protocolSection identificationModule nctId: NCT06282770, orgStudyIdInfo id: IRB#23-000444, briefTitle: Photobiomodulation for Lower Back Pain Post Spinal Fusion and Decompression Surgery, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-07-01, primaryCompletionDateStruct date: 2024-07-01, completionDateStruct date: 2025-07-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: University of California, Los Angeles, class: OTHER, descriptionModule briefSummary: After spinal fusion and decompression surgery there is a possible risk of developing chronic back pain. After surgery there is typically inflammation around the operation site and this inflammation can be painful and debilitating to patients.Many possible treatment plans have been incorporated to assist the patient with recovery - notably medications, physical therapy, and braces. However, few studies have looked at laser diodes that utilize high-power laser lights that are aimed at decreasing pain and inflammation. Investigators aim to look compare patients using a back brace with laser diodes within versus those who wear a normal brace used as a placebo. Investigators will also assess the patient's surgical wound to monitor the progression of wound healing while using the brace., conditionsModule conditions: Spinal Fusion, conditions: Chronic Lower Back Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Patients will come into clinic for consultation and enrollment in the study. They will have their first study visit where they will be given either and laser diode brace or a placebo brace. They will follow up with the physician after 2 weeks and then at 3, 6, 9 months and at 1 year to evaluate function and symptoms ., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Participants in this study will not be told which belt is the sham diode brace or which is the functional diode brace. The assessor of the study will also be blinded to which belt each subject has, and data will be analyzed blindly based on patient ID alone., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Laser Diode Brace, interventions name: Sham Laser Diode Brace, outcomesModule primaryOutcomes measure: Self-reported patient outcome questionnaires after photobiomodulation therapy - VAS, primaryOutcomes measure: Self-reported patient outcome questionnaires after photobiomodulation therapy - ODI, secondaryOutcomes measure: Stony Brook Scar Evaluation, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Semel Institute of Neuroscience at UCLA, status: RECRUITING, city: Los Angeles, state: California, zip: 90024, country: United States, contacts name: Daniel Lu, MD, PhD, role: CONTACT, phone: 310-267-2975, email: DCLu@mednet.ucla.edu, contacts name: Mark Yamamoto, BS, role: CONTACT, phone: 424-535-9634, email: MTYamamoto@mednet.ucla.edu, geoPoint lat: 34.05223, lon: -118.24368, locations facility: UCLA Clinical and Translational Research Center, status: RECRUITING, city: Los Angeles, state: California, zip: 90095, country: United States, contacts name: Daniel Lu, MD, PhD, role: CONTACT, phone: 310-267-2975, email: DCLu@mednet.ucla.edu, contacts name: Adreanne Rivera, BS, role: CONTACT, phone: 424-946-5712, email: adreannerivera@mednet.ucla.edu, geoPoint lat: 34.05223, lon: -118.24368, hasResults: False