An interventional study of SpineMed Table, Cert HealthSciences LLC and SpineMed Table, Cert HealthSciences LLC in Low Back Pain, sponsored by State University of New York - Upstate Medical University. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-10-18.
Sponsored by State University of New York - Upstate Medical University · Not applicable, Interventional, and Treatment
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.
Low back pain (LBP) is a common medical problem and a challenging condition to treat. This study will investigate the effectiveness of a conservative treatment approach for chronic LBP. To this point few treatment approaches specifically address the resolution of underlying pathologies leading to a high probability of recurrence of LBP. Further, current treatment options for lumbar disc pathology have been of limited demonstrated effectiveness. The purpose of this study is to determine whether a non-surgical therapeutic approach designed to effect intervertebral widening and allow for reduction of disc protrusion will reduce patients' pain and improve their activity levels.
The study will assess whether a computer-assisted traction treatment [decompression] protocol results in improvement in patient pain levels and daily activity levels. Further, to determine if such treatment results in intervertebral widening and reduction of any disc protrusions as demonstrated by direct imaging of the lumbar spine. A double-blind (treatment vs. sham treatment) design will be employed
Specific Aims To study the effectiveness of decompression therapy for LBP patients with lumbar disc herniation and degenerative disc problems.
To demonstrate that decompression therapy for LBP patients results in a demonstrated reduction in levels of reported pain.
To demonstrate that decompression therapy for LBP patients results in a demonstrated greater return to daily activities.
To demonstrate that decompression therapy for LBP patients results in increased intervertebral space and reduced disk protrusion (if present) as measured by MRI.
2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.
Browse Back Pain studies →State University of New York - Upstate Medical University is the lead sponsor of 154 studies on the registry; 17 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 4 (36%) have results posted.
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Exclusion Criteria:
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.
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
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.
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.
Pain will be measured using a 0-100 visual analog scale.
Time frame: 19 weeks
Functional activity will be measured using the Roland Morris activity scale
Time frame: 19 weeks
MRI outcome measures include thickness of disc (disc height, intervertebral space), extent of disc bulging, intervertebral alignment.
Time frame: 19 weeks
Physical and social activities and quality of life will be measured with the COOP
Time frame: 19 weeks
Functional health will be measured with the SF-36
Time frame: 19 weeks
Depression will be measured using the Geriatric Depression Scale (GDS)
Time frame: 19 weeks
Treatment satisfaction will be measured using a 5-point Likert scale.
Time frame: 19 weeks
Reduction in pain medication usage
Time frame: 19 weeks
This study is withdrawn, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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State University of New York - Upstate Medical University