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NCT Number: NCT03089424

Photobiomodulation Therapy on Low Back Pain

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Excellence in Clinical Research in Physiotherapy of Universidade Cidade de São Paulo

São Paulo, 03071000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo PBMT

Device

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.

PBMT active

Device

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.

Primary outcomes

  1. Pain Intensity

    Time frame: 4 weeks after randomization

    Pain intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS)

  2. Disability

    Time frame: 4 weeks after randomization

    Disability will be measured by the 24-item Roland Morris Disability Questionnaire

Secondary outcomes

  1. Pain intensity

    Time frame: 3, 6 and 12 months after randomization

    Pain intensity will be measured by an 11-poin (0-10) Numerical Rating Scale (Pain NRS)

  2. Disability

    Time frame: 3, 6 and 12 months after randomization

    Disability will be measured by the 24-item Roland Morris Disability Questionnaire

  3. Function

    Time frame: 4 weeks, 3, 6 and 12 months after randomization

    Function will be measured by an 11-point (0-10) Patient-Specific Functional Scale

  4. Global perceived effect

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Universidade Cidade de Sao Paulo

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

Effects of Photobiomodulation Therapy in Patients With Chronic Non-specific Low Back Pain: a Randomized Placebo-controlled Trial

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 24, 2017
Registry last updated
Sep 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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