Peripheral Nerve Responses to Focal Vibration and Implications in Pain and Mobility for Patients With Diabetic Peripheral Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Changes in CMAP
研究概览
简要总结
The purpose of this study is to characterize the changes in peripheral nerve functions (sensory and motor) in patients with diabetic peripheral neuropathy, and examine the relations between the changes in nerve functions and changes in pain and mobility using focal vibration.
详细描述
Peripheral nerve impairments are highly prevalent in patients with diabetic peripheral neuropathy (DPN) and are associated with pain and poor mobility. While peripheral sensorimotor nerve function is implicated in neuropathy, the mechanism associated with both pain and mobility is not well understood. Even less understood is the interplay between, and responses to, sensory and motor fibers of the affected peripheral nerve. In our previous study, focal vibration (FV) was effective in reducing pain and improving mobility for only a subgroup of participants with DPN. Because FV stimulates both motor and sensory peripheral nerve fibers, when combined with nerve conduction testing, it offers a unique opportunity to study both the sensory and motor peripheral nerve performance and their contribution to pain and mobility in patients with DPN. We are proposing a single group, repeated measured study to: characterize the changes in sensory and motor peripheral nerve functions; examine the association(s) between these changes and changes in pain and mobility, using FV. If successful, this study will provide us with a better understanding of the role played by sensory and motor nerve impairments in pain and mobility for DPN, and support larger clinical studies to optimize nerve function performance and the FV parameters. We will also explore how changes in the peripheral nerve function associate with severity of DPN.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of diabetes for at least one year;
- •Diabetic peripheral neuropathy as defined by failure to sense the 5.07 (10g) monofilament test in one or more of the six sites tested;
- •Age 45-80 years old;
- •Able to ambulate independently without assistive devices (e.g., walker or crutches) for 30 feet;
- •No evidence of neurological (other than peripheral neuropathy) or orthopedic conditions;
- •Able to understand English instructions;
- •Have normal or corrected vision.
排除标准
- •With other non-diabetic causes of neuropathy by history;
- •Symptomatic peripheral vascular disease, joint pain, swelling and/or limited range of motion in the lower extremities that interfere with walking;
- •Other systemic or local diseases that could interfere with walking assessment
- •Amputation in the lower extremities;
- •Clinically diagnosed with dementia greater than mild (screened using Montreal Cognitive Assessment (MOCA) <24)
结局指标
主要结局
Changes in CMAP
时间窗: Change from Baseline CMAP measures every 2 weeks for up to 6 weeks
The peroneal compound muscle action potential (CMAP)
Changes in TUG
时间窗: Change from Baseline TUG scores every 2 weeks for up to 6 weeks
Timed Up and Go (TUG) test
Changes in NTSS-6
时间窗: Change from Baseline NTSS-6 scores every 2 weeks for up to 6 weeks
The Neuropathy Total Symptom Score - 6-items (NTSS-6), which quantifies frequency and intensity of aching, burning, prickling and lancinating pain, numbness, and allodynia in patients' feet and legs.
Changes in NSS
时间窗: Change from Baseline NSS scores every 2 weeks for up to 6 weeks
The Neuropathy Symptom Score (NSS), which quantifies symptoms of motor, sensory, and autonomic deficits.
Changes in BPI-DPN
时间窗: Change from Baseline BPI-DPN scores every 2 weeks for up to 6 weeks
The Brief Pain Inventory Short Form for Diabetic Peripheral Neuropathy
Changes in NIS
时间窗: Change from Baseline NIS scores every 2 weeks for up to 6 weeks
The Neurologic Impairment Score (NIS), composed of a sensory sub-score (which evaluates sensory perceptions to touch, prickling pain, vibration, joint position, and 1- and 10-g monofilaments in the upper and lower extremities) and a motor sub-score (which evaluates cranial nerves, muscle strength, muscle wasting, and deep tendon reflexes in the upper and lower extremities).
Changes in NCV
时间窗: Change from Baseline NCV measures every 2 weeks for up to 6 weeks
The peroneal motor nerve conduction velocity
Changes in SNAP
时间窗: Change from Baseline SNAP measures every 2 weeks for up to 6 weeks
The digital sensory nerve action potentials
次要结局
未报告次要终点