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

US Department of Veterans Affairs30 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Spinal Cord Injury Muscle Spasticity

Interventions

Penile Vibratory StimulationPROCEDURE

Eligibility

Sex: MALEMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Miami Veterans Affairs Medical Center

Miami, Florida, United States

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.