CLINICAL EFFECT OF BOTULINUM TOXIN TYPE A IN THE TREATMENT OF SPASTICITY AFTER TRAUMATIC BRAIN INJURY, SPINAL CORD INJURY OR IN MULTIPLE SCLEROSIS PATIENTS: AN OBSERVATIONAL STUDY
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Modified Ashworth Scale (MAS)
研究概览
简要总结
Spasticity has been defined as a disorder of the sensorimotor system characterized by a velocity-dependent increase in tonic stretch reflexes (muscle tone) with exaggerated tendon jerks, resulting from hyperexcitability of the stretch reflex.
The treatment goal of spasticity is Medical treatment generally combines physiotherapy with medications, depending on spasticity distribution. Systemic treatments such as oral or intrathecal baclofen are generally considered in case of generalized spasticity, whereas local treatments are considered in case of focal spasticity.
Local treatments such as Botulinum Toxin type A, phenol, and alcohol present several advantages, allowing to treat of selected muscles without the risk of sedation. As stated above, they are indicated for focal spasticity but might be helpful even in the presence of generalized spasticity with identified focal goals (Bethoux et al., 2015).
In particular, Botulinum Toxin type A (BoNT-A) is considered the gold standard treatment for focal spasticity, showing a level A evidence for spasticity reduction in upper- and lower-limb spasticity (Simpson et al., 2016).
However, current evidence is mainly focused on post-stroke spasticity (Franceschini et al., 2014), whereas it is still limited in spasticity as a consequence of other aetiologies, such as spinal cord injury (SCI), traumatic brain injury (TBI), or multiple sclerosis (MS).
Interestingly, spasticity is a major concern for the rehabilitation of these patients.
The aim of this observational study is the evaluation of the clinical efficacy of BoNT-A in spasticity reduction in patients affected by neurological conditions different from post-stroke spasticity, such as SCI, TBI, and MS.
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
- •Age >18 years
- •Spasticity as a consequence of traumatic brain injury, spinal cord injury or MS (documented by clinical records)
- •Muscle tone graded at least 1+ on the modified Ashworth scale in the relevant joints of the affected limb(s), which requires medical intervention
- •BoNT naïve or pre-treated with any BoNT product. If previously treated with any BoNT, at least a 4 months interval between last injection and inclusion
排除标准
- •Presence of fixed contractures or bony deformities in the affected limb
- •Changes in any oral antispastic medications or specific physiotherapy regimen <4m before study entry or during the study.
- •Other neurological or orthopaedic conditions involving the affected limbs.
- •Sensitivity to BoNT-A or to its excipients
- •Other contraindications as given in the local SmPC for BoNT-A
结局指标
主要结局
Modified Ashworth Scale (MAS)
时间窗: 1 month
Percentage of patients with at least 1 point reduction of MAS in any treated muscle, 1 month after BoNT-A injection injection of Botulinum toxin A (responders)
次要结局
- passive range of motion(e, 1, 3 and 6 months or before new BoNT-A injection)
- Numeric Rating Scale for pain(, 1, 3 and 6 months after BoNT-A or before the new BoNT-A injection)
- EQ5-D(1, 3 and 6 months after BoNT-A or before the new BoNT-A injection)
- interval of time between BoNT-A reinjections(3-6 months)
- Global Assessment of Efficacy scale)(1 month and 3 months after boNT-A injection)
- active range of motion(e, 1, 3 and 6 months or before new BoNT-A injection)
研究者
Alessio Baricich
MD PhD
Università degli Studi del Piemonte Orientale "Amedeo Avogadro"