Low Back PainNCT06007976
LLLT to Reduce Low Back Pain
A study testing Erchonia® Trident in people with Low Back Pain, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this research study is to gather information on the effectiveness of the Trident low-level laser therapy (LLLT) in combination with clinical patient education manuals to reduce lower back pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Erchonia® Trident
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Feb 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Reporting a primary pain point in lower back.
- Pain intensity reported at baseline must be 4 and above on the Visual Analogue scale (PROMIS Numeric Rating Scale).
- Individual able to participate fully in all aspects of the study and have understood and signed study informed consent.
Who cannot join
- Have used pain medications or participated in a pain treatment within three days of study enrollment.
- Have an implanted device (including lap band) in the targeted area of Low Level Laser Treatment.
- Have used an investigational drug within 30 days of study enrollment.
- Reports being currently pregnant, lactating, or are of child-bearing potential or are likely to become pregnant during the low level laser treatment phase and are unwilling to use a reliable form of contraception. Acceptable forms of contraception include: Hormonal methods, such as birth control pills, patches, injections, vaginal ring, or implants; Barrier methods (such as a condom or diaphragm) used with a spermicide (a foam, cream, or gel that kills sperm); Intrauterine device (IUD); Total hysterectomy or tubal ligation; Abstinence (no sex).
- Have a history of any major cardiovascular events including heart valve disease, ongoing angina, cardiac arrhythmias, congestive heart failure, acute coronary syndrome, stroke, transient ischemic attack, or peripheral vascular disease.
- 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.
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- Surgical intervention for pain within 1 month prior to enrollment.
- Active infection, wound or other external trauma to the areas to be treated with the laser
- Known photosensitivity disorder.
- Have a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder adherence.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Variable Treatment Frequencies of Low-Level Laser in Reduce Low-Back Pain
The purpose of this research study is to gather information on the effectiveness of the Trident low-level laser therapy (LLLT) in combination with clinical patient education manuals to reduce lower back pain.
Read the detailed description
Patients will be administered one of 4 treatment options using the Trident LLLT. The treatment options include 2 treatments, 4 treatments, 6 treatments or 8 treatments. All patients will receive two self-help patient education manuals. Low Back Pain will be compared among all 4 options at the end of week 6.
- Conditions
- Low Back Pain
- Being tested
- Erchonia® Trident
- Keywords
- laser, LLLT, back pain, pain, low back pain
- Medical subject headings
- Low Back Pain, Back Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erchonia® TridentDevice
Low-level laser therapy
| Study group | Role | What they receive |
|---|---|---|
| 2 treatment | Experimental | Subjects will receive 2 low-level laser therapy treatments of 20 minutes for low back pain. Receives: Device: Erchonia® Trident |
| 4 treatment | Experimental | Subjects will receive 4 low-level laser therapy treatments of 20 minutes over 2 weeks for low back pain. Receives: Device: Erchonia® Trident |
| 6 treatment | Experimental | Subjects will receive 6 low-level laser therapy treatments of 20 minutes over 3 weeks for low back pain. Receives: Device: Erchonia® Trident |
| 8 treatment | Experimental | Subjects will receive 8 low-level laser therapy treatments of 20 minutes over 4 weeks for low back pain. Receives: Device: Erchonia® Trident |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Brief Pain Inventory score
The PROMIS Numeric Rating Scale v1.0 - Pain Intensity 1a will be used to measure pain intensity on a VAS scale where '0' is no pain and '10' being the worst imaginable pain.
Measured: Baseline, Week 6
Change in Brief Pain Inventory score
The PROMIS Numeric Rating Scale v1.0 - Pain Intensity 1a will be used to measure pain intensity on a VAS scale where '0' is no pain and '10' being the worst imaginable pain.
Measured: Baseline, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start16 Feb 2024
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- All patients will self-select one of four treatment options: 1 week (2 treatment), 2 weeks (4 treatments), 3 weeks (6 treatments) and 4 weeks (8 treatments).
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Erchonia Corporation
- Responsible party
- Principal investigator, Ivana T Croghan, PhD, Mayo Clinic
- Investigators
- Ivana T Croghan, PhD, Principal investigator, Mayo ClinicRyan T Hurt, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06007976
- Sponsor's protocol ID
- 23-004998
- Status last verified
- Mar 2026
- First submitted
- 17 Aug 2023
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Variable Treatment Frequencies of Low-Level Laser in Reduce Low-Back Pain
- ClinicalTrials.gov ID
- NCT06007976
- Acronym / sponsor ID
- 23-004998
- Conditions
- Low Back Pain
- Keywords
- laser, LLLT, back pain, pain, low back pain
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Erchonia Corporation
- Study start
- 16 Feb 2024 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 23 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to gather information on the effectiveness of the Trident low-level laser therapy (LLLT) in combination with clinical patient education manuals to reduce lower back pain.
Detailed description
Patients will be administered one of 4 treatment options using the Trident LLLT. The treatment options include 2 treatments, 4 treatments, 6 treatments or 8 treatments. All patients will receive two self-help patient education manuals. Low Back Pain will be compared among all 4 options at the end of week 6.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- All patients will self-select one of four treatment options: 1 week (2 treatment), 2 weeks (4 treatments), 3 weeks (6 treatments) and 4 weeks (8 treatments).
| Arm | Type | Receives |
|---|---|---|
| 2 treatment | Experimental | Device: Erchonia® TridentSubjects will receive 2 low-level laser therapy treatments of 20 minutes for low back pain. |
| 4 treatment | Experimental | Device: Erchonia® TridentSubjects will receive 4 low-level laser therapy treatments of 20 minutes over 2 weeks for low back pain. |
| 6 treatment | Experimental | Device: Erchonia® TridentSubjects will receive 6 low-level laser therapy treatments of 20 minutes over 3 weeks for low back pain. |
| 8 treatment | Experimental | Device: Erchonia® TridentSubjects will receive 8 low-level laser therapy treatments of 20 minutes over 4 weeks for low back pain. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Reporting a primary pain point in lower back.
- Pain intensity reported at baseline must be 4 and above on the Visual Analogue scale (PROMIS Numeric Rating Scale).
- Individual able to participate fully in all aspects of the study and have understood and signed study informed consent.
Key exclusion criteria (10 listed)
- Have used pain medications or participated in a pain treatment within three days of study enrollment.
- Have an implanted device (including lap band) in the targeted area of Low Level Laser Treatment.
- Have used an investigational drug within 30 days of study enrollment.
- Reports being currently pregnant, lactating, or are of child-bearing potential or are likely to become pregnant during the low level laser treatment phase and are unwilling to use a reliable form of contraception. Acceptable forms of contraception include: Hormonal methods, such as birth control pills, patches, injections, vaginal ring, or implants; Barrier methods (such as a condom or diaphragm) used with a spermicide (a foam, cream, or gel that kills sperm); Intrauterine device (IUD); Total hysterectomy or tubal ligation; Abstinence (no sex).
- Have a history of any major cardiovascular events including heart valve disease, ongoing angina, cardiac arrhythmias, congestive heart failure, acute coronary syndrome, stroke, transient ischemic attack, or peripheral vascular disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erchonia® TridentLow-level laser therapy | Device | 2 treatment, 4 treatment, 6 treatment, 8 treatment |
Primary outcome
Change in Brief Pain Inventory score
Time frame: Baseline, Week 6
The PROMIS Numeric Rating Scale v1.0 - Pain Intensity 1a will be used to measure pain intensity on a VAS scale where '0' is no pain and '10' being the worst imaginable pain.
Change in Brief Pain Inventory score
Time frame: Baseline, Week 24
The PROMIS Numeric Rating Scale v1.0 - Pain Intensity 1a will be used to measure pain intensity on a VAS scale where '0' is no pain and '10' being the worst imaginable pain.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ivana T Croghan, PhD principal investigator
Mayo Clinic
Ryan T Hurt, MD, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erchonia® Trident in people with Low Back Pain, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Brief Pain Inventory score (time frame: Baseline, Week 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.