The Use of Penile Vibratory Stimulation to Decrease Spasticity Following Spinal Cord Injury
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Use of Penile Vibratory Stimulation to Decrease Spasticity Following Spinal Cord Injury|
- 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.
- Several questionnaires such as the CHART, SWLS, FIM, and IIEF are used to assess changes in quality of life and function.
|Study Start Date:||November 2002|
|Study Completion Date:||July 2006|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00223873
|United States, Florida|
|Miami Veterans Affairs Medical Center|
|Miami, Florida, United States, 33125|
|Principal Investigator:||Angelo E Gousse, MD||Miami VA Medical Center Urology Service|