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Photobiomodulation Therapy on Low Back Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03089424
Recruitment Status : Completed
First Posted : March 24, 2017
Last Update Posted : September 16, 2020
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Shaiane da Silva Tomazoni, Universidade Cidade de Sao Paulo

Study Description
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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.

Condition or disease Intervention/treatment Phase
Low Back Pain Device: Placebo PBMT Device: PBMT active Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Primary Purpose: Treatment
Official Title: Effects of Photobiomodulation Therapy in Patients With Chronic Non-specific Low Back Pain: a Randomized Placebo-controlled Trial
Actual Study Start Date : April 6, 2017
Actual Primary Completion Date : June 4, 2019
Actual Study Completion Date : June 20, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo PBMT
Application of PBMT (Photobiomodulation Therapy) without any dose (0 Joule) and The Back Book (educational information booklet).
 Device: Placebo PBMT
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.
Active Comparator: PBMT active
Application of PBMT (Photobiomodulation Therapy) active and The Back Book (educational information booklet).
 Device: PBMT active
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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03089424


Locations
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Brazil
Centre for Excellence in Clinical Research in Physiotherapy of Universidade Cidade de São Paulo
São Paulo, Sao Paulo, Brazil, 03071000
Sponsors and Collaborators
Universidade Cidade de Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
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Study Director: Leonardo Oliveira Pena Costa, PhD Universidade Cidade de Sao Paulo
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Shaiane da Silva Tomazoni, Postdoctoral fellow, Universidade Cidade de Sao Paulo
ClinicalTrials.gov Identifier: NCT03089424    
Other Study ID Numbers: 1.964.094
First Posted: March 24, 2017    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shaiane da Silva Tomazoni, Universidade Cidade de Sao Paulo:
low back pain, photobiomodulation therapy, LLLT
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations