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This pilot study will evaluate the effectiveness and safety of the Axiom Worldwide DRX9000 for active treatment of chronic low back pain.
Currently, there are no prospective safety and/or outcomes studies utilizing the DRX9000™ in the peer-reviewed medical literature. There are published trials utilizing similar machines which provided evidence in support of the FDA granted indications for use spinal decompression and of the DRX9000™. Axiom Worldwide has determined it will be of benefit to the continuing medical care of patients and a furthering of the scientific knowledge of the treatment of LBP to complete such a prospective evaluation using a standardized treatment protocol. This study will therefore attempt to establish and validate the safety and efficacy of this computerized spinal decompression system in the treatment of LBP and sciatica.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DRX Group | Experimental | Patients using the device DRX9000™. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DRX9000™ | Device | Device is designed to apply spinal decompressive forces. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-treatment Numerical Pain Intensity Rating Scale (VRS), Which is a Scale From 0-10 (0=no Pain, 10= Worst Pain) | 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. | Six weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence for Significant (VRS Greater Than or Equal to 4) LBP Following Completion of 6 Weeks of DRX9000 Treatment. | 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. | Six weeks |
| Change in Functional Capacity From Baseline to Six Weeks (The Revised Oswestry Pain Questionaire) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Leslie, MD | Mayo Clinic | Principal Investigator |
| Charlotte Richmond, PhD | NEMA Research, Inc. | Study Director |
| Joseph V Pergolizzi, MD | Naples Anesthesia and Pain Associates | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vibrance Medical Group | Beverly Hills | California | 90212 | United States | ||
| Naples Anesthesia and Pain Associates |
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| Label | URL |
|---|---|
| click here for more information about the DRX9000 | View source |
| Nema Research website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | DRX Group | Patients using the device DRX9000™. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | DRX Group | Patients using the device DRX9000™. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Post-treatment Numerical Pain Intensity Rating Scale (VRS), Which is a Scale From 0-10 (0=no Pain, 10= Worst Pain) | 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. | Posted | Median | Inter-Quartile Range | units on a scale | Six weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DRX Group | Patients using the device DRX9000™. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neck Pain | Musculoskeletal and connective tissue disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jospeph V Pergolizzi, MD | NEMA Research, Inc | 239-597-3564 | nemaresearch@aol.com |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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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. |
| Six weeks |
| Patient's Satisfaction With Treatment Procedures Following 6 Weeks of DRX9000 Treatment. | 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). | Six weeks |
| Number of Adverse Events Following 6 Weeks of DRX9000 Treatment. | Total number of adverse events reported following 6 weeks of DRX9000 treatment. | Six weeks |
| Number of Patients Who Withdraw From Study. | Total number of patients who withdrew during the 6 weeks of treatment. | 6 weeks |
| Naples |
| Florida |
| 34108 |
| United States |
| Active Health and Wellness Center | Tampa | Florida | 33614 | United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Recurrence for Significant (VRS Greater Than or Equal to 4) LBP Following Completion of 6 Weeks of DRX9000 Treatment. | 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. | Posted | Number | participants | Six weeks |
|
|
|
| Secondary | Change in Functional Capacity From Baseline to Six Weeks (The Revised Oswestry Pain Questionaire) | 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. | Posted | Median | Inter-Quartile Range | Change in units of scale | Six weeks |
|
|
|
| Secondary | Patient's Satisfaction With Treatment Procedures Following 6 Weeks of DRX9000 Treatment. | 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). | Posted | Mean | Inter-Quartile Range | units on a scale | Six weeks |
|
|
|
| Secondary | Number of Adverse Events Following 6 Weeks of DRX9000 Treatment. | Total number of adverse events reported following 6 weeks of DRX9000 treatment. | All subjects enrolled were included in the analysis. No adverse events related to study device were reported. | Posted | Number | Number of Adverse Events | Six weeks |
|
|
|
| Secondary | Number of Patients Who Withdraw From Study. | Total number of patients who withdrew during the 6 weeks of treatment. | Posted | Number | participants | 6 weeks |
|
|
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| 0 |
| 20 |
| 8 |
| 20 |
| Head Colds | General disorders |
|
| Sinus Headaches | General disorders |
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| Sinus Infection | Infections and infestations |
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| Shoulder Pain | Musculoskeletal and connective tissue disorders |
|
| Influenza | Infections and infestations |
|
| Vertigo | Ear and labyrinth disorders |
|
| Adrenal Insufficiency | Endocrine disorders |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Title |
|---|
| Measurements |
|---|
|