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

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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified October 2008 by Logan College of Chiropractic. Recruitment status was Recruiting

First Received on February 19, 2008. Last Updated on October 16, 2008 History of Changes

Sponsor:	Logan College of Chiropractic
Information provided by:	Logan College of Chiropractic
ClinicalTrials.gov Identifier:	NCT00624988

Purpose

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

Condition	Intervention	Phase
Spinal Cord Injury	Procedure: Vibration Therapy	Phase I Phase II

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	The Effect of Vibration Therapy on the Bone Density of the Tiba in Patients With Spinal Cord Injury

Resource links provided by NLM:

MedlinePlus related topics: Bone Density Spinal Cord Injuries

U.S. FDA Resources

Further study details as provided by Logan College of Chiropractic:

Primary Outcome Measures:

Bone density scan [ Time Frame: within 7 days pre/post intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Single fiber EMG at neuromuscular junction [ Time Frame: 7 days pre/post intervention ] [ Designated as safety issue: No ]

Estimated Enrollment:	10
Study Start Date:	July 2008
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Vibration Therapy 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.	Procedure: Vibration Therapy 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00624988

Contacts

Contact: David V Lenihan, DC, PhD

(314) 614-5005

davidvlenihan@hotmail.com

Locations

United States, Missouri
Logan College of Chiropractic	Not yet recruiting
Chesterfield, Missouri, United States, 63006
Logan College of Chiropractic	Recruiting
Chesterfield, Missouri, United States, 63017
Contact: Dennis Enix, DC, MBA 636-230-1951 dennis.enix@logan.edu

Sponsors and Collaborators

Logan College of Chiropractic

Investigators

Principal Investigator:

David V Lenihan, DC, PhD

Logan College of Chiropractic

More Information

No publications provided

Responsible Party:	David Lenihan BA., D.C., Ph.D., M.C.C., CBiol MiBiol, FRSM, Logan University, College of Chiropractic
ClinicalTrials.gov Identifier:	NCT00624988 History of Changes
Other Study ID Numbers:	RD0723070100
Study First Received:	February 19, 2008
Last Updated:	October 16, 2008
Health Authority:	United States: Institutional Review Board

Keywords provided by Logan College of Chiropractic:

Spinal cord injury
vibration therapy
bone density

Additional relevant MeSH terms:

Spinal Cord Injuries
Raynaud Disease
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases

Trauma, Nervous System
Wounds and Injuries
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 09, 2012