Botulinum Toxin for Muscle Cramps in Diabetic Patients With Diabetic Neuropathy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 主要终点
- pain intensity on a 0-10 severity scale
研究概览
简要总结
Objective: previous studies suggest that botulinum toxin A (BoNT/A) can reduce muscle hyperactivity.
Research Design and Methods: a single-center, double-blind and placebo-controlled study investigating the efficacy and safety of BoNT/A intramuscular injection for treating calf or foot cramps refractory to common pharmacological drugs in patients with diabetic peripheral neuropathy. Fifty patients were subdivided in two matched groups (cases and controls) and BoNT/A (100 or 30 units) was injected for each side into the gastrocnemious or the small flexor foot muscles, respectively, according to the predominance of leg or foot cramps. Responders were evaluated again with a second BoNT/A administration.
The changes of pain intensity (primary outcome) and the changes in cramp frequency, the and the Cramp Severity Scale (CSS) were evaluated over the course of 20 weeks after BoNT/A administration.
详细描述
This was a single-center, randomized, double-blind, placebo-controlled prospective study.
A consecutive series of 303 out-patients with type 2 diabetes was screened for muscle cramps.Patients were asked to report in a questionnaire the frequency, localization, intensity and time of the day of cramps. Out of these 303 diabetic patients with cramps, fifty patients satisfied the inclusion/exclusion criteria and entered the study.
Cramp Evaluation
a) Clinical evaluation All patients completed a baseline diary in the week before treatment. Every day the number of muscle cramp episodes was reported three times a day and the intensity of pain was rated on a scale 0 to 10, with 0 indicating no pain and 10 indicating "the worst pain imaginable" (Brief Pain Inventory-Modified Short Form, BPI-MSF, point 1). Daily data in this pre-treatment week were averaged and considered "basal" values. A similar daily diary, reporting the number of pain episodes, their intensity, time of the day and duration (less or more than 1 min) was kept throughout the study for the three days before each control visit.
The severity of cramps interference on daily life was graded according to the functional scale Cramp Severity Score (CSS): 0= no cramps; 1= occasional day or night cramps not interfering with daily activities or with nocturnal sleep; 2= frequent muscle cramps triggered by muscle exercise not significantly interfering with daily activity or with nocturnal sleep; 3= continuous or subcontinuous muscle cramps limiting daily activities or nocturnal sleep; 4= continuous cramps severely interfering with daily activities and nocturnal sleep (4).
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)
盲法说明
double-blind
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •accepting to participate to the study;
- •age ≥ 45 and ≤ 75 years ;
- •diabetes duration > 5 years and diabetic distal symmetric neuropathy present;
- •stable glycemic control with last HbA1c value <9.0% (or 75 mmol/mol);
- •cramps present at rest in either calf or foot muscles or both for at least 6 months;
- •occurrence of cramps at least 3 times a week in the previous three months;
- •previous unsuccessful or poorly tolerated pharmacological treatment with at least two of the following drugs: carbamazepine, quinine, phenytoin, magnesium supplements, and benzodiazepines.
排除标准
- •the presence of other neurological diseases and of nephropathy, macro-angiopathy, cirrhosis, and lumbar disc diseases or the inability to give informed consent because of cognitive impairment.
- •Patients previously treated with BoNT/A for any reason were also excluded
研究组 & 干预措施
botulinum toxin type A
Botulinum toxin type A (100 or 30 units) was injected for each side into the gastrocnemious or the small flexor foot muscles, respectively, according to the predominance of leg or foot cramps.
干预措施: Botulinum toxin type A (Drug)
Normal saline
The same dosage as the active group, but with normal saline alone were injected into the gastrocnemious or the small flexor foot muscles, respectively, according to the predominance of leg or foot cramps.
干预措施: Normal saline (Other)
结局指标
主要结局
pain intensity on a 0-10 severity scale
时间窗: 20 weeks
the intensity of pain was rated on a scale 0 to 10, with 0 indicating no pain and 10 indicating "the worst pain imaginable"
次要结局
- cramp frequency(20 weeks)
- the Cramp Threshold Frequency (CTF)(20 weeks)
- the Cramp Severity Scale (CSS)(20 weeks)
研究者
Domenico Antonio Restivo
Dr
Presidio Ospedaliero Garibaldi-Centro