The Use of Penile Vibratory Stimulation to Decrease Spasticity Following Spinal Cord Injury
NCT ID: NCT00223873
Last Updated: 2009-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2002-11-30
2006-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Penile Vibratory Stimulation
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
MALE
No
Sponsors
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US Department of Veterans Affairs
FED
Principal Investigators
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Angelo E Gousse, MD
Role: PRINCIPAL_INVESTIGATOR
Miami VA Medical Center Urology Service
Locations
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Miami Veterans Affairs Medical Center
Miami, Florida, United States
Countries
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References
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Zierski J, Muller H, Dralle D, Wurdinger T. Implanted pump systems for treatment of spasticity. Acta Neurochir Suppl (Wien). 1988;43:94-9. doi: 10.1007/978-3-7091-8978-8_21.
Maynard FM, Karunas RS, Waring WP 3rd. Epidemiology of spasticity following traumatic spinal cord injury. Arch Phys Med Rehabil. 1990 Jul;71(8):566-9.
Young RR, Delwaide PJ. Drug therapy: spasticity (first of two parts). N Engl J Med. 1981 Jan 1;304(1):28-33. doi: 10.1056/NEJM198101013040107. No abstract available.
Penn RD, Savoy SM, Corcos D, Latash M, Gottlieb G, Parke B, Kroin JS. Intrathecal baclofen for severe spinal spasticity. N Engl J Med. 1989 Jun 8;320(23):1517-21. doi: 10.1056/NEJM198906083202303.
Knutsson E, Lindblom U, Martensson A. Plasma and cerebrospinal fluid levels of baclofen (Lioresal) at optimal therapeutic responses in spastic paresis. J Neurol Sci. 1974 Nov;23(3):473-84. doi: 10.1016/0022-510x(74)90163-4. No abstract available.
Ochs G, Struppler A, Meyerson BA, Linderoth B, Gybels J, Gardner BP, Teddy P, Jamous A, Weinmann P. Intrathecal baclofen for long-term treatment of spasticity: a multi-centre study. J Neurol Neurosurg Psychiatry. 1989 Aug;52(8):933-9. doi: 10.1136/jnnp.52.8.933.
Other Identifiers
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7927-09
Identifier Type: -
Identifier Source: org_study_id
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