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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01629810
Recruitment Status : Unknown
Verified June 2012 by Center for Translational Medicine.
Recruitment status was:  Recruiting
First Posted : June 28, 2012
Last Update Posted : June 28, 2012
Information provided by (Responsible Party):
Center for Translational Medicine

Brief Summary:
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 or disease Intervention/treatment Phase
Pain Stiffness Abnormal Gait Balance Device: Whole body periodic acceleration (Exer-Rest) Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : August 2011
Estimated Primary Completion Date : August 2013

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.

Primary Outcome Measures :
  1. Self-report of pain [ Time Frame: 2 weeks ]
    Self-report of pain at start and completion of first course of treatment lasting for 2 weeks.

Secondary Outcome Measures :
  1. Quality of life [ Time Frame: 2 weeks ]
    Self-report of change in quality following 2 weeks of treatment.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01629810

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

Responsible Party: Center for Translational Medicine Identifier: NCT01629810     History of Changes
Other Study ID Numbers: 20110957
First Posted: June 28, 2012    Key Record Dates
Last Update Posted: June 28, 2012
Last Verified: June 2012

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