NCT01629810

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_3 pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 28, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Last Updated

June 28, 2012

Status Verified

June 1, 2012

Enrollment Period

2 years

First QC Date

June 26, 2012

Last Update Submit

June 27, 2012

Conditions

PainStiffnessAbnormal GaitBalance

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

Outcome Measures

Primary Outcomes (1)

  • Self-report of pain

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

    2 weeks

Secondary Outcomes (1)

  • Quality of life

    2 weeks

Interventions

Whole body periodic acceleration (Exer-Rest)DEVICE

Lying on the vibrating bed for 45 minutes per session for 10 sessions over 2 weeks.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects qualifying for this study satisfy the following criteria:
  • Over 18 years of age;
  • Complain of either chronic pain, joint stiffness, and/or dysfunctions of gait and balance;
  • Complaints have been annotated by a competent physician, and the subject has been evaluated for conditions that commonly contribute to the respective symptoms;
  • Capable of completing the appropriate testing and baseline assessments, such as quantitative electroencephalography (qEEG) and questionnaires;
  • Tolerate the motion and duration of treatment of the WBPA.
  • Be available for regular visits to the research site for the duration of the study.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Translational Medicine Group

Bethesda, Maryland, 20852, United States

RECRUITING

Related 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. doi: 10.1378/chest.128.4.2794.

    PMID: 16236957BACKGROUND

MeSH Terms

Conditions

PainMobility LimitationBehavior

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 3
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2012

First Posted

June 28, 2012

Study Start

August 1, 2011

Primary Completion

August 1, 2013

Last Updated

June 28, 2012

Record last verified: 2012-06

Locations

US(1)