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.
Investigators
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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