Assessment of Activities of Daily Living in Adults With Chronic Low Back Pain Using a Nonoperative Treatment Modality

NCT ID: NCT02729181

Last Updated: 2016-04-06

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

Total Enrollment

116 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-02-28

Study Completion Date

2016-03-31

Brief Summary

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The investigators hypothesize that treatment with non-invasive spinal decompression reduces discogenic low back pain (LBP), decreases visual analog pain scale scores, increases activities of daily living and decreases medication use.

Detailed Description

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Conditions

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Low Back Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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DRX9000

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* at least 18 years of age;
* consented to the physician prescribed protocol;
* presented with discogenic low back pain defined as low back pain for minimum of 12 weeks;
* current CT scan

Exclusion Criteria

* metastatic cancer;
* previous spinal fusion or placement of stabilization hardware within 6 months;
* instrumentation or artificial discs;
* neurologic motor deficits, bladder, or sexual dysfunction;
* alcohol or drug abuse
* patient's with extremes of height (\< 147 cm or \> 203 cm) and body weight (\> 136 kg).
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Integrity Life Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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Axiom-CA-L1N-8R1

Identifier Type: -

Identifier Source: org_study_id

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