A Randomized, Double-blind, Placebo-Controlled, Cross-over Study on the Effect of Pregabalin on Pain Related to Walking in Patients With Diabetic Peripheral Neuropathy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Decrease in fall risk associated with walking assessed with the Physiological Profile Assesment
研究概览
简要总结
The hypothesis of this study is that pregabalin, 150 mg bid, will reduce general daytime pain in patients diagnosed with diabetic peripheral neuropathy and that it will also reduce the level of pain associated with walking. Consequently, it is hypothesized that the reduction in pain will result in an increase in the amount of walking they do during the day, improvements in their gait, balance, risk of falls and sleep patterns.
详细描述
Pregabalin (LYRICA®) is a potent and specific ligand at the alpha-2-delta subunit of voltage-gated calcium channels. It is currently approved for adjunctive therapy for neuropathic pain conditions. Patients with diabetic peripheral neuropathy suffer from pain in their feet which interferes with their ability to walk which includes less walking, an altered gait, and altered balance. At night the peripheral neuropathy also interferes with their sleep patterns.The hypothesis of this study is that pregabalin, 150 mg bid, will reduce general daytime pain in patients diagnosed with diabetic peripheral neuropathy and that it will also reduce the level of pain associated with walking. Consequently, it is hypothesized that the reduction in pain will result in an increase in the amount of walking they do during the day, improvements in their gait, balance, risk of falls and sleep patterns.Pain and sleep quality will be assessed with questionnaires but objective measurements will be used to assess gait, balance, daytime activities (including walking) and sleep patterns.
Statistical Power Calculations were based on the fact that this is a randomized, double-blind, placebo-controlled, 2-period crossover study to be conducted at a single site. Comparisons will be drawn at baseline, at the completion of each 6 weeks of treatment/placebo arm. The study has been powered at 0.80 for a two-tail analysis with a sensitivity to detect a 30% delta in pain perception in 40 subjects. From previous studies, the cross-over design suggested has achieved significance with 20 patients per group. Forty-four patients will be recruited in total. Significance will be established at an alpha level of 0.05. Both parametric and non parametric correlations will be carried out between the different variables measured and progressive logistic regression to determine the relative contributions of pain relief on the primary and secondary variables being measured in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals with painful, peripheral neuropathy (ages 40-75 years) and type 2 diabetes (n=40).
排除标准
- •Active ocular or systemic disease
- •Recent or recurrent history of musculoskeletal injury,
- •Presence of neurological conditions or idiopathic neuropathy
- •History of or vertigo
- •Use of an aid while walking or difficulty with standing upright
- •Visible tremor or uncorrected visual deficits.
- •Presence of type 1 diabetes mellitus (defined as C-peptide < 1 ng/ml or diabetes onset at < 35 years of age in a non-obese patient).
- •Presence of diabetic retinopathy that is more severe than "background" level.
- •Presence of diabetic nephropathy
- •Presence of clinically significant neuropathy that is clearly of non-diabetic origin, e.g. alcoholic or autoimmune.
- •Bilateral amputation of lower extremities or foot ulcers involving the great toes.
- •Presence of neuroarthropathy (Charcot deformity) is allowable.
- •History of major macrovascular events such as myocardial infarction or stroke within the past 6 months.
- •Patients with moderate or severe hepatic insufficiency or abnormalities of liver function.
- •Presence of significant pedal edema.
- •Other serious medical conditions that in the opinion of the investigator, would compromise the subject's participation in the study.
研究组 & 干预措施
pregabalin at 150 mg bid
Each subject was randomized to the treatment for 6 weeks, followed by a 2 week washout period, and then completed the other arm of the study.
干预措施: Pregabalin (Drug)
Placebo
Each subject was randomized to the treatment for 6 weeks, followed by a 2 week washout period, and then completed the other arm of the study.
干预措施: Placebo (Drug)
结局指标
主要结局
Decrease in fall risk associated with walking assessed with the Physiological Profile Assesment
时间窗: Up to 6 months
The falls risk will also be ascertained using the long-form Physiological Profile Assessment. The Physiological Profile Assessment has been validated in prospective studies of falls in both community and institutional settings, and predicts those at increased risk of falling with 75-79% accuracy. The Physiological Profile Assessment includes tests of vision (edge contrast sensitivity, high/low contrast visual acuity, depth perception), sensation (ankle touch sensitivity, leg proprioception), leg muscle strength (knee flexion, knee extensors, ankle dorsiflexion), postural sway and postural coordination. Scores from each of these physiologic tests are combined to provide an overall fall risk score that ranges from -2 (very low risk) to +4 (very marked risk).
次要结局
- Patient-assessed change in pain intensity assessed with an 11-point scale(Up to 6 months)
- Patient Global Impression of Change (PGIC)(Up to 6 months)
- Sleep quality assessed with the Medical Outcomes Study Sleep Scale questionnaire(Up to 6 months)
研究者
Aaron I. Vinik, MD, PhD
Director of Research & Neuroendocrine Unit
Eastern Virginia Medical School