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

Integrity Life Sciences116 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

116

Conditions

Low Back Pain

Interventions

DRX9000DEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

0= no pain; 10=worst pain

Time frame: 12-16 weeks

Secondary Outcomes

Functional capacity, measured by activities of daily living

Time frame: 12-16 weeks

Proportion of patients using adjuvant analgesic medication

Time frame: 12-16 weeks

Data from ClinicalTrials.gov

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