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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 below

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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:

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I am currently fighting an infection.

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I have a severe spine condition.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

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.

0 / 6Eligibility criteria met