Spinal FusionNCT06282770
Photobiomodulation for Lower Back Pain Post Spinal Fusion and Decompression Surgery
A study testing Laser Diode Brace in people with Spinal Fusion and Chronic Lower Back Pain, run by University of California, Los Angeles at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spinal Fusion, Chronic Lower Back Pain
- What is being tested?
- Laser Diode Brace
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jul 2023to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Semel Institute of Neuroscience at UCLA
Los Angeles, California, 90024
Daniel Lu, MD, PhD, 310-267-2975, DCLu@mednet.ucla.edu
Mark Yamamoto, BS, 424-535-9634, MTYamamoto@mednet.ucla.edu
- Recruiting
UCLA Clinical and Translational Research Center
Los Angeles, California, 90095
Daniel Lu, MD, PhD, 310-267-2975, DCLu@mednet.ucla.edu
Adreanne Rivera, BS, 424-946-5712, adreannerivera@mednet.ucla.edu
About this study
Official title: Utilizing Photobiomodulation Via Laser Diode Belts To Treat Chronic Lower Back Pain in Patients Who Have Undergone Spinal Fusion and Decompression Surgery
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.
Read the detailed 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, 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
- Spinal Fusion, Chronic Lower Back Pain
- Being tested
- Laser Diode Brace, Sham Laser Diode Brace
- Keywords
- Photobiomodulation, Laser Diode, Inflammation, Spinal Fusion, Spinal Decompression, Lumbar, Back Pain
- Medical subject headings
- Inflammation, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser Diode BraceDevice
Also called Laser Brace
The device is a brace with laser diodes. The braces light up and the red light has therapeutic abilities.
Sham Laser Diode BraceDevice
Also called Shame Brace
The Sham brace has no therapeutic ability and will act as a placebo.
| Study group | Role | What they receive |
|---|---|---|
| Brace With Electrical Diodes | Experimental | 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. Receives: Device: Laser Diode Brace |
| Sham Brace Without Electrical Diodes | Sham comparator | 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. Receives: Device: Sham Laser Diode Brace |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported patient outcome questionnaires after photobiomodulation therapy - VAS
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.
Measured: 3 months
Self-reported patient outcome questionnaires after photobiomodulation therapy - ODI
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.
Measured: 3 months
Secondary outcomes (1)
Stony Brook Scar Evaluation
Surgical scar healing will be examined to see if there is any promotion of wound healing due to the therapeutic advantage from the brace photobiomodulation therapy. Assessments include scar/wound size (in mm) and scar/wound healing using the Image J software.
The Stony Brook Scar Evaluation will score the scar from 0-5 where 5 shows significant healing.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start1 Jul 2023
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal FusionStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned in parallel to one of two arms (active photobiomodulation brace or sham brace). Assignment occurs once prior to surgery and remains fixed for the duration of the 12-week study. There is no crossover between arms.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Lu, MD, PhD, University of California, Los Angeles
- Investigators
- Sara K Chung, PA, Study director, University of California, Los AngelesSandra M Holley, PhD, Study director, University of California, Los AngelesSichen Li, PhD, Study director, University of California, Los AngelesAdreanne Rivera, BS, Study director, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06282770
- Sponsor's protocol ID
- IRB#23-000444
- Status last verified
- Jan 2026
- First submitted
- 23 May 2023
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing Photobiomodulation Via Laser Diode Belts To Treat Chronic Lower Back Pain in Patients Who Have Undergone Spinal Fusion and Decompression Surgery
- ClinicalTrials.gov ID
- NCT06282770
- Acronym / sponsor ID
- IRB#23-000444
- Conditions
- Spinal Fusion, Chronic Lower Back Pain
- Keywords
- Photobiomodulation, Laser Diode, Inflammation, Spinal Fusion, Spinal Decompression, Lumbar, Back Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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, 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are assigned in parallel to one of two arms (active photobiomodulation brace or sham brace). Assignment occurs once prior to surgery and remains fixed for the duration of the 12-week study. There is no crossover between arms.
| Arm | Type | Receives |
|---|---|---|
| Brace With Electrical Diodes | Experimental | Device: Laser Diode BraceThe 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. |
| Sham Brace Without Electrical Diodes | Sham comparator | Device: Sham Laser Diode BraceThe 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- Patients with tumors
- Current infection
- Drug misuse history
- Skin conditions preclude the use of laser belt
- Severe spondylolisthesis, spondylolysis, spinal stenosis, ankylosing spondylitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser Diode BraceAlso: Laser BraceThe device is a brace with laser diodes. The braces light up and the red light has therapeutic abilities. | Device | Brace With Electrical Diodes |
| Sham Laser Diode BraceAlso: Shame BraceThe Sham brace has no therapeutic ability and will act as a placebo. | Device | Sham Brace Without Electrical Diodes |
Primary outcome
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.
1 secondary outcome
Stony Brook Scar Evaluation
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sara K Chung, PA study director
University of California, Los Angeles
Sandra M Holley, PhD study director
University of California, Los Angeles
Sichen Li, PhD study director
University of California, Los Angeles
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser Diode Brace in people with Spinal Fusion and Chronic Lower Back Pain, run by University of California, Los Angeles at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Lu, Md, PhD (310-267-2975, DCLu@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported patient outcome questionnaires after photobiomodulation therapy - VAS (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.