RECRUITING

LLLT to Reduce Low Back Pain

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Impact of Variable Treatment Frequencies of Low-Level Laser in Reduce Low-Back Pain

Quick Facts

Study Start:2024-02-16

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06007976

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Shawn Fokken

CONTACT

507-293-2740

Fokken.Shawn@mayo.edu

Principal Investigator

Ivana T Croghan, PhD

PRINCIPAL_INVESTIGATOR

Mayo Clinic

Ryan T Hurt, MD, PhD

PRINCIPAL_INVESTIGATOR

Mayo Clinic

Study Locations (Sites)

Mayo Clinic

Rochester, Minnesota, 55905

United States

Collaborators and Investigators

Sponsor: Mayo Clinic

Ivana T Croghan, PhD, PRINCIPAL_INVESTIGATOR, Mayo Clinic
Ryan T Hurt, MD, PhD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-16

Study Completion Date2025-12

Study Record Updates

Study Start Date2024-02-16

Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

laser
LLLT
back pain
pain
low back pain

Additional Relevant MeSH Terms

Low Back Pain