Clinical trial NCT01629810: Use of Whole-Body Periodic Acceleration Therapy To Aches and Pains
Official title: An Unblinded Crossover Study of The Use of Whole-Body Periodic Acceleration Therapy To Treat Pain, Stiffness, Abnormal Gait and Balance
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Pain
Stiffness
Abnormal Gait
Balance
Keywords: 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
Lead sponsor: Center for Translational Medicine
Sponsor class: OTHER
First posted: 2012-06-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Self-report of pain
timeFrame: 2 weeks
Secondary outcomes:
measure: Quality of life
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Translational Medicine Group
state: Maryland
Study officials:
References:
citation: 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. doi: 10.1378/chest.128.4.2794.