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

Pain Clinical Trial

— Exer-Rest  

Official title:

An Unblinded Crossover Study of The Use of Whole-Body Periodic Acceleration Therapy To Treat Pain, Stiffness, Abnormal Gait and Balance

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01629810
• Other study ID #: 20110957
• Status: Recruiting
• Phase: Phase 3
• First received: June 26, 2012
• Last updated: June 27, 2012
• Start date: August 2011

Study information

• Verified date: June 2012
• Source: Center for Translational Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abnormal Gait
• Balance
• Pain
• Stiffness

Intervention

Device:
• Whole body periodic acceleration (Exer-Rest)
Lying on the vibrating bed for 45 minutes per session for 10 sessions over 2 weeks.

Locations

Country	Name	City	State
United States	Translational Medicine Group	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Center for Translational Medicine

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-report of pain	Self-report of pain at start and completion of first course of treatment lasting for 2 weeks.	2 weeks	No
Secondary	Quality of life	Self-report of change in quality following 2 weeks of treatment.	2 weeks	No