Impact of Variable Treatment Frequencies of Low-Level Laser in Reduce Low-Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in Brief Pain Inventory score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
2 treatment
Subjects will receive 2 low-level laser therapy treatments of 20 minutes for low back pain.
干预措施: Erchonia® Trident (Device)
4 treatment
Subjects will receive 4 low-level laser therapy treatments of 20 minutes over 2 weeks for low back pain.
干预措施: Erchonia® Trident (Device)
6 treatment
Subjects will receive 6 low-level laser therapy treatments of 20 minutes over 3 weeks for low back pain.
干预措施: Erchonia® Trident (Device)
8 treatment
Subjects will receive 8 low-level laser therapy treatments of 20 minutes over 4 weeks for low back pain.
干预措施: Erchonia® Trident (Device)
结局指标
主要结局
Change in Brief Pain Inventory score
时间窗: 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.
次要结局
未报告次要终点
研究者
Ivana T Croghan, PhD
Principal Investigator
Mayo Clinic