Use of Whole-Body Periodic Acceleration Therapy To Aches and Pains (Exer-Rest)
Tracking Information | |
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First Received Date ICMJE | June 26, 2012 |
Last Updated Date | June 27, 2012 |
Start Date ICMJE | August 2011 |
Estimated Primary Completion Date | August 2013 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE |
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. |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT01629810 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE |
Quality of life [ Time Frame: 2 weeks ] [ Designated as safety issue: No ] Self-report of change in quality following 2 weeks of treatment. |
Original Secondary Outcome Measures ICMJE | Same as current |
Current Other Outcome Measures ICMJE | |
Original Other Outcome Measures ICMJE | |
Descriptive Information | |
Brief Title ICMJE | Use of Whole-Body Periodic Acceleration Therapy To Aches and Pains |
Official Title ICMJE | An Unblinded Crossover Study of The Use of Whole-Body Periodic Acceleration Therapy To Treat Pain, Stiffness, Abnormal Gait and Balance |
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. |
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 ICMJE | Interventional |
Study Phase | Phase 3 |
Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
Condition ICMJE |
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Intervention ICMJE | Device: Whole body periodic acceleration (Exer-Rest)
Lying on the vibrating bed for 45 minutes per session for 10 sessions over 2 weeks. |
Study Arm (s) | |
Publications * | 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. |
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Recruitment Information | |
Recruitment Status ICMJE | Recruiting |
Estimated Enrollment ICMJE | 30 |
Completion Date | |
Estimated Primary Completion Date | August 2013 (final data collection date for primary outcome measure) |
Eligibility Criteria ICMJE | Inclusion Criteria: Subjects qualifying for this study satisfy the following criteria:
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. |
Gender | Both |
Ages | 18 Years to 65 Years |
Accepts Healthy Volunteers | No |
Contacts ICMJE | |
Location Countries ICMJE | United States |
Administrative Information | |
NCT Number ICMJE | NCT01629810 |
Other Study ID Numbers ICMJE | 20110957 |
Has Data Monitoring Committee | No |
Responsible Party | Center for Translational Medicine |
Study Sponsor ICMJE | Center for Translational Medicine |
Collaborators ICMJE | |
Investigators ICMJE | |
Information Provided By | Center for Translational Medicine |
Verification Date | June 2012 |
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |