Assessment of Activities of Daily Living in Adults With Chronic Low Back Pain Using a Nonoperative Treatment Modality
Completed
- Conditions
- Low Back Pain
- Registration Number
- NCT02729181
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 116
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).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. 12-16 weeks 0= no pain; 10=worst pain
- Secondary Outcome Measures
Name Time Method Functional capacity, measured by activities of daily living 12-16 weeks Proportion of patients using adjuvant analgesic medication 12-16 weeks