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

Not Applicable

Completed

• Conditions: Spinal Cord Injury; Muscle Spasticity

• Registration Number: NCT00223873
• Lead Sponsor: US Department of Veterans Affairs

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2002-11
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-22
• Status Verified: 2006-05
• Study Completion: 2006-07
• Last Update Submitted: 2009-01-20
• Last Update Posted: 2009-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Miami Veterans Affairs Medical Center; 🇺🇸 Miami, Florida, United States