Back to resultsThe Use of Penile Vibratory Stimulation to Decrease Spasticity Following Spinal Cord Injury
Primary Purpose
Spinal Cord Injury, Muscle Spasticity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Penile Vibratory Stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injury focused on measuring Penile Vibratory Stimulation, Muscles Spasticity, Spasms, Ferti Care Vibrator, Antispasmotic treatment
Eligibility 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
Sites / Locations
- Miami Veterans Affairs Medical Center
Outcomes
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.
Full Information
NCT ID
NCT00223873
First Posted
September 13, 2005
Last Updated
January 20, 2009
Sponsor
US Department of Veterans Affairs
1. Study Identification
Unique Protocol Identification Number
NCT00223873
Brief Title
The Use of Penile Vibratory Stimulation to Decrease Spasticity Following Spinal Cord Injury
Official Title
The Use of Penile Vibratory Stimulation to Decrease Spasticity Following Spinal Cord Injury
Study Type
Interventional
2. Study Status
Record Verification Date
May 2006
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
US Department of Veterans Affairs
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury, Muscle Spasticity
Keywords
Penile Vibratory Stimulation, Muscles Spasticity, Spasms, Ferti Care Vibrator, Antispasmotic treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Penile Vibratory Stimulation
Primary Outcome Measure Information:
Title
Spasticity in the lower extremities will be scored per the
Title
Ashworth scale at each weekly visit. Additionally,
Title
subjects will record their daily spasm frequency on a 5
Title
point scale in the form of a daily questionnaire. Intra
Title
and inter-visit indicies of spas.
Secondary Outcome Measure Information:
Title
Several questionnaires such as the CHART, SWLS, FIM, and IIEF are used to assess changes in quality of life and function.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angelo E Gousse, MD
Organizational Affiliation
Miami VA Medical Center Urology Service
Official's Role
Principal Investigator
Facility Information:
Facility Name
Miami Veterans Affairs Medical Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
2369291
Citation
Maynard FM, Karunas RS, Waring WP 3rd. Epidemiology of spasticity following traumatic spinal cord injury. Arch Phys Med Rehabil. 1990 Jul;71(8):566-9.
Results Reference
background
PubMed Identifier
3213666
Citation
Zierski J, Muller H, Dralle D, Wurdinger T. Implanted pump systems for treatment of spasticity. Acta Neurochir Suppl (Wien). 1988;43:94-9. doi: 10.1007/978-3-7091-8978-8_21.
Results Reference
background
PubMed Identifier
6448959
Citation
Young RR, Delwaide PJ. Drug therapy: spasticity (first of two parts). N Engl J Med. 1981 Jan 1;304(1):28-33. doi: 10.1056/NEJM198101013040107. No abstract available.
Results Reference
background
PubMed Identifier
2657424
Citation
Penn RD, Savoy SM, Corcos D, Latash M, Gottlieb G, Parke B, Kroin JS. Intrathecal baclofen for severe spinal spasticity. N Engl J Med. 1989 Jun 8;320(23):1517-21. doi: 10.1056/NEJM198906083202303.
Results Reference
background
PubMed Identifier
4154365
Citation
Knutsson E, Lindblom U, Martensson A. Plasma and cerebrospinal fluid levels of baclofen (Lioresal) at optimal therapeutic responses in spastic paresis. J Neurol Sci. 1974 Nov;23(3):473-84. doi: 10.1016/0022-510x(74)90163-4. No abstract available.
Results Reference
background
PubMed Identifier
2487035
Citation
Ochs G, Struppler A, Meyerson BA, Linderoth B, Gybels J, Gardner BP, Teddy P, Jamous A, Weinmann P. Intrathecal baclofen for long-term treatment of spasticity: a multi-centre study. J Neurol Neurosurg Psychiatry. 1989 Aug;52(8):933-9. doi: 10.1136/jnnp.52.8.933.
Results Reference
background
Learn more about this trial
The Use of Penile Vibratory Stimulation to Decrease Spasticity Following Spinal Cord Injury
We'll reach out to this number within 24 hrs