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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00223873
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : January 21, 2009
Sponsor:
Information provided by:
VA Office of Research and Development

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.

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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

Resource links provided by the National Library of Medicine





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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00223873


Locations
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United States, Florida
Miami Veterans Affairs Medical Center
Miami, Florida, United States, 33125
Sponsors and Collaborators
US Department of Veterans Affairs
Investigators
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Principal Investigator: Angelo E Gousse, MD Miami VA Medical Center Urology Service
Publications:
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ClinicalTrials.gov Identifier: NCT00223873    
Other Study ID Numbers: 7927-09
First Posted: September 22, 2005    Key Record Dates
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:
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Muscle Spasticity
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations