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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Penile Vibratory Stimulation | Procedure |
| Measure | Description | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Several questionnaires such as the CHART, SWLS, FIM, and IIEF are used to assess changes in quality of life and function. |
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Inclusion Criteria:
Diagnosed with a traumatic spinal cord injury
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Angelo E Gousse, MD | Miami VA Medical Center Urology Service | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami Veterans Affairs Medical Center | Miami | Florida | 33125 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 2369291 | Background | 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. | |
| 3213666 | Background | 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. |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D009128 | Muscle Spasticity |
| D013035 | Spasm |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| 6448959 | Background | 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. |
| 2657424 | Background | 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. |
| 4154365 | Background | 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. |
| 2487035 | Background | 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. |
| D014947 | Wounds and Injuries |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |