search
Back to results

The Effect of Vibration Therapy on the Bone Density of the Tiba in Patients With Spinal Cord Injury (SCI)

Primary Purpose

Spinal Cord Injury

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Vibration Therapy
Sponsored by
Logan College of Chiropractic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury focused on measuring Spinal cord injury, vibration therapy, bone density

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Over the age of 18 years
  • A spinal cord injury patient with injury above T12
  • Injury below T4 to avoid respiratory complication.
  • An ASIA classification of A or B

Exclusion Criteria:

  • Non complicating organic factors such as heart disease, high blood pressure, stroke
  • Exercise where electrical therapy is used while the trial is being conducted
  • A bone density measure 3 times below normal mineralization levels as measured on the first bone density scan prior to entry in to the study
  • Surgical implants below the level of T12
  • Local infection, acute inflammation, injury, tumors or other malignancy, recent wounds, diabetes
  • Any unstable joints of the lower extremity, recent hip and knee joints or fitted hip or knee pins, bolts and/or plates
  • Acute thrombosis
  • Severe migraine, epilepsy
  • Serious cardiovascular disease, wearing a pacemaker
  • Any Spinal manipulation within one year of the study
  • Any implanted device or prosthesis or intrauterine IUD type of device pregnancy

Sites / Locations

  • Logan College of Chiropractic
  • Logan College of ChiropracticRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vibration Therapy

Arm Description

Treatment will consist of 10 sessions of 60 seconds each with one minute intervals in between at 50 Hz frequency three times per week for three months.

Outcomes

Primary Outcome Measures

Bone density scan

Secondary Outcome Measures

Single fiber EMG at neuromuscular junction

Full Information

First Posted
February 19, 2008
Last Updated
October 16, 2008
Sponsor
Logan College of Chiropractic
search

1. Study Identification

Unique Protocol Identification Number
NCT00624988
Brief Title
The Effect of Vibration Therapy on the Bone Density of the Tiba in Patients With Spinal Cord Injury
Acronym
SCI
Official Title
The Effect of Vibration Therapy on the Bone Density of the Tiba in Patients With Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Unknown status
Study Start Date
July 2008 (undefined)
Primary Completion Date
February 2009 (Anticipated)
Study Completion Date
February 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Logan College of Chiropractic

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this investigation is to determine the effect of lower limb vibration therapy on bone density in the tibia in patients with spinal cord injury. The second purpose is to assess the neuromuscular junction variability at the motor units of the tibialis anterior muscle after a sequence of lower limb vibration therapy

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
Spinal cord injury, vibration therapy, bone density

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vibration Therapy
Arm Type
Experimental
Arm Description
Treatment will consist of 10 sessions of 60 seconds each with one minute intervals in between at 50 Hz frequency three times per week for three months.
Intervention Type
Procedure
Intervention Name(s)
Vibration Therapy
Intervention Description
Treatment will consist of 10 sessions of 60 seconds each with one minute intervals in between at 50 Hz frequency three times per week for three months.
Primary Outcome Measure Information:
Title
Bone density scan
Time Frame
within 7 days pre/post intervention
Secondary Outcome Measure Information:
Title
Single fiber EMG at neuromuscular junction
Time Frame
7 days pre/post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Over the age of 18 years A spinal cord injury patient with injury above T12 Injury below T4 to avoid respiratory complication. An ASIA classification of A or B Exclusion Criteria: Non complicating organic factors such as heart disease, high blood pressure, stroke Exercise where electrical therapy is used while the trial is being conducted A bone density measure 3 times below normal mineralization levels as measured on the first bone density scan prior to entry in to the study Surgical implants below the level of T12 Local infection, acute inflammation, injury, tumors or other malignancy, recent wounds, diabetes Any unstable joints of the lower extremity, recent hip and knee joints or fitted hip or knee pins, bolts and/or plates Acute thrombosis Severe migraine, epilepsy Serious cardiovascular disease, wearing a pacemaker Any Spinal manipulation within one year of the study Any implanted device or prosthesis or intrauterine IUD type of device pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David V Lenihan, DC, PhD
Phone
(314) 614-5005
Email
davidvlenihan@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David V Lenihan, DC, PhD
Organizational Affiliation
Logan College of Chiropractic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Logan College of Chiropractic
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63006
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Logan College of Chiropractic
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dennis Enix, DC, MBA
Phone
636-230-1951
Email
dennis.enix@logan.edu

12. IPD Sharing Statement

Learn more about this trial

The Effect of Vibration Therapy on the Bone Density of the Tiba in Patients With Spinal Cord Injury

We'll reach out to this number within 24 hrs