Actively Recruiting
Utilizing Photobiomodulation Via Laser Diode Belts To Treat Chronic Lower Back Pain in Patients Who Have Undergone Spinal Fusion and Decompression Surgery
Led by University of California, Los Angeles · Updated on 2026-01-13
80
Participants Needed
2
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of laser diode braces to manage chronic lower back pain following minimally invasive spinal fusion or decompression surgery. The study aims to compare the effects of a brace containing laser diodes versus a similar sham brace without therapeutic lasers, focusing on pain reduction, inflammation, and wound healing. This research is conducted at a teaching medical institution, involving 80 patients who have experienced chronic back pain at various surgical sites. Participants will be assigned randomly to wear either a laser diode brace or a sham brace that looks identical but lacks active laser diodes. They will wear the brace three times daily for 12 minutes each session over a 12-week period. The study includes two groups of 40 patients each undergoing spinal fusion or decompression surgery. Patients will complete pain and function questionnaires at 2, 4, 6, 8, and 12 weeks after surgery and submit photos of their surgical scars for wound healing assessment. Throughout the study, participants will use electronic submission to provide self-reported pain levels via the Visual Analogue Scale and function via the Oswestry-Low-Back-Pain-Disability Index. Surgical scar healing will be evaluated using image analysis software and a scar evaluation scale. Data collection will continue for 12 weeks, with all photos securely stored on encrypted servers. The study monitors progression of pain, function, and wound healing to assess the impact of the laser diode brace.
CONDITIONS
Brief Title
Photobiomodulation for Lower Back Pain Post Spinal Fusion and Decompression Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have undergone minimally invasive spinal fusion surgery or spinal decompression surgery in the lower back (L1-S1)
- Have low back pain lasting more than 3 months with a pain level above 4
- Are aged 18 years or older
- Speak English to ensure clear communication
- Had surgery at least 1 year but no more than 5 years before the study start date
You will not qualify if you...
- Patients with tumors
- Current infection
- History of drug misuse
- Skin conditions that prevent use of the laser belt
- Severe spondylolisthesis, spondylolysis, spinal stenosis, or ankylosing spondylitis
- Previous low back surgery performed more than 5 years before the study start date
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for consultation and enrollment
Duration - Surgery day and immediate recovery period
Participants undergo minimally invasive spinal fusion or decompression surgery and receive routine post-operative care.
Routine clinical visits as part of standard care
Duration - 12 weeks
Participants wear a laser diode brace or a sham brace 3 times per day for 12 minutes each session over 12 weeks post-surgery.
Participants submit questionnaires and photos electronically at 2, 4, 6, 8, and 12 weeks after surgery
Duration - Up to 12 weeks after surgery
Participants’ surgical scars and wound healing are evaluated using submitted photos and image analysis software to assess recovery.
5 electronic submissions of questionnaires and scar photos during treatment period
Trial Site Locations
Total: 2 locations
1
Semel Institute of Neuroscience at UCLA
Los Angeles, California, United States, 90024
Actively Recruiting
2
UCLA Clinical and Translational Research Center
Los Angeles, California, United States, 90095
Actively Recruiting
Research Team
D
Daniel Lu, Md, PhD
S
Sandra Holley, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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