Low Back Pain
Conditions
Brief summary
This pilot study will evaluate the effectiveness and safety of the Axiom Worldwide DRX9000 for active treatment of chronic low back pain.
Detailed description
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.
Interventions
DEVICEDRX9000™
Device is designed to apply spinal decompressive forces.
Sponsors
NEMA Research, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-treatment Numerical Pain Intensity Rating Scale (VRS), Which is a Scale From 0-10 (0=no Pain, 10= Worst Pain) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence for Significant (VRS Greater Than or Equal to 4) LBP Following Completion of 6 Weeks of DRX9000 Treatment. | 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) | 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. | 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. | Six weeks | Total number of adverse events reported following 6 weeks of DRX9000 treatment. |
| Number of Patients Who Withdraw From Study. | 6 weeks | Total number of patients who withdrew during the 6 weeks of treatment. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DRX Group Patients using the device DRX9000™. | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 2 |
Baseline characteristics
| Characteristic | DRX Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Age, Continuous | 46.6 years STANDARD_DEVIATION 15 |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 8 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
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.
Time frame: Six weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| DRX Group | 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 |
Comparison: Hypothesis: Patients with chronic low back pain who undergo spinal decompression with a standardized 6-week regimen consisting of 20 treatments with the spinal decompression system would experience \>50% reduction in their verbal score of pain intensity.~Power Analysis: Mean pain scores at time of enrollment were assumed to equal 6 with potential reduction in pain of 50%. To obtain 80% power at an alpha level of 0.05, sample size was estimated as 20 patients.p-value: 0.0001Mixed Models Analysis
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.
Time frame: Six weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| DRX Group | Change in Functional Capacity From Baseline to Six Weeks (The Revised Oswestry Pain Questionaire) | Baseline | 26 Change in units of scale |
| DRX Group | Change in Functional Capacity From Baseline to Six Weeks (The Revised Oswestry Pain Questionaire) | Week 3 | 14 Change in units of scale |
| DRX Group | Change in Functional Capacity From Baseline to Six Weeks (The Revised Oswestry Pain Questionaire) | Week 6 | 3 Change in units of scale |
Secondary
Number of Adverse Events Following 6 Weeks of DRX9000 Treatment.
Total number of adverse events reported following 6 weeks of DRX9000 treatment.
Time frame: Six weeks
Population: All subjects enrolled were included in the analysis. No adverse events related to study device were reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DRX Group | Number of Adverse Events Following 6 Weeks of DRX9000 Treatment. | 10 Number of Adverse Events |
Secondary
Number of Patients Who Withdraw From Study.
Total number of patients who withdrew during the 6 weeks of treatment.
Time frame: 6 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DRX Group | Number of Patients Who Withdraw From Study. | 2 participants |
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).
Time frame: Six weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| DRX Group | Patient's Satisfaction With Treatment Procedures Following 6 Weeks of DRX9000 Treatment. | 8.1 units on a scale |
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.
Time frame: Six weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DRX Group | Recurrence for Significant (VRS Greater Than or Equal to 4) LBP Following Completion of 6 Weeks of DRX9000 Treatment. | 1 participants |