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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Spinal Cord Injury; Muscle Spasticity	Procedure: Penile Vibratory Stimulation	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	30 participants
Allocation:	Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	The Use of Penile Vibratory Stimulation to Decrease Spasticity Following Spinal Cord Injury
Study Start Date :	November 2002
Actual Study Completion Date :	July 2006

Arms and Interventions

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Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Spasticity in the lower extremities will be scored per the
2. Ashworth scale at each weekly visit. Additionally,
3. subjects will record their daily spasm frequency on a 5
4. point scale in the form of a daily questionnaire. Intra
5. and inter-visit indicies of spas.

Secondary Outcome Measures :

1. Several questionnaires such as the CHART, SWLS, FIM, and IIEF are used to assess changes in quality of life and function.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Florida
Miami Veterans Affairs Medical Center
Miami, Florida, United States, 33125

Sponsors and Collaborators

VA Office of Research and Development

Investigators

Principal Investigator:	Angelo E Gousse, MD	Miami VA Medical Center Urology Service

More Information

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Publications:

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.

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

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

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.

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.

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.

ClinicalTrials.gov Identifier:	NCT00223873 History of Changes
Other Study ID Numbers:	7927-09
First Posted:	September 22, 2005
Last Update Posted:	January 21, 2009
Last Verified:	May 2006

Keywords provided by VA Office of Research and Development:

Penile Vibratory Stimulation; Muscles Spasticity; Spasms; Ferti Care Vibrator; Antispasmotic treatment

Additional relevant MeSH terms:

Muscle Spasticity; Wounds and Injuries; Spinal Cord Injuries; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System	Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms