CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
DRX9000™device
Likely dose
DRX9000™ spinal decompression system — 6-week course of 20 outpatient treatment sessionsAI-extracted
Key inclusion· 4
  • ✓Age greater than 18 years
  • ✓Low back pain intensity greater than 4 on 0-10 numerical pain rating scale
  • ✓Completed necessary diagnostic and medical history evaluations to confirm diagnosis and eligibility
  • ✓Willing and able to complete 6-week 20-session outpatient DRX9000 treatment course and minimum 6-month follow-up
Key exclusion· 12
  • ✕Pregnancy
  • ✕Evidence of neurological motor deficits on clinical examination
  • ✕Evidence of spinal cord compression, metastatic cancer, tumor, hematoma, infection, or compression fracture
  • ✕Severe central stenosis with neurological deficits or nerve root entrapment

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00414596
NCT00414596Phase 2Completed
CompareCT.gov

Pilot Study to Evaluate The Effectiveness And Safety Of Axiom Worldwide Drx9000™ Spinal Decompression System For Treatment of Low Back Pain

NEMA Research, Inc.·interventional·Posted Dec 21, 2006·Updated Jun 6, 2016

In Brief

A Phase 2 clinical trial evaluating DRX9000™ for Low Back Pain. Completed, enrolled 20 participants across 3 sites.

Detailed Summary

This pilot study will evaluate the effectiveness and safety of the Axiom Worldwide DRX9000 for active treatment of chronic low back pain.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLow Back Pain
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 21, 2006
Enrollment StartDec 1, 2006
Primary CompletionApr 1, 2007
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 19.5 years ago

Interventions

DRX9000™device

Device is designed to apply spinal decompressive forces.