NCT05296642撤回不适用
Exploring the Use of Blood Flow Restriction in Addition to Aerobic Exercise as a Modality to Produce Exercise Induced Hypoalgesia in Participants With Painful Diabetic Peripheral Neuropathy.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Change in Pain Pressure Threshold (PPT)
研究概览
简要总结
The purpose of this research study is to learn whether different forms of exercise can reduce pain experienced by individuals with painful diabetic peripheral neuropathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects between the ages of 18 -
- •Subjects with confirmed Diabetes Mellitus as defined by the American Diabetes Association (ADA), a glycosylated hemoglobin (HbA1c) of 6.5%, a fasting blood glucose > 126 mg/dL, or an oral glucose tolerance test > 200 mg/dL.
- •Subjects who have stocking and/or glove distribution neuropathy symptoms as drawn on the painDETECT questionnaire.
- •Subjects who have neuropathic pain as defined by a minimum score of 4 or higher on the Douleur Neuropathique en 4 Questions (DN4). In addition, the location of pain must be present within the same region of neuropathy symptoms.
- •Subjects who have an ankle brachial index (ABI) between 0.7 and 1.4.
排除标准
- •Subjects who have pain due to some other form of neuropathy (chemo-induced neuropathy, alcohol induced neuropathy, exposure to toxins/chemicals, vitamin b12 deficiency, etc.) assessed via a medical history.
- •Subjects with current or history of central nervous system disorders.
- •Subjects with resting hypertension (HTN) >/= 160/90 mmHg or known uncontrolled hypertension, coronary artery disease, heart failure, retinopathy, chronic obstructive pulmonary disease, end-stage renal disease, or current open foot ulcers.
- •Subjects who are unable to achieve walking a minimum distance of 400 meters in the six-minute walk test.
- •Subjects with Reynaud's disease or cold urticaria.
- •All vulnerable populations including adults unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant women, prisoners, individuals with cognitive impairment.
结局指标
主要结局
Change in Pain Pressure Threshold (PPT)
时间窗: Baseline, 20 minutes
PPT will be measured both locally at the quadriceps and distally at the upper trapezius. The PPT will be determined with three series of ascending stimulus intensities at each point over 3 rounds. A positive change in PPT (PPT following exercise subtracted from PPT before exercise) will demonstrate an intact exercise induced hypoalgesic response.
次要结局
- Change in Heat Pain Threshold (HPT)(Baseline, 20 minutes)
研究者
Marlon Wong
Assistant Professor
University of Miami
研究点 (2)
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