NCT06282770 · University of California, Los Angeles
Photobiomodulation for Lower Back Pain Post Spinal Fusion and Decompression Surgery
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
Laser Diode Brace
The device is a brace with laser diodes. The braces light up and the red light has therapeutic abilities.
DEVICE
Sham Laser Diode Brace
The Sham brace has no therapeutic ability and will act as a placebo.
Primary outcome measures
Self-reported patient outcome questionnaires after photobiomodulation therapy - VAS
Time frame: 3 months
Subjects will fill out two questionnaires related to their pain and quality of life before and after surgery with laser diode brace photobiomodulation therapy. The first survey is the Visual Analog Scale (VAS), which asks subjects to state how good or bad their current health state is on a scale of 0-100, 1 being the worst imaginable health state and 100 being the best imaginable health state. There are two additional questions that ask subjects to provide a rate their current back and leg pain on a scale of 0-10, with 0 being no pain and 10 being worst imaginable pain.
Self-reported patient outcome questionnaires after photobiomodulation therapy - ODI
Time frame: 3 months
The second survey is the Oswestry Disability Index (ODI), which is designed to provide information on how the subject's pain is affecting their everyday life. There are 10 sections on the survey each graded on a scale from 0-5 with 5 being the most impaired. The total score scales from 0-50, where 0-10 denotes minimal disability and 40-50 denotes that the pain impinges on all aspects of their daily lives.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Los Angeles, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 13, 2026 · Source of record for eligibility and locations