The Use of Penile Vibratory Stimulation to Decrease Spasticity Following Spinal Cord Injury - Full Text View

Sponsored by:	Department of Veterans Affairs
Information provided by:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00223873

Purpose

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	Intervention
Spinal Cord Injury Muscle Spasticity	Procedure: Penile Vibratory Stimulation

MedlinePlus related topics: Spinal Cord Injuries

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	The Use of Penile Vibratory Stimulation to Decrease Spasticity Following Spinal Cord Injury

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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

Estimated Enrollment:	30
Study Start Date:	November 2002
Study Completion Date:	July 2006

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

Ages Eligible for Study:	18 Years to 70 Years
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00223873

Locations

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

Sponsors and Collaborators

Department of Veterans Affairs

Investigators

Principal Investigator:

Angelo E Gousse, MD

Miami VA Medical Center Urology Service

More Information

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, Muller 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. 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.

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. 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.

Study ID Numbers:	7927-09
Study First Received:	September 13, 2005
Last Updated:	January 20, 2009
ClinicalTrials.gov Identifier:	NCT00223873
Health Authority:	United States: Federal Government

Keywords provided by Department of Veterans Affairs:

Penile Vibratory Stimulation
Muscles Spasticity
Spasms
Ferti Care Vibrator
Antispasmotic treatment

Study placed in the following topic categories:

Spasm
Spinal Cord Diseases
Wounds and Injuries
Central Nervous System Diseases
Disorders of Environmental Origin
Trauma, Nervous System
Spinal Cord Injuries

Signs and Symptoms
Muscle Spasticity
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neurologic Manifestations

Additional relevant MeSH terms:

Neuromuscular Manifestations
Nervous System Diseases

ClinicalTrials.gov processed this record on January 30, 2009