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Effectiveness of Mechanical Decompression for Low Back Pain Relief

NCT00704210 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2016-10-18

No results posted yet for this study

Summary

Objective To demonstrate the effectiveness of a conservative treatment approach for chronic low back pain that addresses the underlying problem of intervertebral disc lesions and degenerative disc disease, namely vertebral pressure on vital structures of the lumbar region.

Conditions

  • Low Back Pain

Interventions

DEVICE

SpineMed Table, Cert HealthSciences LLC

For Group A (the treated group) the following tension adjustments will be used: starting treatment tension will equal 1/4 body weight minus 10 lbs. Incremental increases of 4 lbs. per session will be implemented until optimum tensions are reached, which would be a maximum of ¼ body weight plus 25 lbs, unless distraction tensions cause discomfort, which would require a reduction of the tensions applied.

DEVICE

SpineMed Table, Cert HealthSciences LLC

Group B will receive sham decompression treatment (i.e. tension not exceeding 15 lbs) for 30 minutes and ice treatment for 15 minutes once a day during each treatment session. No incremental increases will be used for Group B.

Sponsors & Collaborators

  • State University of New York - Upstate Medical University

    lead OTHER

Principal Investigators

  • William D Grant, EdD · State University of New York - Upstate Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2008-12-31
Completion
2009-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00704210 on ClinicalTrials.gov