Photobiomodulation Therapy (PBMT) in Patients With Low Back Pain (LBP)
NCT ID: NCT04476095
Last Updated: 2020-07-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
72 participants
INTERVENTIONAL
2020-07-15
2020-09-30
Brief Summary
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Detailed Description
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Seventy-two patients with chronic non-specific low back pain will be randomly allocated to two treatment groups: 1. Active PBMT or Placebo PBMT.
In both groups, six treatment sessions will be performed twice a week (at the same time of the day), with intervals of three or four days between sessions, during three-week period. The patients will be treated by a blinded therapist.
The outcomes will be obtained at stabilization phase (during 2 weeks), baseline, end of treatment, 24, 48 and 72 hours after the last treatment session, and 7 days after conclusion of treatment. The data will be collected by a blinded assessor.
Statistical analyzis:
* The Fischer's Exact Test will be conducted to compare the proportion of successes between groups.
* The Unpaired t-test will be used for demographic data.
* Repeated measures ANOVA will be performed to analyze pain intensity. The level of statistical significance will be set at p\<0.05.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Active PBMT
Active PBMT will be performed twice a week (at the same time of the day), with intervals of three or four days between sessions, during three-week period (a total of 6 sessions).
Active PBMT
Active PBMT will be applied using a device with 152 emitters (wavelength - 808 nm; dose - 3000 J; treatment time - 600 s), in the low back region.
Placebo PBMT
Placebo PBMT will be performed twice a week (at the same time of the day), with intervals of three or four days between sessions, during three-week period (a total of 6 sessions).
Placebo PBMT
The placebo PBMT will be applied using the same device as that of active PBMT but without any emission of therapeutic dose. Moreover, the irradiated site and the irradiation time were the same as that of active PBMT. Patients received a total dose of 0 J in the placebo mode. The sounds and signals emitted from the device as well as the information displayed on the screen will be identical, regardless of the type of treatment (active or placebo).
Interventions
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Active PBMT
Active PBMT will be applied using a device with 152 emitters (wavelength - 808 nm; dose - 3000 J; treatment time - 600 s), in the low back region.
Placebo PBMT
The placebo PBMT will be applied using the same device as that of active PBMT but without any emission of therapeutic dose. Moreover, the irradiated site and the irradiation time were the same as that of active PBMT. Patients received a total dose of 0 J in the placebo mode. The sounds and signals emitted from the device as well as the information displayed on the screen will be identical, regardless of the type of treatment (active or placebo).
Eligibility Criteria
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Inclusion Criteria
* Patients with a pain intensity of at least 50mm (measured by a 0-100 mm Visual Analog Scale);
Exclusion Criteria
* Patients who used local corticosteroids and/or botulin toxin injection for pain relief within the prior 30 days of the beginning of the study;
* Chronic pain diseases as fibromyalgia and diabetic type 1;
* Neuropathic pain;
* Previous spinal surgery in the past 12 months;
* Cancer patients;
* Pregnancy or breast feeding.
18 Years
ALL
No
Sponsors
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Multi Radiance Medical
INDUSTRY
Fundação de Amparo à Pesquisa do Estado de São Paulo
OTHER_GOV
University of Nove de Julho
OTHER
Responsible Party
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Ernesto Cesar Pinto Leal Junior
Full professor
Locations
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Laboratory of Phototherapy and Innovative Technologies in Health
São Paulo, , Brazil
Countries
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Central Contacts
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Other Identifiers
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2.732.044
Identifier Type: -
Identifier Source: org_study_id
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