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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
Sponsor:
Information provided by:
Logan College of Chiropractic
ClinicalTrials.gov Identifier:
NCT00624988
First received: February 19, 2008
Last updated: October 16, 2008
Last verified: October 2008
History of Changes
  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 1
Phase 2

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:

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 June 13, 2013