Skip to main content
OpenTrials
Completed

NCT Number: NCT00223873

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Spinal Cord Injury Central Nervous System Diseases Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Spasm Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Miami Veterans Affairs Medical Center

Miami, Florida, 33125, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Penile Vibratory Stimulation

Procedure

Primary outcomes

  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 outcomes

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

Sponsors and collaborators

Lead sponsor

US Department of Veterans Affairs

Fed

Registry information

Important dates

Study start
2002
Study completion
2006
First posted
Sep 22, 2005
Registry last updated
Jan 21, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.