Effect of LASER Photobiomodulation Therapy on Chronic Pain and Opioid Weaning
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- LiteCure LLC
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Compliance with Medical Opioid Use Reduction Protocol
研究概览
简要总结
This study will examine the effect of LASER photobiomodulation therapy on pain and opioid pain medication weaning on patients who are undergoing opioid pain medication weaning.
详细描述
The primary objective of this study is to determine if treatment with LASER photobiomodulation therapy reduces pain and facilitates opioid pain medication (OPM) reduction (weaning). The subject group includes patients with chronic pain who are undergoing OPM weaning and are candidates for LASER photobiomodulation therapy. This is a prospective interventional study using a double-blind 4-period crossover design to assess the efficacy of HIGH POWER LASER photobiomodulation therapy compared to sham (LOW POWER LASER) therapy in reducing pain and improving compliance with OPM weaning.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Sham therapy will consist of treatment using an identically appearing device that delivers low level LASER POWER to simulate LASER treatment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 or older.
- •Taking prescribed opioid pain medications in an amount in excess of 30 Morphine Equivalent Dose (MED) for 6 months or longer.
- •Have been recommended to wean or reduce their MED.
- •Medically stable such that subject does not have unstable angina, COPD requiring supplemental oxygen, untreated or active cancer or similar conditions that would make participation difficult or unsafe.
- •Compliant with all physician recommendations relating to medication usage.
- •Ambulatory and able to use the toilet independently.
- •Negative pregnancy test in subjects of childbearing potential
- •Willing to attempt opioid pain medication taper.
- •Competent to provide informed consent.
- •Capable of understanding and completing study questionnaires.
- •Subject willing to participate in the study for up to 12 weeks.
排除标准
- •Not capable of understanding or completing study questionnaires.
- •Lacking capacity to provide fully informed consent.
- •Substance use disorder not in remission.
- •Considering surgery or other invasive procedures that would take place during the study.
- •Used isotretinoin (Accutane) within 6 months prior to study enrollment
- •Cancer not in remission.
- •Need of ongoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy, massage therapy, chiropractic care or other treatments intended to remediate pain other than treatment in the Sharp Pain Program.
- •A female who is pregnant or lactating, or of childbearing potential unless a medically acceptable method of birth control is in use.
- •Any use of light-activated drugs (photodynamic therapy) or heat sensitive medications within 30 days of first treatment.
- •Used an investigational drug/device therapy or participated in any clinical investigation relating to pain within 4 weeks prior to study enrollment.
- •A psychiatric or psychological condition that would place undo stress on the subject, prevent full participation or compromise data collection.
- •The subject is otherwise determined, based on the opinion of the Investigator, to be an unsuitable candidate for enrollment in this study
结局指标
主要结局
Compliance with Medical Opioid Use Reduction Protocol
时间窗: 12 weeks
Prescriptions for pain medications will be provided each week. Each successive prescription will have a decreasing quantity of tablets consistent with an agreed upon taper rate. Taper rates will be roughly based upon the recommendations of the CDC (10% per week). Subjects will have the option of postponing the taper by one week as often as every other week. If a subject was to exercise every option available to them to delay taper, then the weaning process would take twice as long and the rate of taper would be cut in half. The study will compare the number of missed medication tapers, and the taper rates of patients in the HIGH POWER LASER treatment periods to those in the LOW LEVEL LASER THERAPY treatment periods.
次要结局
- Self-reported measure of Anxiety.(12 weeks)
- Self-reported measure of Quality of Life.(12 weeks)
- Self-reported measure of Depression.(12 weeks)
- Self-reported measure of Sleep Quality.(12 weeks)
- Urine screening(12 weeks)
- Self-reported measure of Pain.(12 weeks)