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Recruiting NCT06282770

Photobiomodulation for Lower Back Pain Post Spinal Fusion and Decompression Surgery

Trial Parameters

Condition Spinal Fusion
Sponsor University of California, Los Angeles
Study Type INTERVENTIONAL
Phase N/A
Enrollment 80
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2023-07-01
Completion 2026-06-01
Interventions
Laser Diode BraceSham Laser Diode Brace

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: * Subject will have undergone minimally invasive spinal fusion surgery or spinal decompression surgery in their lower back L1-S1. * 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: * Patients with tumors * 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.

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