Use of Whole-Body Periodic Acceleration Therapy To Aches and Pains

Phase 3

• Conditions: Pain; Balance; Stiffness; Abnormal Gait

• Registration Number: NCT01629810
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2011-08
• Status Verified: 2012-06
• Study First Submitted: 2012-06-26
• Study First Submitted QC: 2012-06-27
• Last Update Submitted: 2012-06-27
• Study First Posted: 2012-06-28
• Last Update Posted: 2012-06-28
• Primary Completion: 2013-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Self-report of pain	2 weeks	Self-report of pain at start and completion of first course of treatment lasting for 2 weeks.

Secondary Outcome Measures

Name	Time	Method
Quality of life	2 weeks	Self-report of change in quality following 2 weeks of treatment.

Trial Locations

Locations (1)

Translational Medicine Group; 🇺🇸 Bethesda, Maryland, United States