Clinical trial NCT00223873: The Use of Penile Vibratory Stimulation to Decrease Spasticity Following Spinal Cord Injury
Official title: The Use of Penile Vibratory Stimulation to Decrease Spasticity Following Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Muscle Spasticity
Keywords: Penile Vibratory Stimulation
Muscles Spasticity
Spasms
Ferti Care Vibrator
Antispasmotic treatment
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2005-09-22
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

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 Criteria:

* 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

Primary outcomes:
measure: Spasticity in the lower extremities will be scored per the
measure: Ashworth scale at each weekly visit. Additionally,
measure: subjects will record their daily spasm frequency on a 5
measure: point scale in the form of a daily questionnaire. Intra
measure: and inter-visit indicies of spas.
Secondary outcomes:
measure: Several questionnaires such as the CHART, SWLS, FIM, and IIEF are used to assess changes in quality of life and function.
Other outcomes:
Locations:
city: Miami
country: United States
facility: Miami Veterans Affairs Medical Center
state: Florida
Study officials:
affiliation: Miami VA Medical Center Urology Service
name: Angelo E Gousse, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.