A Prospective, Observational Study to Assess Pain Relief After 4 Botulinum Toxin Type A (BoNT-A) Injection Cycles in Patients With Post-stroke Lower Limb Spasticity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 186
- 试验地点
- 28
- 主要终点
- Change in Pain relief on Numeric Rating Scale
研究概览
简要总结
The objective of this study is to demonstrate the effect of intramuscular BoNT-A injections in relieving pain, in a broad population of patients who suffer pain as the primary problem associated with spasticity. Thus, this study will help to expand the information that is available regarding the impact of BoNT-A treatment in routine clinical practice conditions.
Treatment goals can vary greatly from one patient to another and there is no unique, single outcome that reflects the treatment benefits in all the cases. Therefore, this study with special focus on the achievement of therapeutic goals, will allow the identification of each patient's specific goals regarding the improvement of the functional outcomes, the quality of life and patient well-being.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Men or women age 18 years and above
- •Post-stroke lower-limb spasticity
- •Prior agreement with the patient to inject BoNT-A
- •If previously treated with BoNT-A, (at least 3 months interval between last injection and inclusion).
- •Therapeutic goals agreed jointly with the patient
- •Functional Ambulation Classification (FAC) score 2-5
- •Capacity to comply with the protocol
- •Written informed consent
排除标准
- •Documented positive antigenicity to botulinum toxin
- •Neuromuscular disease
- •Use of medications that interfere with neuromuscular transmission
- •Severe muscle atrophy in any muscle to be injected
- •Any other indication that might interfere with rehabilitation or the evaluation of results
- •Any non-stroke spasticity diagnosis
- •Pregnancy or nursing mothers
- •Previous participation in any study using Goal Attainment Scale (GAS)
结局指标
主要结局
Change in Pain relief on Numeric Rating Scale
时间窗: Baseline visit and every 4 months up to 16 months (Visit 5).
Pain relief evaluated by Numeric Rating Scale (NRS). The NRS score for patient self-reporting of pain ranging from 0 (no pain) to 10 (the most severe pain).
次要结局
- Responder rate using goal Attainment Scale(Every 4 months up to 16 months (Visit 5).)
- Change in Pain relief on Visual Assessment Scale(Baseline visit and every 4 months up to 16 months (Visit 5).)