NCT02729181

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2014

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

March 22, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 6, 2016

Completed
Last Updated

April 6, 2016

Status Verified

March 1, 2016

Enrollment Period

1.7 years

First QC Date

March 22, 2016

Last Update Submit

April 5, 2016

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Functional capacity, measured by activities of daily living

    12-16 weeks

  • Proportion of patients using adjuvant analgesic medication

    12-16 weeks

Interventions

DRX9000DEVICE

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pain Management Clinic

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2016

First Posted

April 6, 2016

Study Start

February 1, 2014

Primary Completion

November 1, 2015

Study Completion

March 1, 2016

Last Updated

April 6, 2016

Record last verified: 2016-03