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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Spinal Cord Injury, Muscle Spasticity

Intervention / Treatment
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* Procedure: Penile Vibratory Stimulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Penile Vibratory Stimulation|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Several questionnaires such as the CHART, SWLS, FIM, and IIEF are used to assess changes in quality of life and function. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Muscles Spasticity, Penile Vibratory Stimulation, Spasms, Ferti Care Vibrator, Antispasmotic treatment