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Device

Laser Therapy for Lower Back Pain

N/A
Recruiting
Led By Ryan T Hurt, MD, 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
Must not have
Have clinically significant acute or chronic progressive or unstable neurologic, hepatic, renal, cardiovascular, lymphatic, respiratory, metabolic disease (such as uncontrolled diabetes type 2), active cancer, actively receiving l treatment for cancer or within 1 year of cancer remission.
Known photosensitivity disorder.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 24
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any unstable or serious health conditions, including uncontrolled diabetes or active cancer.
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I have a condition that makes my skin unusually sensitive to sunlight.
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I have an active infection or injury in the area where the laser will be used.
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I have had major heart or blood vessel problems.
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I am not pregnant, breastfeeding, or planning to become pregnant and will use effective birth control during the treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Brief Pain Inventory score

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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.

Find a Location

Who is running the clinical trial?

Erchonia CorporationIndustry Sponsor
44 Previous Clinical Trials
2,009 Total Patients Enrolled
2 Trials studying Low Back Pain
120 Patients Enrolled for Low Back Pain
Mayo ClinicLead Sponsor
3,343 Previous Clinical Trials
3,062,289 Total Patients Enrolled
10 Trials studying Low Back Pain
251,546 Patients Enrolled for Low Back Pain
Ryan T Hurt, MD, PhDPrincipal InvestigatorMayo Clinic
4 Previous Clinical Trials
455 Total Patients Enrolled
~24 spots leftby Jun 2025
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