Incobotulinumtoxin A and Yoga-like Isometric Exercise in Adolescent Idiopathic Lumbar Scoliosis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Reduction in lumbar and thoracic scoliotic curve
研究概览
简要总结
The study uses a yoga-like isometric posture and botulinum injections to reduce the curves in adolescent idiopathic lumbar scoliosis. Three previous studies show that the yoga pose is effective for reversing scoliotic curves; Botulinum toxin has been approved by the FDA for teenagers. However, no studies using the two of them together have been done until this one.
详细描述
The randomized control 6-month study employs an isometric yoga-like posture to strengthen the weak side, and one set of botulinum injections to weaken the strong side of adolescent idiopathic lumbar scoliosis between 25 and 60 degrees. It is open to people between 12 and 18 years of age who are willing to do the pose every day for three months.
This is a crossover study: After 3 months, every patient who was placebo will be offered the actual proven yoga pose and botulinum toxin injections. Two additional free X-rays at 3 weeks and 3 months following the botulinum injection will also be available to each placebo patient.
In this way every patient - placebo or not - will receive the full proper treatment within 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants will understand they may receive placebo, and that they will not be told Investigators will know whether they give injections or not, but will not know if injection is placebo.
Outcomes assessors will be blinded to the entire procedure (radiologists reading X-rays).
入排标准
- 年龄范围
- 14 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Fourteen - 18 years of age,
- •Scoliotic curve greater than 25 degrees, less than 45 degrees,
- •Stated willingness to do the yoga and yoga-like poses daily,
- •Written, signed consent by patient and parent/guardian
- •Pre-test Cobb films no less than 3 months old read by independent radiologists.
排除标准
- •Neurological, muscular or neuromuscular disease, (e.gs., cerebral palsy, myopathy, stroke),
- •Genetic abnormalities that affect limb growth, proportionality or metabolism, (e.gs., mucopolysaccharidoses, Marfan's syndrome, Refsums disease).
- •Pregnancy and other conditions prohibiting X-rays or minute(s)-long exertion (e.gs., congestive heart failure, great weakness, COPD).
- •Previous exposure to botulinum neurotoxin Type A. Sexually active female subjects must present a recent negative pregnancy test.
研究组 & 干预措施
Group I: Placebo isometric measure, no injection
Group I: no isometric yoga-like exercise, no injection given.
干预措施: Placebo (Behavioral)
Group II Isometric yoga-like exercise, placebo injection given
Group II isometric yoga-like exercise, injection of preservative-free normal saline.
干预措施: Isometric Yoga-like exercise (Behavioral)
Group III: True isometric exercise, botulinum injection
Group III: Isometric yoga-like exercise, botulinum injection given
干预措施: Botulinum toxin type A (Drug)
Group III: True isometric exercise, botulinum injection
Group III: Isometric yoga-like exercise, botulinum injection given
干预措施: Isometric Yoga-like exercise (Behavioral)
Crossover
After the three months, Arm I and Arm II patients will be given botulinum injections, and Group I will be given the proper yoga-like exercise. These two arms will constitute a further comparator with their own performances in the first 3 months of the study.
干预措施: Botulinum toxin type A (Drug)
Crossover
After the three months, Arm I and Arm II patients will be given botulinum injections, and Group I will be given the proper yoga-like exercise. These two arms will constitute a further comparator with their own performances in the first 3 months of the study.
干预措施: Isometric Yoga-like exercise (Behavioral)
结局指标
主要结局
Reduction in lumbar and thoracic scoliotic curve
时间窗: 3 months after crossover group injections
Measured by the Cobb angle in coronal X-rays
次要结局
未报告次要终点