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Brace With Electrical Diodes for 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Self-reported patient outcome questionnaires after photobiomodulation therapy - ODI

Self-reported patient outcome questionnaires after photobiomodulation therapy - VAS

Secondary outcome measures

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 / 3Eligibility criteria met

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Who is running the clinical trial?

University of California, Los AngelesLead Sponsor

1,532 Previous Clinical Trials

10,265,188 Total Patients Enrolled

Sichen Li, PhDStudy DirectorUniversity of California, Los Angeles

Sandra M Holley, PhDStudy DirectorUniversity of California, Los Angeles

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible for me to participate in this medical study?

"Individuals eligible for participation in this research must have undergone spinal fusion surgery and fall within the age bracket of 18 to 75 years. The study has a capacity for enrolling a maximum of 80 participants."

Answered by AI

Are participants required to be of legal age in this investigation?

"Participants aged between 18 and 75 years old are eligible for inclusion in this clinical investigation. Notably, there are 17 studies targeting individuals under 18 years of age and a substantial number of 281 trials focusing on those above the age of 65."

Answered by AI

What is the current number of individuals enrolled in this clinical trial?

"Indeed, the details on clinicaltrials.gov highlight that this particular trial is actively seeking suitable candidates. Originally posted on July 1st, 2023, and recently revised on February 26th, 2024, the study aims to engage a total of 80 participants spread across two designated locations."

Answered by AI