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Device
Laser Therapy for Lower Back Pain
N/A
Recruiting
Led By Ivana T Croghan, PhD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 24
Awards & highlights
Study Summary
This trial will test if a laser therapy and education can reduce lower back pain.
Who is the study for?
This trial is for adults with lower back pain of intensity 4 or higher on the Visual Analogue scale. Participants must be able to engage fully in the study and have signed informed consent. Excluded are those who've used pain treatments recently, have implants in the treatment area, pregnant women not using contraception, anyone with major cardiovascular events, unstable diseases, recent surgery for pain, infections at treatment sites, photosensitivity disorders or other conditions as determined by the investigator.Check my eligibility
What is being tested?
The study tests how effective Erchonia® Trident low-level laser therapy (LLLT), combined with patient education manuals, is at reducing lower back pain. It aims to gather data on this non-invasive treatment's success rate in alleviating discomfort associated with lower back issues.See study design
What are the potential side effects?
While LLLT is generally considered safe and non-invasive, potential side effects may include temporary redness of skin, mild tingling sensation during treatment or slight irritation post-treatment. However specific side effects related to this particular device will be monitored throughout the trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 24
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Brief Pain Inventory score
Trial Design
4Treatment groups
Experimental Treatment
Group I: 8 treatmentExperimental Treatment1 Intervention
Subjects will receive 8 low-level laser therapy treatments of 20 minutes over 4 weeks for low back pain.
Group II: 6 treatmentExperimental Treatment1 Intervention
Subjects will receive 6 low-level laser therapy treatments of 20 minutes over 3 weeks for low back pain.
Group III: 4 treatmentExperimental Treatment1 Intervention
Subjects will receive 4 low-level laser therapy treatments of 20 minutes over 2 weeks for low back pain.
Group IV: 2 treatmentExperimental Treatment1 Intervention
Subjects will receive 2 low-level laser therapy treatments of 20 minutes for low back pain.
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Who is running the clinical trial?
Erchonia CorporationIndustry Sponsor
43 Previous Clinical Trials
1,939 Total Patients Enrolled
Mayo ClinicLead Sponsor
3,216 Previous Clinical Trials
3,767,428 Total Patients Enrolled
Ivana T Croghan, PhDPrincipal InvestigatorMayo Clinic
6 Previous Clinical Trials
309 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is recruitment still occurring for this trial?
"As per the information available on clinicaltrials.gov, this particular trial is not looking for patients at present. It was first posted on November 15th 2023 and last amended on August 17th 2023, yet there are 329 other medical studies currently searching for participants to participate in their research."
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