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

Spinal Cord Injury Clinical Trial

— SCI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00624988
• Other study ID #: RD0723070100
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: February 19, 2008
• Last updated: October 16, 2008
• Start date: July 2008
• Est. completion date: February 2009

Study information

• Verified date: October 2008
• Source: Logan College of Chiropractic
• Contact: David V Lenihan, DC, PhD
• Phone: (314) 614-5005
• Email: davidvlenihan[@]hotmail.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

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.

Locations

Country	Name	City	State
United States	Logan College of Chiropractic	Chesterfield	Missouri
United States	Logan College of Chiropractic	Chesterfield	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Logan College of Chiropractic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone density scan		within 7 days pre/post intervention	No
Secondary	Single fiber EMG at neuromuscular junction		7 days pre/post intervention	No