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Laser Diode Brace for Lower Back Pain After Spinal Fusion
N/A
Recruiting
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age > 18 years
Subject will have undergone minimally invasive spinal fusion surgery or spinal decompression surgery in their lower back L1-S1
Must not have
Current infection
Severe spondylolisthesis, spondylolysis, spinal stenosis, ankylosing spondylitis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Summary
This trial aims to study the use of high-power laser diodes to reduce pain and inflammation in patients who have undergone spinal fusion surgery. They will compare the effectiveness of a back brace with laser diodes
Who is the study for?
This trial is for individuals experiencing chronic lower back pain following spinal fusion and decompression surgery. Participants should be recovering from the surgery and looking for non-medication methods to manage pain and inflammation.
What is being tested?
The study compares two types of braces: one with laser diodes that may reduce pain and inflammation, versus a sham (placebo) brace without active lasers. The effect on post-surgical wound healing will also be assessed.
What are the potential side effects?
Potential side effects are not specified, but as this involves non-invasive laser therapy, risks may include skin irritation at the site of application or discomfort due to wearing the brace.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am older than 18 years.
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I have had minimally invasive surgery on my lower back.
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I speak English to avoid misunderstandings about using the belt.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently fighting an infection.
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I have a severe spine condition.
Select...
I cannot use a laser belt due to my skin condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Self-reported patient outcome questionnaires after photobiomodulation therapy - ODI
Self-reported patient outcome questionnaires after photobiomodulation therapy - VAS
Secondary study objectives
Stony Brook Scar Evaluation
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Brace With Electrical DiodesExperimental Treatment1 Intervention
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.
Group II: Sham Brace Without Electrical DiodesPlacebo Group1 Intervention
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.
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Who is running the clinical trial?
University of California, Los AngelesLead Sponsor
1,569 Previous Clinical Trials
10,314,215 Total Patients Enrolled
Adreanne Rivera, BSStudy DirectorUniversity of California, Los Angeles
Sichen Li, PhDStudy DirectorUniversity of California, Los Angeles
Sara K Chung, PAStudy DirectorUniversity of California, Los Angeles
Sandra M Holley, PhDStudy DirectorUniversity of California, Los Angeles