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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02729181
Recruitment Status : Completed
First Posted : April 6, 2016
Last Update Posted : April 6, 2016
Information provided by (Responsible Party):
Integrity Life Sciences

Brief Summary:
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.

Condition or disease Intervention/treatment
Low Back Pain Device: DRX9000

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Study Type : Observational
Actual Enrollment : 116 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Assessment of Activities of Daily Living in Adults With Chronic Low Back Pain Using a Nonoperative Treatment Modality: A Retrospective Study
Study Start Date : February 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Primary Outcome Measures :
  1. Lower back pain measured on an 11-point numeric rating scale (VAS) with 0 reflecting no pain at all and 10 the worst imaginable pain. [ Time Frame: 12-16 weeks ]
    0= no pain; 10=worst pain

Secondary Outcome Measures :
  1. Functional capacity, measured by activities of daily living [ Time Frame: 12-16 weeks ]
  2. Proportion of patients using adjuvant analgesic medication [ Time Frame: 12-16 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pain Management Clinic

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).
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Responsible Party: Integrity Life Sciences Identifier: NCT02729181    
Other Study ID Numbers: Axiom-CA-L1N-8R1
First Posted: April 6, 2016    Key Record Dates
Last Update Posted: April 6, 2016
Last Verified: March 2016
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Neurologic Manifestations