Comparison Between Palpatory and Ultrasound-guided Methods for Botulinum Toxin Administration in Spastic Paraplegia
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in spasticity after BoNT-A injection techniques
研究概览
简要总结
Spasticity in spastic paraplegia is a major cause of chronic pain and functional limitation. Although botulinum toxin type A (BoNT-A) reduces muscle tone, studies like the SPASTOX trial have shown limited functional improvement, which may be related to injection accuracy in deep or complex muscle groups. Ultrasound guidance enhances injection precision, potentially improving clinical outcomes. This prospective, single-group, fixed-sequence crossover study ($N = 40$) aims to compare the response to BoNT-A in patients with spastic paraplegia (all etiologies included). Participants will receive treatment in two distinct phases separated by a 16-week washout period: first with conventional anatomical landmark-guided injections, followed by ultrasound-guided injections. A fixed sequence (anatomical first, ultrasound second) is used to prevent observer bias, ensuring the injector remains blinded to muscle ultrasound features (e.g., fatty infiltration or fibrosis) during the landmark-guided phase. Both the participants and the outcome assessor are blinded to the application sequence. Assessments will occur before and 4 weeks after each intervention using validated tools, including the Modified Ashworth Scale, Goal Attainment Scaling (GAS), Timed Up and Go (TUG), Visual Analog Scale (VAS) for pain, modified Barthel Index, SF-36 questionnaire, and the Heckmatt scale. The hypothesis is that ultrasound-guided injections will achieve greater spasticity reduction and functional recovery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Although classified as Open Label in the study structure because all participants follow a single fixed sequence, participants and outcome assessors are strictly blinded to the intervention phase to minimize evaluation bias.
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 over 18 years
- •Clinical diagnosis of spastic paraplegia
- •Spasticity with Ashworth Scale score between 2 and 3 in at least one muscle group with indication for botulinum toxin treatment
- •Muscle strength ≥ 3 on the Muscle Strength Assessment Scale
- •Enrollment in a rehabilitation program
- •For women of childbearing potential, a negative beta-hCG test at the time of injection
排除标准
- •Concomitant neuromuscular disorders
- •History of hypersensitivity to botulinum toxin
- •Active infection at the injection site
- •Ashworth Scale score of 4
- •Pregnancy or breastfeeding
研究组 & 干预措施
Spastic Paraplegia Cohort (Anatomical Toxin Injection followed by USG-Guided Injection)
Participants with spastic paraplegia receive two sequential treatments separated by a 16-week washout period:
First intervention: AbobotulinumtoxinA injection using the conventional anatomical/palpation technique.
Washout period: 16 weeks. Second intervention: AbobotulinumtoxinA injection using the ultrasound-guided technique
干预措施: AbobotulinumtoxinA - Ultrasound-Guided Technique (Drug)
Spastic Paraplegia Cohort (Anatomical Toxin Injection followed by USG-Guided Injection)
Participants with spastic paraplegia receive two sequential treatments separated by a 16-week washout period:
First intervention: AbobotulinumtoxinA injection using the conventional anatomical/palpation technique.
Washout period: 16 weeks. Second intervention: AbobotulinumtoxinA injection using the ultrasound-guided technique
干预措施: AbobotulinumtoxinA - Conventional Technique (Drug)
结局指标
主要结局
Change in spasticity after BoNT-A injection techniques
时间窗: Baseline and 4 weeks after each injection session
Change in spasticity measured by the Modified Ashworth Scale (MAS), comparing conventional landmark-guided versus ultrasound-guided botulinum toxin type A injections in patients with spastic paraplegia. The Modified Ashworth Scale ranges from 0 to 4, with higher scores indicating greater muscle tone/spasticity (worse outcome)
Functional improvement assessed by Goal Attainment Scaling
时间窗: Baseline and 4 weeks after each intervention
Functional improvement assessed by Goal Attainment Scaling (GAS) after conventional landmark-guided versus ultrasound-guided botulinum toxin type A injections. The Goal Attainment Scaling score ranges from -2 to +2, with higher scores indicating greater achievement of the predefined treatment goals (better outcome)
Functional mobility assessed by the Timed Up and Go Test
时间窗: Baseline and 4 weeks after each intervention
Change in functional mobility measured by the Timed Up and Go (TUG) Test, comparing conventional landmark-guided versus ultrasound-guided botulinum toxin type A injections. The Timed Up and Go Test is measured in seconds, with lower times indicating better functional mobility (better outcome)
Change in functional independence assessed by the Modified Barthel Index
时间窗: Baseline and 4 weeks after each intervention
Change in functional independence measured by the Modified Barthel Index, comparing conventional landmark-guided versus ultrasound-guided botulinum toxin type A injections. The Modified Barthel Index ranges from 0 to 100, with higher scores indicating greater functional independence (better outcome).
次要结局
- Pain intensity after BoNT-A injection techniques(Baseline and 4 weeks after each intervention)
- Quality of life after BoNT-A injection techniques(Baseline and 4 weeks after each intervention)
- Adverse events related to BoNT-A injection techniques(Up to 16 weeks after each injection)