NCT00447876已完成2 期
Double-blind, Placebo-controlled, Randomised, Multicentre Study on the Efficacy and Safety of a Single Injection of Botulinum Toxin A (200 Units Dysport®) in the Treatment of Chronic Plantar Fasciitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 40
- 试验地点
- 5
- 主要终点
- Responders Rate at Week 6 (Pain While Moving)
研究概览
简要总结
This study will investigate the hypothesis that the analgesic effect of a single injection of Dysport (200 MU) induces a significant reduction of symptoms in chronic cases of plantar fasciitis.
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
- Double (Participant, Investigator)
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
- •Chronic plantar fasciitis (duration of disorder at least 4 months)
- •At least 4 points on the visual analogue scale (0-10) for the most severe pain within the last 48 hours
- •At least 2 previous unsuccessful conservative therapies
- •Age 18 and older
排除标准
- •Rheumatoid diseases (M. Bechterew, chronic polyarthritis, psoriasis-arthritis, para /post-infectious arthritis etc.)
- •Previous surgery in the affected area of the foot
- •Pre-treatment with Botulinum toxin A (only de novo patients)
- •Prohibited concomitant treatment: local injections during the study and 2 weeks prior to start of study
研究组 & 干预措施
Botulinum type A toxin (Dysport®)
Experimental
干预措施: Botulinum toxin type A (Biological)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Responders Rate at Week 6 (Pain While Moving)
时间窗: Baseline and Week 6
The responder rate was defined as the percentage of patients whose pain score while moving during the last 48 hours, measured by means of a 10 cm Visual Analogue Scale (VAS, 0 = no pain, 10 = maximum pain) decreased by at least 50% at Week 6 as compared to baseline. Pain at movement is the cardinal symptom of plantar fasciitis and the 10 cm VAS is a reference method for the assessment of pain intensity.
次要结局
- Assessment of Sum of Pain Intensity Difference (SPID) for Maximum Pain for Overall Study(Baseline and Weeks 2, 6, 10, 14 and 18)
- Assessment of SPID for Continuous Pain for Overall Study(Baseline and Weeks 2, 6, 10, 14 and 18)
- Changes From Baseline in Continuous Pain (Pain At Rest) at Each Visit(Baseline and Weeks 2, 6, 10, 14 and 18)
- Changes From Baseline in Pressure Threshold (With Algometer) at Each Visit(Baseline and Weeks 2, 6, 10, 14 and 18)
- Assessment of Sum of Pressure Threshold Differences (by Measurement of AUC) for Overall Study(Baseline and Weeks 2, 6, 10, 14 and 18)
- Changes From Baseline in Pain Threshold at Each Visit(Baseline and Weeks 2, 6, 10, 14 and 18)
- Assessment of Dorsal Extension / Plantar Flexion Range of Motion (ROM) of the Affected Foot At Week 18(Baseline and Week 18)
- Changes From Baseline in Gerbershagen's Score at Week 18(Baseline and Week 18)
- Changes From Baseline in Maximum Pain (Pain While Moving) at Each Visit(Baseline and Weeks 2, 6, 10, 14 and 18)
- Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit(Baseline and Weeks 2, 6, 10, 14 and 18)
- Assessment of Sum of Pain Threshold Differences (by Measurement of AUC) for Overall Study(Baseline and Weeks 2, 6, 10, 14 and 18)
- Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit(Baseline and Weeks 2, 6, 10, 14 and 18)
研究者
研究点 (5)
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