Condition or disease | Intervention/treatment | Phase |
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Low Back Pain | Radiation: LED Photobiomodulation Other: Placebo LED Photobiomodulation | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 76 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Outcomes Assessor) |
Masking Description: | In the placebo group, the laser application will be simulated in the same way as the active group, but the device will be turned off. The outcome assessor will not know to which group the patients belong. |
Primary Purpose: | Treatment |
Official Title: | Application of LED Photobiomodulation in the Treatment of Chronic Low Back Pain: a Randomized, Double-blind Clinical Trial |
Estimated Study Start Date : | August 1, 2019 |
Estimated Primary Completion Date : | August 1, 2020 |
Estimated Study Completion Date : | December 1, 2020 |
Arm | Intervention/treatment |
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Active Comparator: Active group
Thirty eight patients will be recruited from UNINOVE outpatient units and randomly allocated in the two groups.
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Radiation: LED Photobiomodulation
A total of twelve laser applications (3 sessions per week) will be provided to the patients as treatment. A LED board with wavelengths of 660nm and 850nm at 5mW of power will be used for 30 minutes, resulting in a total energy of 3J per point in each session. The application site will be the lumbar region, in contact with the skin. The LED cluster (light-emitting diodes) has 72 LEDs.
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Placebo Comparator: Placebo group
Thirty eight patients will be recruited from UNINOVE outpatient units and randomly allocated in the two groups.
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Other: Placebo LED Photobiomodulation
For the placebo group, the procedures will be the same, however the LED equipment will remain off.
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the patient will remain in the orthostatic position while the examiner positions his thumbs at the lower margin of the posterior superior iliac spine (PSIS) and draws a horizontal line in the midline between these two structures.
Then, the examiner firmly holds the tip of a measuring tape against the patient's skin on the marked line and marks a second line 15 cm above the first. The patient is then asked to flex the anterior trunk without increasing pain and a new measurement is marked between the lower and upper marks; finally, the patient returns to the neutral position. The difference between the initial distance (between the two marks on the skin in the neutral position) and the new measurement in the flexed position indicates the mobility of the lumbar spine in centimeters, with precision of millimeters.
Ages Eligible for Study: | 20 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
No Contacts or Locations Provided
Tracking Information | |||||
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First Submitted Date ICMJE | June 25, 2019 | ||||
First Posted Date ICMJE | July 1, 2019 | ||||
Last Update Posted Date | July 1, 2019 | ||||
Estimated Study Start Date ICMJE | August 1, 2019 | ||||
Estimated Primary Completion Date | August 1, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Change in low back pain assessed by VAS (visual analog scale) [ Time Frame: Baseline (Before the first application of LED) and 4 weeks after (after the last application). ] Patients will be present with a 10-cm ruler in which 0 means total absence of pain and 10 the maximum pain.
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Application of LED Photobiomodulation in the Treatment of Chronic Low Back Pain | ||||
Official Title ICMJE | Application of LED Photobiomodulation in the Treatment of Chronic Low Back Pain: a Randomized, Double-blind Clinical Trial | ||||
Brief Summary | Lumbar pain, or low back pain, may be defined as pain or discomfort located from the lower portion of the costal margin to the gluteal folds, with or without referred pain in the legs. This pain is classified as non-specific lumbar pain when its cause is unknown, as well as chronic when it persists for longer than three months with the appearance of disabilities for activities of daily life. Treatments for low back pain are usually pharmacological, focusing on analgesics, muscle relaxants and anti-inflammatories. Although protective factors, such as exercise, healthy diet and functional training may mitigate the evolution of pain, physical disability due to pain and functional loss reduce quality of life. Photobiomodulation (PBM) can be defined as the therapeutic use of light sources to reduce inflammation and relief pain. In this context, the objectives of this study are to develop and evaluate the effectiveness of an application protocol of an LED cluster for the treatment of chronic low back pain in a randomized, double-blind clinical trial that will be conducted in the outpatient facility of Universidade Nove de Julho (Uninove). Patients with chronic nonspecific low back pain, who signs the Informed Consent Form approved by the Uninove Institutional Review Board will be included in the study. Treatment sessions will be performed with a LED cluster three times a week for 4 weeks (totaling 12 sessions) in the lumbar region, and the outcomes will be measured with the following evaluations: VAS - Visual Analog Scale; Roland-Morris Disability Questionnaire (RMDQ); Schöber test; Modified Oswestry Disability Questionnaire and Algometry. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Outcomes Assessor) Masking Description: In the placebo group, the laser application will be simulated in the same way as the active group, but the device will be turned off. The outcome assessor will not know to which group the patients belong. |
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Condition ICMJE | Low Back Pain | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Unknown status | ||||
Estimated Enrollment ICMJE |
76 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 1, 2020 | ||||
Estimated Primary Completion Date | August 1, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 20 Years to 60 Years (Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Not Provided | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04003545 | ||||
Other Study ID Numbers ICMJE | TFilippo | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Sandra Kalil Bussadori, University of Nove de Julho | ||||
Study Sponsor ICMJE | University of Nove de Julho | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | University of Nove de Julho | ||||
Verification Date | June 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |