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

Photobiomodulation Therapy on Low Back Pain

Sponsors

Lead sponsor: Universidade Cidade de Sao Paulo

Collaborator: Fundação de Amparo à Pesquisa do Estado de São Paulo

Source Universidade Cidade de Sao Paulo
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.

Overall Status Active, not recruiting
Start Date April 6, 2017
Completion Date September 2020
Primary Completion Date September 4, 2019
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Pain Intensity 4 weeks after randomization
Disability 4 weeks after randomization
Secondary Outcome
Measure Time Frame
Pain intensity 3, 6 and 12 months after randomization
Disability 3, 6 and 12 months after randomization
Function 4 weeks, 3, 6 and 12 months after randomization
Global perceived effect 4 weeks, 3, 6 and 12 months after randomization
Enrollment 148
Condition
Intervention

Intervention type: Device

Intervention name: Placebo PBMT

Description: 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.

Arm group label: Placebo PBMT

Intervention type: Device

Intervention name: PBMT active

Description: 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.

Arm group label: PBMT active

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.

Gender: All

Minimum age: 18 Years

Maximum age: 65 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Leonardo Oliveira Pena Costa, PhD Study Director Universidade Cidade de Sao Paulo
Location
facility Centre for Excellence in Clinical Research in Physiotherapy of Universidade Cidade de São Paulo
Location Countries

Brazil

Verification Date

March 2020

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Universidade Cidade de Sao Paulo

Investigator full name: Shaiane da Silva Tomazoni

Investigator title: Postdoctoral fellow

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Placebo PBMT

Arm group type: Placebo Comparator

Description: Application of PBMT (Photobiomodulation Therapy) without any dose (0 Joule) and The Back Book (educational information booklet).

Arm group label: PBMT active

Arm group type: Active Comparator

Description: Application of PBMT (Photobiomodulation Therapy) active and The Back Book (educational information booklet).

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking description: The mode of intervention (active or placebo photobiomodulation) will be coded by an independent researcher. The randomization schedule will contain only codes (not the actual intervention). The output from the laser device is exactly the same from either the active or the placebo interventions. These features will guarantee that participants, therapists and outcomes assessor will be blinded to the treatment arms.

Source: ClinicalTrials.gov