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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02729181
Enrollment
116
Registered
2016-04-06
Start date
2014-02-28
Completion date
2016-03-31
Last updated
2016-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

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.

Interventions

DEVICEDRX9000

Sponsors

Integrity Life Sciences
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
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 weeks0= no pain; 10=worst pain

Secondary

MeasureTime frame
Functional capacity, measured by activities of daily living12-16 weeks
Proportion of patients using adjuvant analgesic medication12-16 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026