Muscle Spasticity, Spinal Cord Injury
Conditions
Keywords
Penile Vibratory Stimulation, Muscles Spasticity, Spasms, Ferti Care Vibrator, Antispasmotic treatment
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREPenile Vibratory Stimulation
Sponsors
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
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)
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Several questionnaires such as the CHART, SWLS, FIM, and IIEF are used to assess changes in quality of life and function. | — |
Countries
United States
Outcome results
None listed