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Sponsored by: |
Department of Veterans Affairs |
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Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00223873 |
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.
Condition | Intervention |
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Spinal Cord Injury Muscle Spasticity |
Procedure: Penile Vibratory Stimulation |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | The Use of Penile Vibratory Stimulation to Decrease Spasticity Following Spinal Cord Injury |
Estimated Enrollment: | 30 |
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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Diagnosed with a traumatic spinal cord injury
Exclusion Criteria:
United States, Florida | |
Miami Veterans Affairs Medical Center | |
Miami, Florida, United States, 33125 | |
Miami Veterans Affairs Medical Center | |
Miami, Florida, United States, 33125 |
Principal Investigator: | Angelo E Gousse, MD | Miami VA Medical Center Urology Service |
Study ID Numbers: | 7927-09 |
Study First Received: | September 13, 2005 |
Last Updated: | January 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00223873 |
Health Authority: | United States: Federal Government |
Penile Vibratory Stimulation Muscles Spasticity Spasms Ferti Care Vibrator Antispasmotic treatment |
Spasm Spinal Cord Diseases Wounds and Injuries Central Nervous System Diseases Disorders of Environmental Origin Trauma, Nervous System Spinal Cord Injuries |
Signs and Symptoms Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Muscle Hypertonia Neurologic Manifestations |
Neuromuscular Manifestations Nervous System Diseases |