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LLLT to Reduce Low Back Pain

Primary Purpose

Low Back Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Erchonia® Trident
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring laser, LLLT, back pain, pain, low back pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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. 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.

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

2 treatment

4 treatment

6 treatment

8 treatment

Arm Description

Subjects will receive 2 low-level laser therapy treatments of 20 minutes for low back pain.

Subjects will receive 4 low-level laser therapy treatments of 20 minutes over 2 weeks for low back pain.

Subjects will receive 6 low-level laser therapy treatments of 20 minutes over 3 weeks for low back pain.

Subjects will receive 8 low-level laser therapy treatments of 20 minutes over 4 weeks for low back pain.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 17, 2023
Last Updated
August 17, 2023
Sponsor
Mayo Clinic
Collaborators
Erchonia Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT06007976
Brief Title
LLLT to Reduce Low Back Pain
Official Title
Impact of Variable Treatment Frequencies of Low-Level Laser in Reduce Low-Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 15, 2023 (Anticipated)
Primary Completion Date
June 1, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
Erchonia Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
laser, LLLT, back pain, pain, low back pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
2 treatment
Arm Type
Experimental
Arm Description
Subjects will receive 2 low-level laser therapy treatments of 20 minutes for low back pain.
Arm Title
4 treatment
Arm Type
Experimental
Arm Description
Subjects will receive 4 low-level laser therapy treatments of 20 minutes over 2 weeks for low back pain.
Arm Title
6 treatment
Arm Type
Experimental
Arm Description
Subjects will receive 6 low-level laser therapy treatments of 20 minutes over 3 weeks for low back pain.
Arm Title
8 treatment
Arm Type
Experimental
Arm Description
Subjects will receive 8 low-level laser therapy treatments of 20 minutes over 4 weeks for low back pain.
Intervention Type
Device
Intervention Name(s)
Erchonia® Trident
Intervention Description
Low-level laser therapy
Primary Outcome Measure Information:
Title
Change in Brief Pain Inventory score
Description
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.
Time Frame
Baseline, Week 6
Title
Change in Brief Pain Inventory score
Description
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.
Time Frame
Baseline, Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shawn Fokken
Phone
507-293-2740
Email
Fokken.Shawn@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ivana T Croghan, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ryan T Hurt, MD, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

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LLLT to Reduce Low Back Pain

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