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

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 Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Device: DRX9000

• Study Type: Observational
• Enrollment (Actual): 116

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Pain Management Clinic

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12-16 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Functional capacity, measured by activities of daily living	12-16 weeks
Proportion of patients using adjuvant analgesic medication	12-16 weeks

Collaborators and Investigators

• Sponsor: Integrity Life Sciences

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: March 22, 2016
• First Submitted That Met QC Criteria: April 5, 2016
• First Posted (Estimate): April 6, 2016

Study Record Updates

• Last Update Posted (Estimate): April 6, 2016
• Last Update Submitted That Met QC Criteria: April 5, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: Axiom-CA-L1N-8R1