The Use of Penile Vibratory Stimulation to Decrease Spasticity Following Spinal Cord Injury

Spinal Cord Injury Clinical Trial

Official title:

The Use of Penile Vibratory Stimulation to Decrease Spasticity Following Spinal Cord Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00223873
• Other study ID #: 7927-09
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: January 20, 2009
• Start date: November 2002
• Est. completion date: July 2006

Study information

• Verified date: May 2006
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Muscle Spasticity
• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Procedure:
• Penile Vibratory Stimulation

Locations

Country	Name	City	State
United States	Miami Veterans Affairs Medical Center	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (6)

Knutsson E, Lindblom U, Mårtensson 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. — View 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. — View 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. — View 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. — View Citation

Young RR, Delwaide PJ. Drug therapy: spasticity (first of two parts). N Engl J Med. 1981 Jan 1;304(1):28-33. — View Citation

Zierski J, Müller H, Dralle D, Wurdinger T. Implanted pump systems for treatment of spasticity. Acta Neurochir Suppl (Wien). 1988;43:94-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spasticity in the lower extremities will be scored per the
Primary	Ashworth scale at each weekly visit. Additionally,
Primary	subjects will record their daily spasm frequency on a 5
Primary	point scale in the form of a daily questionnaire. Intra
Primary	and inter-visit indicies of spas.
Secondary	Several questionnaires such as the CHART, SWLS, FIM, and IIEF are used to assess changes in quality of life and function.