Photobiomodulation for Lower Back Pain Post Spinal Fusion and Decompression Surgery

NCT06282770 | Recruiting FDA Device

• 1 other identifier: IRB#23-000444
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Spinal Fusion; Chronic Lower Back Pain

Keywords

Photobiomodulation; Laser Diode; Inflammation; Spinal Fusion; Spinal Decompression; Lumbar; Back Pain

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  3 months

Secondary Outcomes (1)

• Stony Brook Scar Evaluation

  3 months

Study Arms (2)

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.

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.

Device: Sham Laser Diode Brace

Interventions

Laser Diode Brace DEVICE

The device is a brace with laser diodes. The braces light up and the red light has therapeutic abilities.

Also known as: Laser Brace

Brace With Electrical Diodes

Sham Laser Diode Brace DEVICE

The Sham brace has no therapeutic ability and will act as a placebo.

Also known as: Shame Brace

Sham Brace Without Electrical Diodes

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (2)

Semel Institute of Neuroscience at UCLA

Los Angeles, California, 90024, United States

RECRUITING

UCLA Clinical and Translational Research Center

Los Angeles, California, 90095, United States

RECRUITING

MeSH Terms

Conditions

Inflammation; Back Pain

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Sara K Chung, PA

  University of California, Los Angeles

  STUDY DIRECTOR

• Sandra M Holley, PhD

  University of California, Los Angeles

  STUDY DIRECTOR

• Sichen Li, PhD

  University of California, Los Angeles

  STUDY DIRECTOR

• Adreanne Rivera, BS

  University of California, Los Angeles

  STUDY DIRECTOR

Central Study Contacts

Daniel Lu, Md, PhD

CONTACT

310-267-2975; DCLu@mednet.ucla.edu

Sandra Holley, PhD

CONTACT

3108252763; sholley@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants in this study will not be told which belt is the sham diode brace or which is the functional diode brace. The assessor of the study will also be blinded to which belt each subject has, and data will be analyzed blindly based on patient ID alone.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurosurgeon

Model Details: 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.

Study Record Dates

• First Submitted: May 23, 2023
• First Posted: February 28, 2024
• Study Start: July 1, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)