Recruiting

Photobiomodulation

Sponsor:

UCLA

Code:

NCT06282770

Conditions

Spinal Fusion

Chronic Lower Back Pain

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Laser Diode Brace

Sham Laser Diode Brace

Study Details

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

Study ID

NCT06282770

Start date

Jul 1, 2023

Status verified date

Jan, 2026

Completion date

Jul 1, 2026

Anticipated

Primary completion date

Jun 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Brace With Electrical Diodes

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.

sham comparator: Sham Brace Without Electrical Diodes

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.

Interventions

Laser Diode Brace

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

Sham Laser Diode Brace

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

Primary outcome measure

  • Self-reported patient outcome questionnaires after photobiomodulation therapy - VAS [ Time Frame: 3 months ]
  • Self-reported patient outcome questionnaires after photobiomodulation therapy - ODI [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Daniel Lu, Md, PhD

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

Sandra Holley, PhD

3108252763sholley@mednet.ucla.edu

Locations

Semel Institute of Neuroscience at UCLA

Recruiting

Los Angeles, California, United States, 90024

Contacts

Daniel Lu, MD, PhD

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

Mark Yamamoto, BS

424-535-9634MTYamamoto@mednet.ucla.edu

UCLA Clinical and Translational Research Center

Recruiting

Los Angeles, California, United States, 90095

Contacts

Daniel Lu, MD, PhD

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

Adreanne Rivera, BS

424-946-5712adreannerivera@mednet.ucla.edu

More Information

Sponsor

University of California, Los Angeles

Last update posted

Jan 13, 2026

Last verified

Jan, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2026-01-13.