Treatment for Foot Pain Caused by Diabetic Neuropathy Using Recurrent TransCutaneous Magnetic Stimulation (TCMS)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 主要终点
- Overall Pain reduction
研究概览
简要总结
The study will evaluate whether an experimental medical device that emits a series of brief, intense magnetic pulse will relieve foot pain from Diabetic Neuropathy (DN) if used weekly for a month
详细描述
The study will evaluate whether an experimental medical device that emits a series of brief, intense magnetic pulse will relieve foot pain from Diabetic Neuropathy (DN) if used weekly for a month The United States Food and Drug Administration (FDA) has approved a similar device for treatment of migraine headaches, but this type of device has not been studied for the treatment of DN. No significant adverse reactions or side effects have been reported from the use of magnetic stimulation for the headache treatment or for the treatment of foot pain for about 20 patients. Some patients who have migraine headaches or foot pain have excellent pain relief with the magnetic treatment even if they did not get pain relief using medications.
The initial safety and feasibility study did show it was both safe and effective but short term with most benefits wearing off after 1 week. Additionally in the initial study no placebo comparisons were made, therefore this study will consist of 20-blinded randomized patients. 10 will receive the TCMS treatment weekly and 10 will receive a sham treatment weekly both for 1 month.
Investigators believe that using the device weekly will relieve the foot pain caused by diabetic neuropathy over the course on 1 month compared with those receiving the sham treatment.
And to prove this hypothesis investigators will treat 10-blinded patients in the TCMS treatment group, they will be receiving active treatment as follows:
50 pulses to the sole of the patient's left (L) foot by placing the foot on top of the device with the heel touching the heel stop (the rear position)
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
20 patients given the choice of 1 out of 20 envelopes they pick, 10 will be randomized to either the real TCMS treatment arm or 10 to the sham treatment arm
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
- •Age ≥ 18 years of age.
- •Pain duration of more than one month.
- •Pain occurs daily.
- •Chronic DN associated bilateral foot pain and is not explained by a central anatomic nerve compression and can clearly be correlated with that patient's history of diabetes.
- •Average Pain intensity ≥ 5 in each foot for at least 3 days at the time of enrollment.
排除标准
- •Life expectancy ≤ 6 months.
- •Oral pain medication doses or active ingredient has changed significantly* in the prior 2 weeks.
- •Inability to walk at least 10 steps (with or without a cane/walker) before and after having to sit in a chair.
- •Another pain condition that might confound results (e.g., neuropathy from cancer chemotherapy, plantar fasciitis or arthritis of ankle and foot)
- •Inability to undergo study assessments or complete questionnaires independently.
- •Active psychological co-morbidities (i.e., uncontrolled schizophrenia).
- •Currently using an opioid medication for the treatment of foot pain**.
- •Inability to have MRI
- •Metal hardware and/or fragments in feet and ankles
- •Implanted pacemaker or a defibrillator, unless the device is considered MRI safe
- •A significant change for this study is defined as a 20% increase or decrease in dosing of the patient's medication dose and/or or a change in the medication class (adding or removing other types of medicines used to treat pain).
- •This exclusion is restricted to opioids, benzodiazepines and psychotropic.
结局指标
主要结局
Overall Pain reduction
时间窗: 28 day +/- 2 days
The primary endpoint will be defined as achieving at least reduction in average pain score from 0-10 (0 being no pain and 10 being the worst pain imaginable) )versus the sham control using pre-study average baseline for each subject as a covariate by a repeated measures analysis of pain scores through 28 days.
次要结局
- Improved Activities of daily living(28 days +/- 2 days)
- Pain reduction with in the first week(1 week)