Photobiomodulation for Lower Back Pain Post Spinal Fusion and Decompression Surgery

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of California, Los Angeles
Study ID
NCT06282770
Status
Recruiting
Apply to this trial

Conditions

  • Chronic Lower Back Pain
  • Spinal Fusion

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Laser Diode Brace — DEVICE
    The device is a brace with laser diodes. The braces light up and the red light has therapeutic abilities.
  • Sham Laser Diode Brace — DEVICE
    The Sham brace has no therapeutic ability and will act as a placebo.

Study Details

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.

Key Dates

Start date
Jul 1, 2023
Status verified
Jan 2026
Primary completion
Jun 1, 2026
Completion
Jul 1, 2026

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Semel Institute of Neuroscience at UCLALos AngelesCalifornia90024
Daniel Lu, MD, PhD
[email protected]
310-267-2975
Mark Yamamoto, BS
[email protected]
424-535-9634
UCLA Clinical and Translational Research CenterLos AngelesCalifornia90095
Daniel Lu, MD, PhD
[email protected]
310-267-2975
Adreanne Rivera, BS
[email protected]
424-946-5712

Find similar trials in Los Angeles, CA

By research site
Semel Institute of Neuroscience at UCLA· Los Angeles, CAUCLA Clinical and Translational Research Center· Los Angeles, CA

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