Photobiomodulation for Lower Back Pain Post Spinal Fusion and Decompression Surgery
NCT ID: NCT06282770
Last Updated: 2026-01-13
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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RECRUITING
NA
80 participants
INTERVENTIONAL
2023-07-01
2026-07-01
Brief Summary
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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.
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Detailed Description
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Patients that have already expressed interest in receiving spinal fusion or decompression surgery will come into clinic for consultation and enrollment in the study. Regardless of study participation, patients will receive either surgery. For the study, 80 subjects will be enrolled (40 with minimally invasive spinal fusion and 40 with minimally invasive decompression surgeries). Prior to the surgery date, subjects will complete pre-operation questionnaires that include the Visual Analogue Scale (VAS) and the Oswestry-Low-Back-Pain-Disability Index (ODI) to self-evaluate their current pain level and ability to perform basic lifestyle functions, respectively. Following surgery, enrolled subjects will then receive a brace that contains laser diodes or a sham (placebo) brace that appears identical to the diode-containing brace but lacks functional diodes. Subjects will wear the brace 3 times/day for 12 minutes each session for 12 weeks. They will complete and submit via the REDCap electronic submission portal the VAS and ODI questionnaires at the following time points after surgery: 2, 4, 6, 8, and 12 weeks. Subjects will also submit photos of their surgical scars for evaluation by the research study team members. Scar and wound healing will be assessed using image analysis software (Image J) according to the Stony Brook Scar Evaluation scale. Photos will be stored on a safe and secure encrypted server.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Brace With Electrical Diodes
The patient will be given a laser diode brace to wear for 1 year. At the defined time points following surgery (2, 4, 6, 8, and 12 weeks), subjects will be asked to complete pain and ability-to-function questionnaires and submit scar/wound images to determine their status at each time interval.
Laser Diode Brace
The device is a brace with laser diodes. The braces light up and the red light has therapeutic abilities.
Sham Brace Without Electrical Diodes
The patient will be given a sham/placebo laser diode brace to wear for 1 year. At the defined time points following surgery (2, 4, 6, 8, and 12 weeks), subjects will be asked to complete pain and ability-to-function questionnaires and submit scar/wound images to determine their status at each time interval.
Sham Laser Diode Brace
The Sham brace has no therapeutic ability and will act as a placebo.
Interventions
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Laser Diode Brace
The device is a brace with laser diodes. The braces light up and the red light has therapeutic abilities.
Sham Laser Diode Brace
The Sham brace has no therapeutic ability and will act as a placebo.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have low back pain of \>3 months and a pain threshold of \> 4 (as described by the the subject), age \> 18 years, and English speaking to eliminate possible miscommunication and consequent human error regarding belt use.
* Subject must have had surgery at minimum to 1 year prior to start of study and no more than 5 years prior to start to study
Exclusion Criteria
* Current infection
* Drug misuse history
* Skin conditions preclude the use of laser belt
* Severe spondylolisthesis, spondylolysis, spinal stenosis, ankylosing spondylitis
* Previous low back surgery exceeding 5 years to initial start date.
18 Years
75 Years
ALL
No
Sponsors
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University of California, Los Angeles
OTHER
Responsible Party
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Daniel Lu, MD, PhD
Neurosurgeon
Principal Investigators
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Sara K Chung, PA
Role: STUDY_DIRECTOR
University of California, Los Angeles
Sandra M Holley, PhD
Role: STUDY_DIRECTOR
University of California, Los Angeles
Sichen Li, PhD
Role: STUDY_DIRECTOR
University of California, Los Angeles
Adreanne Rivera, BS
Role: STUDY_DIRECTOR
University of California, Los Angeles
Locations
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Semel Institute of Neuroscience at UCLA
Los Angeles, California, United States
UCLA Clinical and Translational Research Center
Los Angeles, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRB#23-000444
Identifier Type: -
Identifier Source: org_study_id
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