The Effect of Intraneural Facilitation Therapy on Diabetic Patients With Peripheral Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Pain Quality Assessment Scale
研究概览
简要总结
The purpose of this graduate student research study is to explore the effects of a new treatment known as Intraneural facilitation (INF) on Diabetes Mellitus Type 2 (DMT2) subjects who have moderate - severe below ankle neuropathy symptoms. Since INF has shown success in the clinic and significant improvements have been found in a recent pilot study, this study aims to further explore these effects on DMT2 subjects suffering from DPN. The investigators would like to investigate if INF improves blood flow in the foot, if it decreases the pain and improves the sensation, and if it improves the overall quality of life.
详细描述
The demographic data (age, height, gender, and weight) will be collected from each subject. All subjects will go through the following protocol: First, subjects will complete pre-testing measurements consisting of 5 tests; Pain Quality Assessment Scale, Semmes-Weinstein Monofilaments, NeuroCom SMART Balance Master, Quality of Life- Diabetic Neuropathy Scale (QOL- DN), and Zeno Walkway. Patients will then be randomized into two groups and blinded by the treatment. Patients who draw "Group 1" will be given the INF treatment and patients who draw "Group 2" will be given the SHAM treatment. Patients will then be completing 3 weeks of INF treatment, or SHAM treatment for 3 visits per 3 week, totaling 9 treatment visits. Post treatment, patients will then return for the same 5 measurements completed at baseline.
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
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Diabetes Type 2 and Diabetic Peripheral Neuropathy with no other known underlying disease
- •Below ankle Diabetic Peripheral Neuropathy symptoms (numbness, tingling, burning, sharp pain, increased sensitivity, etc.)
- •≥10 on Quality of Life- Diabetic Neuropathy Scale (QOL- DN)
- •Between age 50-75 years
排除标准
- •Patients with a medical condition that suggested possible decline in function over the next 6 months such as; a current regimen of chemotherapy, radiation therapy, or dialysis
- •Any lower extremity amputations or wounds
- •Documented active alcohol and/or drug misuse
- •Known health conditions: end stage renal failure, uncontrolled hypertension, severe dyslipidemia, chronic liver disease, autoimmune disease, advanced chronic obstructive pulmonary disease and active inflammations
- •DM patients with inflammatory neuropathies including chronic inflammatory demyelinating polyneuropathy (CIDP), proximal diabetes neuropathy, and autonomic neuropathies
- •Patients with other types of neuropathies not associated with Diabetes Mellitus such as B12 deficiency, hypothyroidism, and uremia
- •Other severe chronic medical condition requiring active treatment
- •Morbidly Obese patients
- •Pregnancy (self reported)
结局指标
主要结局
Pain Quality Assessment Scale
时间窗: change between baseline and 5 weeks
It is a self-report tool derived from Neuropathic Pain Scale to evaluate the quality of neuropathic pain. After reading the introduction of the questionnaire, subjects will then measure their pain on a numeric scale 0= "no pain" or "no painful sensation" to 10 = "worst imaginable pain sensation" . A zero score represents the best outcome and a 10 is the worst outcome. This questionnaire takes approximately 10 minutes.
次要结局
- Zeno Walkway(change between baseline and 5 weeks)
- Sensory organization test (SOT)(change between baseline and 5 weeks)
- Limits of Stability(change between baseline and 5 weeks)
研究者
Lee Berk
Professor
Loma Linda University