Phase 2
Completed N=20
Pilot Study to Evaluate The Effectiveness And Safety Of Axiom Worldwide Drx9000™ Spinal Decompression System
Source: ClinicalTrials.gov NCT00414596 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jun 2016
Primary outcomePrimary: Post-treatment Numerical Pain Intensity Rating Scale (VRS), Which is a Scale From 0-10 (0=no Pain, 10= Worst Pain) — 0 units on a scale — p=.0001
Summary
This pilot study will evaluate the effectiveness and safety of the Axiom Worldwide DRX9000 for active treatment of chronic low back pain.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post-treatment Numerical Pain Intensity Rating Scale (VRS), Which is a Scale From 0-10 (0=no Pain, 10= Worst Pain) |
— | .0001 sig |
| SECONDARY Recurrence for Significant (VRS Greater Than or Equal to 4) LBP Following Completion of 6 Weeks of DRX9000 Treatment. |
1 | — |
| SECONDARY Change in Functional Capacity From Baseline to Six Weeks (The Revised Oswestry Pain Questionaire) |
26; 14; 3 | — |
| SECONDARY Patient's Satisfaction With Treatment Procedures Following 6 Weeks of DRX9000 Treatment. |
8.1 | — |
| SECONDARY Number of Adverse Events Following 6 Weeks of DRX9000 Treatment. |
10 | — |
| SECONDARY Number of Patients Who Withdraw From Study. |
2 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female, greater than 18 years of age
- Able to understand possible risks and benefits and provide written informed consent (ICF) to the IRB approved clinical multimodal protocol
- LBP with an intensity level of greater than 4 on an eleven point numerical pain rating scale (VRS) of 0-10 (with 0 - no pain and 10 - worst possible pain)
- Completed the necessary diagnostic and medical history evaluations as described in the protocol to confirm the patient's diagnosis and eligibility for the study and DRX9000 treatment protocol.
- Willing and able to complete a six week 20 session of DRX9000 outpatient treatments and a minimum of 6 months follow-up
Exclusion Criteria
- Pregnancy
- Evidence of neurological motor deficits on clinical examination
- Evidence of spinal cord compression, metastatic cancer, tumor, hematoma, infection or compression fracture
- Evidence of severe central stenosis with neurological deficits or nerve root entrapment
- Litigation for health-related claim (in process or pending), Worker's Compensation, or Personal Injury
- Previous spine fusion surgery, insertion of hardware or artificial disc
- Hemiplegia or paraplegia
- History of severe cardiovascular or metabolic disease, or abdominal aortic aneurysm
- Unwillingness to postpone other types of therapy for LBP during the 6 week treatment sessions
- Known alcohol abuse or drug abuse
- Height less than 4 feet 10 inches (147 cm) or greater than 6 feet 8 inches (203 cm)
- Body weight greater than 300 pounds (136 kg)
Data sourced from ClinicalTrials.gov (NCT00414596). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.