A Phase III, Double Blind, Randomized, Placebo-controlled Study to Assess the Efficacy of Adjunct Monochromatic Near-infrared Photoenergy (MIRE) in Patients With Painful Axonal Peripheral Neuropathy
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Percentage of Subjects That Have a Greater Than or Equal to Forty Percent Decrease on the Visual Analog Pain Scale at the End of Four Weeks of Treatment
研究概览
简要总结
The purpose of this study is to determine if near infrared light therapy is effective in decreasing pain in patients with painful peripheral neuropathy. The hypothesis of the study was that the percentage of subjects with at least 40% improvement in visual analog scale score for pain after 4 weeks of treatment is higher for Monochromatic Near-infrared Photoenergy (MIRE) treatment than for sham treatment.
详细描述
Pain is a very common symptom, between 65-80%, in patients with peripheral neuropathy. This study is designed to evaluate the effectiveness of monochromatic near infrared photoenergy therapy (MIRE) in the treatment of pain in axonal peripheral neuropathy. This will be compared with a placebo (sham) device.
The MIRE is a FDA approved, drug-free, non-invasive, medical therapeutic device that uses near-infrared light emitting diodes to deliver monochromatic near infrared photoenergy (MIRE) through contact with the skin. The effect of MIRE is believed to increase local blood circulation by dilating vessels and to reduce pain by decreasing local swelling and inflammation. MIRE is also thought to increase local levels of nitric oxide (NO) which may decrease pain levels.
Study subjects will receive treatment with the device or the placebo device 3 times per week for 4 weeks. Response will be measured during and after the treatment period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ages 18-85; able to give informed consent
- •Documented painful, distal peripheral neuropathy of idiopathic cause, or related to impaired glucose tolerance or diabetes mellitus.
- •Neuropathy documented by one of the following studies: nerve conduction studies and needle electromyography (EMG); quantitative sensory testing of the foot with Computer Aided Sensory Evaluator (CASE IV); quantitative sudomotor axon reflex test (Quantitative Sweat MeasurementSystem [Q-Sweat]); neurology specialty examination; and neuropathy impairment score (NIS) of less than
- •Stable pharmacotherapy for neuropathic pain for at least two weeks.
- •Optimal pharmacotherapy has been achieved.
- •Subjects cannot be on Cyclooxygenase-2 (COX 2) inhibitors
- •Pain Visual Analog Scale (VAS) of greater than or equal to 4/10
- •Subject has provided written informed consent
- •Not currently using transcutaneous electrical nerve stimulation (TENS)
- •Not currently receiving acupuncture
排除标准
- •Pregnant or likely to become pregnant
- •Current diagnosis of cancer
- •Neuropathy impairment score (NIS) of greater than
- •Diagnosis of severe neuropathy of known etiology for which specific treatment is available (i.e., acute and chronic inflammatory polyradiculoneuropathies, vasculitis, B 12 deficiency).
- •Unstable diabetes mellitus defined as a hemoglobin A1c (HbA1c) greater than 9%, and/or 10% of fasting blood sugars greater than 300 mg/dl for the week prior to enrollment.
结局指标
主要结局
Percentage of Subjects That Have a Greater Than or Equal to Forty Percent Decrease on the Visual Analog Pain Scale at the End of Four Weeks of Treatment
时间窗: baseline, 4 weeks
Pain was measured by a 10 cm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes. On this scale 0 means no pain and 10 cm means extreme pain. The investigator measures the mark made by the subject in cm and records this for the value of pain.
次要结局
- Percentage of Subjects That Have a Forty Percent Reduction of Pain Measured by the Neuropathic Pain Scale at the End of Four Weeks of Treatment(baseline, 4 weeks)
- Percentage of Subjects That Have an Improvement of Two Points or More on the SF-8 at the End of Four Weeks of Treatment(baseline, 4 weeks)