Photobiomodulation for Lower Back Pain Post Spinal Fusion and Decompression Surgery

Spinal Fusion Clinical Trial

Official title: Utilizing Photobiomodulation Via Laser Diode Belts To Treat Chronic Lower Back Pain in Patients Who Have Undergone Spinal Fusion and Decompression Surgery

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

This study will review charts of 80 patients who have experienced chronic back pain at various operative sites of a teaching medical institution, including the inpatient academic medical center, outpatient ambulatory hospital, and regional trauma center. Deidentified demographic data that will be collected via extensive chart reviews include age, sex, BMI, preoperative diagnosis, pre- and post-operative pain scales, motor exams, and function questionnaires. Operative data will include operative time and estimated blood loss (EBL).

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, 12, 24, 36 and 48 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. ;

Related Conditions & MeSH terms

• Back Pain
• Chronic Lower Back Pain
• Low Back Pain
• Spinal Fusion

• NCT number: NCT06282770
• Study type: Interventional
• Source: University of California, Los Angeles
• Contact: Daniel Lu, Md, PhD
• Phone: 310-267-2975
• Email: DCLu@mednet.ucla.edu
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2023
• Completion date: July 1, 2025