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Clinical Trials/NCT02729181
NCT02729181
Completed
Not Applicable

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

Integrity Life Sciences0 sites116 target enrollmentFebruary 2014
ConditionsLow Back Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Low Back Pain
Sponsor
Integrity Life Sciences
Enrollment
116
Primary Endpoint
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.
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2014
End Date
March 2016
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Integrity Life Sciences
Responsible Party
Sponsor

Eligibility Criteria

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).

Outcomes

Primary Outcomes

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 Outcomes

  • Functional capacity, measured by activities of daily living(12-16 weeks)
  • Proportion of patients using adjuvant analgesic medication(12-16 weeks)

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