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

This study has been completed.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00223873
First received: September 13, 2005
Last updated: January 20, 2009
Last verified: May 2006
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Use of Penile Vibratory Stimulation to Decrease Spasticity Following Spinal Cord Injury

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Sponsors and Collaborators
Investigators
Principal Investigator: Angelo E Gousse, MD Miami VA Medical Center Urology Service
  More Information

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

Keywords provided by Department of Veterans Affairs:
Penile Vibratory Stimulation
Muscles Spasticity
Spasms
Ferti Care Vibrator
Antispasmotic treatment

Additional relevant MeSH terms:
Muscle Spasticity
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on September 22, 2014