Pilot Study to Evaluate The Effectiveness And Safety Of Axiom Worldwide Drx9000™ Spinal Decompression System
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|ClinicalTrials.gov Identifier: NCT00414596|
Recruitment Status : Completed
First Posted : December 21, 2006
Results First Posted : June 6, 2016
Last Update Posted : June 6, 2016
|Condition or disease||Intervention/treatment||Phase|
|Low Back Pain||Device: DRX9000™||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study to Evaluate The Effectiveness And Safety Of Axiom Worldwide Drx9000™ Spinal Decompression System For Treatment of Low Back Pain|
|Study Start Date :||December 2006|
|Actual Primary Completion Date :||April 2007|
|Actual Study Completion Date :||April 2007|
Experimental: DRX Group
Patients using the device DRX9000™.
Device is designed to apply spinal decompressive forces.
- Post-treatment Numerical Pain Intensity Rating Scale (VRS), Which is a Scale From 0-10 (0=no Pain, 10= Worst Pain) [ Time Frame: Six weeks ]The numerical results of the post-treatment verbal numerical pain intensity rating scale (VRS) following completion of a standard six week series of 20 DRX9000 treatments.
- Recurrence for Significant (VRS Greater Than or Equal to 4) LBP Following Completion of 6 Weeks of DRX9000 Treatment. [ Time Frame: Six weeks ]The number of Subjects reporting VRS greater than or equal to 4 for LBP following completion of 6 weeks of DRX9000 treatment will be recorded.
- Change in Functional Capacity From Baseline to Six Weeks (The Revised Oswestry Pain Questionaire) [ Time Frame: Six weeks ]Subject functional capacity following 6 weeks of DRX9000 treatment will be measured as a numerical score by the Revised Oswestry Pain Questionaire (scale 0-50, 0=pain without effects). Functional capacity was assessed at Baseline, 3 Weeks and 6 Weeks.
- Patient's Satisfaction With Treatment Procedures Following 6 Weeks of DRX9000 Treatment. [ Time Frame: Six weeks ]Patient's satisfaction with treatment procedures following 6 weeks of DRX9000 treatment was measured on a scale from 0-10 (0= very unsatisfied, 10=very satisfied).
- Number of Adverse Events Following 6 Weeks of DRX9000 Treatment. [ Time Frame: Six weeks ]Total number of adverse events reported following 6 weeks of DRX9000 treatment.
- Number of Patients Who Withdraw From Study. [ Time Frame: 6 weeks ]Total number of patients who withdrew during the 6 weeks of treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00414596
|United States, California|
|Vibrance Medical Group|
|Beverly Hills, California, United States, 90212|
|United States, Florida|
|Naples Anesthesia and Pain Associates|
|Naples, Florida, United States, 34108|
|Active Health and Wellness Center|
|Tampa, Florida, United States, 33614|
|Principal Investigator:||John Leslie, MD||Mayo Clinic|
|Study Director:||Charlotte Richmond, PhD||NEMA Research, Inc.|
|Study Chair:||Joseph V Pergolizzi, MD||Naples Anesthesia and Pain Associates|