The Use of Penile Vibratory Stimulation to Decrease Spasticity Following Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Spasticity in the lower extremities will be scored per the
研究概览
简要总结
The purpose of this study is to determine the effect of penile vibratory stimulation on the muscle spasticity of men with chronic spinal cord injury.
详细描述
Spinal cord injury can result in mild to severe muscle spasms that can both inhibit functional capability and increase the likelihood of injury due to fall. Anecdotal reports and a recent study suggest that triggering the ejaculatory reflex in men with vibratory stimulation can result in a significant decrease in spasm activity over a period of 2 to 42 hours. This study examines the effects of penile vibratory stimulation on spasticity when conducted daily in the home setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with a traumatic spinal cord injury
- •Level of injury is at T6 or below
- •Injured at least 6 months prior to study enrollment
- •Male, aged 18 to 70 years
- •Spasticity to a degree that either anti-spasticity medications have been or are being used or current spasticity is at 2 or greater on the Ashworth scale specifically for the quadriceps muscle group (knee flexion)
排除标准
- •Medical instability
- •Subjects may not use Cialis
- •Use of Viagra, Levitra, Caverject, or vacuum constriction devices is restricted to no less than 8 hours prior to daily vibratory therapy
- •Recent history of autonomic dysreflexia secondary to sexual stimulation
- •Presence of intrathecal Baclofen pumps
- •Inability or unwillingness to use the therapy daily
结局指标
主要结局
Spasticity in the lower extremities will be scored per the
Ashworth scale at each weekly visit. Additionally,
subjects will record their daily spasm frequency on a 5
point scale in the form of a daily questionnaire. Intra
and inter-visit indicies of spas.
次要结局
- Several questionnaires such as the CHART, SWLS, FIM, and IIEF are used to assess changes in quality of life and function.