Status:
COMPLETED
The Use of Penile Vibratory Stimulation to Decrease Spasticity Following Spinal Cord Injury
Lead Sponsor:
US Department of Veterans Affairs
Conditions:
Spinal Cord Injury
Muscle Spasticity
Eligibility:
MALE
18-70 years
Phase:
NA
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 sugges...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
End Date :
July 1 2006
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00223873
Start Date
November 1 2002
End Date
July 1 2006
Last Update
January 21 2009
Active Locations (1)
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1
Miami Veterans Affairs Medical Center
Miami, Florida, United States, 33125