NCT00223873

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2002

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

January 21, 2009

Status Verified

May 1, 2006

First QC Date

September 13, 2005

Last Update Submit

January 20, 2009

Conditions

Spinal Cord InjuryMuscle Spasticity

Keywords

Penile Vibratory StimulationMuscles SpasticitySpasmsFerti Care VibratorAntispasmotic treatment

Outcome Measures

Primary Outcomes (5)

  • 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 (1)

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

Interventions

Penile Vibratory StimulationPROCEDURE

Eligibility Criteria

Age18 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Miami Veterans Affairs Medical Center

Miami, Florida, 33125, United States

Location

Related Publications (6)

  • 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.

    PMID: 2369291BACKGROUND

  • 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.

    PMID: 3213666BACKGROUND

  • 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.

    PMID: 6448959BACKGROUND

  • 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.

    PMID: 2657424BACKGROUND

  • 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.

    PMID: 4154365BACKGROUND

  • 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.

    PMID: 2487035BACKGROUND

MeSH Terms

Conditions

Spinal Cord InjuriesMuscle SpasticitySpasm

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Angelo E Gousse, MD

    Miami VA Medical Center Urology Service

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Study Start

November 1, 2002

Study Completion

July 1, 2006

Last Updated

January 21, 2009

Record last verified: 2006-05

Locations

US(1)