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Use of Whole-Body Periodic Acceleration Therapy To Aches and Pains (Exer-Rest)

This study is currently recruiting participants.
Verified June 2012 by Center for Translational Medicine
Sponsor:
Information provided by (Responsible Party):
Center for Translational Medicine
ClinicalTrials.gov Identifier:
NCT01629810
First received: June 26, 2012
Last updated: June 27, 2012
Last verified: June 2012
History of Changes
  Purpose

The purpose of this study is to test the effectiveness of whole body periodic acceleration for helping with symptoms of aches and pains suffered by many patients.


Condition Intervention Phase
Pain
Stiffness
Abnormal Gait
Balance
 Device: Whole body periodic acceleration (Exer-Rest)
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Unblinded Crossover Study of The Use of Whole-Body Periodic Acceleration Therapy To Treat Pain, Stiffness, Abnormal Gait and Balance

Further study details as provided by Center for Translational Medicine:

Primary Outcome Measures:
  • Self-report of pain [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Self-report of pain at start and completion of first course of treatment lasting for 2 weeks.


Secondary Outcome Measures:
  • Quality of life [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Self-report of change in quality following 2 weeks of treatment.


Estimated Enrollment: 30
Study Start Date: August 2011
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Whole body periodic acceleration (Exer-Rest)
    Lying on the vibrating bed for 45 minutes per session for 10 sessions over 2 weeks.
Detailed Description:

This is an unblinded cross-over study of whole-body periodic acceleration (WBPA) to ascertain if this treatment modality provides symptomatic relief of pain, stiffness, and abnormal gait and balance in a variety of conditions. The study will compare a specific mechanism of motion, whole-body periodic acceleration (WBPA), that has been shown to increase the release of beneficial mediators from the vascular endothelium into the circulation, to a control condition of slow passive motion that promotes relaxation but does not increase release of beneficial mediators into the circulation. The study tests the efficacy and safety of a commercially available device that consists of a motion platform, called Exer-Rest©, that is capable of producing both types of motion to be tested. In this investigation, 15 subjects will be randomly assigned to either procedure for 10 treatments for 2 weeks followed by a one-week "wash-out" period. Then the opposite treatment will be employed for two weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects qualifying for this study satisfy the following criteria:

  1. Over 18 years of age;
  2. Complain of either chronic pain, joint stiffness, and/or dysfunctions of gait and balance;
  3. Complaints have been annotated by a competent physician, and the subject has been evaluated for conditions that commonly contribute to the respective symptoms;
  4. Capable of completing the appropriate testing and baseline assessments, such as quantitative electroencephalography (qEEG) and questionnaires;
  5. Tolerate the motion and duration of treatment of the WBPA.
  6. Be available for regular visits to the research site for the duration of the study.

Exclusion Criteria:

WBPA is contraindicated for subjects who are pregnant or who suffer with unexplained leg pain, skin eruptions, or who have unstable spinal injuries or conditions. Subjects who cannot tolerate the motion and duration of treatment are also excluded.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01629810

Locations
United States, Maryland
Translational Medicine Group Recruiting
Bethesda, Maryland, United States, 20852
Contact: Karen P Walters, MSN     240-221-0000     kpw@tmgmd.com    
Principal Investigator: Stephen N Xenakis, M.D.            
Sponsors and Collaborators
Center for Translational Medicine
  More Information

Publications:

Responsible Party: Center for Translational Medicine
ClinicalTrials.gov Identifier: NCT01629810     History of Changes
Other Study ID Numbers: 20110957
Study First Received: June 26, 2012
Last Updated: June 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Center for Translational Medicine:
Motion platform at appropriate settings.
Relief of pain.
Improvement in quality of life, cognition, and mood.
 Effects of WBPA on cognition, mood, behavior, and functioning.
Dose response effect .
Gather data for long-term (2 year) study

ClinicalTrials.gov processed this record on May 21, 2013