Quantitative Assessment of Painful Diabetic Peripheral Neuropathy After High Frequency Spinal Cord Stimulation: (QUANT) HF10 Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Positive Pain
研究概览
简要总结
Will participants with painful lower extremity diabetic peripheral neuropathy (DPN) that are treated with high frequency spinal cord stimulation (HF10 SCS) have improvements in lower extremity peripheral nerve function?
详细描述
This research study is being conducted to find out if spinal cord stimulation (SCS) can improve nerve function. SCS is FDA approved for the treatment of intractable neuropathic (nerve) pain related to diabetic peripheral neuropathy. With SCS a wire is placed in the epidural space and the spinal cord is stimulated to interrupt the pain signal coming from the legs. The spinal cord stimulator is a device similar to a pacemaker (which helps treat abnormal rhythms of the heart). Recent studies have suggested that SCS with high frequencies can improve nerve function for subjects with painful peripheral neuropathy therefore, the investigators are looking to measure changes in nerve function after SCS for treatment of painful diabetic peripheral neuropathy.
The purpose of this research is to gather information on the effect of high frequency spinal cord stimulation (HF10) on nerve function with a spinal cord stimulator.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes mellitus
- •Refractory predominantly lower extremity neuropathic pain for > 1 year
- •Presence of length dependent peripheral neuropathy on sudomotor testing
- •Completed spinal cord stimulation trial with 40% or greater pain reduction from baseline
- •Failed medication trials or contraindication to gabapentin medications (gabapentin, pregabalin) and/or serotonin/norepinephrine reuptake inhibitors (tricyclic antidepressant (TCA) or duloxetine or venlafaxine)
- •Average pain score on a visual analog scale (VAS) of ≥ 5 (with 0 representing no pain and 10 the worst pain imaginable)
- •Appropriate surgical candidate for spinal cord stimulator
排除标准
- •Severe Autonomic Neuropathy as measured by the composite autonomic scoring scale (10 point scale) with a score ≥ 7
- •History of sympathectomy
- •Uncontrolled arterial hypertension (Systolic Blood Pressure >160)
- •Baseline Foot TcPO2 < 10 mmHg to exclude patients with severe peripheral arterial disease
- •Hemoglobin A1c > 8%
- •Stable opioid regimen with oral morphine equivalent ≥ 100 mg/day
- •Alternative principle cause for peripheral neuropathy or lower extremity neuropathic pain
- •Disruptive psychiatric disorder (screened for during preoperative psychiatric evaluation)
- •Pending litigations
- •Women of child bearing potential unwilling to use contraception or found to be pregnant as part of perioperative screening
- •Patients unable to hold medications that would impact autonomic testing
结局指标
主要结局
Positive Pain
时间窗: baseline, 12 months
Numeric Rating Scale used to assess pain from a scale of 0 (no pain) to 10 (worst possible pain)
Pain Assessment
时间窗: Baseline, 12 months
Pain measurement using a Visual Analog Pain Scale by placing an X in the box to indicate the severity of pain from no pain to intolerable pain. The X in the box translates to a score of zero for no pain and increases by an additional 0.5 up to a high score of 10 which would be intolerable pain.
Neuropathy Impairment Score (NIS)
时间窗: Baseline, 12 months
Subject's scores neuropathic deficits using a scale of 0-4 (zero=normal, 4=paralysis) to measure muscle weakness. The NIS score is a measure of neurologic impairment. The NIS Score has a range of 0 to 244. Lower scores indicate higher function, higher scores indicate lower function.
Modified Leads Assessment of Neuropathic Symptoms and Signs
时间窗: baseline, 12 months
Questionnaire to identify and analyze pain by answering yes/no which translates to scores from 0-24. A score of 12 or more suggests pain of predominantly neuropathic origin.
Neuropathy Symptoms and Change (NSC) Score
时间窗: baseline, 12 months
Validated questionnaire that evaluates change in neuropathy symptoms, including symptoms of weakness, sensory symptoms, and autonomic symptoms. Answers to questionnaire are yes/no and if yes, then degree of severity is evaluated with a plus one(slight), plus two (moderate) and plus three (severe). Questionnaire screens the presence and severity of diabetic peripheral neuropathy. Change in severity of symptoms are compared over time. Total scores range from 0 - 114, lower scores reflect no neuropathy symptoms, higher scores reflect more neuropathy symptoms.
Oswestry Disability Index
时间窗: Baseline, 12 months
Questionnaire examines perceived level of disability in 10 everyday activities of daily living including pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life and traveling. The 6 statements are scored from 0 to 5 scale, zero meaning no disability. The final score ranges from 0-100 with a score of 0-20 equals minimal disability, 21-40 equals moderate disability, 41-60 equals severe disability, 61-80 equals crippled and 81-100 equals bed-bound.
Lower Limb Function Test
时间窗: Baseline, 12 months
Test for lower limb function in which the subject will need to walk on toes, walk on heels, and arise from kneeled position, each test is marked as not applicable, normal or abnormal. The examination assesses each component for the left and right side separately. If the test is normal, it is given a score of 0, and if it is abnormal, a score of 1. Not applicable scores a zero. Total scores range 0-6. Therefore, the maximum score of 6 indicates abnormality in all 3 components bilaterally and a minimum score of 0 indicates a normal result for all 3 components bilaterally.
次要结局
- Body Mass Index (BMI)(Baseline, 12 months)
- Hemoglobin A1c(Baseline, 12 months)
- Forearm Sweat Volume Quantitative Axon Reflex Sweat Test (Q-SWEAT)(baseline, 12 months)
- Height(Baseline, 12 months)
- Weight(Baseline, 12 months)
- Patient Health Questionnaire(Baseline, 12 months)
- Proximal Leg Laser Doppler Flowmetry (LDF)(Baseline, 12 months)
- Extensor Digitorum Brevis Muscle Nerve Conduction(Baseline, 12 months)
研究者
Narayan R. Kissoon
Principal Investigator
Mayo Clinic