Restoration of Disc Height Reduces Chronic Low Back Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Study Classification

OBSERVATIONAL

Brief Summary

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The investigators hypothesize that a 6-week treatment of non-invasive spinal decompression reduces discogenic low back pain (LBP), increases lumbar disk height, and that an increase in lumbar disc height is associated with decreased LBP.

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Detailed Description

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Conditions

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Chronic Low Back Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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DRX9000

Intervention Type DEVICE

DRX9000 - non-invasive spinal decompression. Treatments 28 min 5 x/wk x 2wks, 3x/wk x 2 wks, 2x/wk x 2 wks for a total of 20 treatments in a 6-week period

Interventions

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DRX9000

DRX9000 - non-invasive spinal decompression. Treatments 28 min 5 x/wk x 2wks, 3x/wk x 2 wks, 2x/wk x 2 wks for a total of 20 treatments in a 6-week period

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* at least 18 years of age;
* consented for the 6 weeks treatment protocol;
* presented with discogenic low back pain of at least 3 out of 10; AND
* current CT scan not older than 2 months.

Exclusion Criteria

* metastatic cancer;
* previous spinal fusion or placement of stabilization hardware;
* instrumentation or artificial discs;
* neurologic motor deficits, bladder, or sexual dysfunction;
* alcohol or drug abuse; OR
* litigation for a health-related claim (in process or pending for workers' compensation or personal injury).

Limitations of the spinal decompression system also led to the exclusion of patients with extremes of height (\< 147 cm or \> 203 cm) and body weight (\> 136 kg).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No