Utilizing Photobiomodulation Via Laser Diode Belts to Treat Chronic Lower Back Pain in Patients Who Have Undergone Spinal Fusion and Decompression Surgery

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
United States
California
Semel Institute of Neuroscience at UCLA
RECRUITING
Los Angeles
UCLA Clinical and Translational Research Center
RECRUITING
Los Angeles
Contact Information
Primary
Daniel Lu, Md, PhD
DCLu@mednet.ucla.edu
310-267-2975
Backup
Sandra Holley, PhD
sholley@mednet.ucla.edu
3108252763
Time Frame
Start Date: 2023-07-01
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 80
Treatments
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, 12, 24, 36 and 48 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, 12, 24, 36 and 48 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.
Related Therapeutic Areas
Sponsors
Leads: University of California, Los Angeles

This content was sourced from clinicaltrials.gov