sao Paulo

Status

Completed

Conditions

Low Back Pain

Treatments

Device: PBMT active

Device: Placebo PBMT

Study type

Interventional

Funder types

Other

Identifiers

NCT03089424

1.964.094

Details and patient eligibility

About

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.

Full 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.

Enrollment

148 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.