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

June 26, 2012
June 27, 2012
August 2011
August 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01629810 on ClinicalTrials.gov Archive Site
Quality of life [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Self-report of change in quality following 2 weeks of treatment.
Same as current
 
 
 
Use of Whole-Body Periodic Acceleration Therapy To Aches and Pains
An Unblinded Crossover Study of The Use of Whole-Body Periodic Acceleration Therapy To Treat Pain, Stiffness, Abnormal Gait and Balance

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.

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.

Interventional
Phase 3
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Pain
  • Stiffness
  • Abnormal Gait
  • Balance
Device: Whole body periodic acceleration (Exer-Rest)
Lying on the vibrating bed for 45 minutes per session for 10 sessions over 2 weeks.
 
Sackner MA, Gummels E, Adams JA. Effect of moderate-intensity exercise, whole-body periodic acceleration, and passive cycling on nitric oxide release into circulation. Chest. 2005 Oct;128(4):2794-803.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
 
August 2013   (final data collection date for primary outcome measure)

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.

Both
18 Years to 65 Years
No
 
United States
 
NCT01629810
20110957
No
Center for Translational Medicine
Center for Translational Medicine
 
 
Center for Translational Medicine
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP