Chronic Pain
Conditions
Keywords
Chronic Low Back Pain, Dorsal Root Ganglion, Neurostimulator System, spinal cord stimulation
Brief summary
The purpose of this prospective post market observational pilot study is to evaluate the effect of DRG stimulation in the management of chronic discogenic pain in subjects who are refractory to other available treatments. Selected subjects will not be suitable candidates for lumbar spinal surgery and will meet the standard selection process for DRG stimulation as routinely utilised in the study centre. Results from this pilot study will inform current clinical practice and future comparative studies in this specific population.
Interventions
DEVICEDorsal root ganglion (DRG) stimulation
The role the DRG plays in the development and maintenance of chronic pain, we have developed a neurostimulator system for the management of chronic intractable pain by electrically stimulating the DRG
Sponsors
Abbott Medical Devices
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Subject of either gender between 18 and 65 years of age 2. Subject is able and willing to comply with the follow-up schedule and protocol 3. Subject is able to provide written informed consent 4. Chronic low back pain of at least 6 months 5. History consistent with discogenic low back pain (e.g. Pain produced on lumbar motion, significant functional limitation in sitting duration and tolerance) 6. Neurologic exam without marked motor deficit. 7. Definite/Highly Probable/Discogenic Pain as confirmed by provocative discography according to IASP/ISIS guidelines\* 8. Low Back Pain intensity should be 6 or higher measured on a NPRS at baseline 9. Meets all the inclusion criteria for the implantation of a neurostimulation system as typically utilised in the study centre 10. Subject has been screened by a multi-disciplinary panel including a psychologist and deemed suitable for implantation
Exclusion criteria
1. Female subject of childbearing potential is pregnant/nursing or plans to become pregnant during the course of the study 2. Escalating or changing pain condition within the past month as evidenced by investigator examination 3. BMI ≥35 4. Subject has had injection therapy or radiofrequency treatment for their low back pain within the past 3 months 5. Subject currently has an active implantable device including ICD, pacemaker, spinal cord stimulator or intrathecal drug pump 6. Subject is unable to operate the device 7. Severe disc degeneration at the affected level as evidenced by \>50% disc height loss on plain anteroposterior and lateral lumbar radiographs or CT/MRI. 8. Extruded or sequestered herniated nucleus pulposus at the affected level(s). 9. Previous lumbar back surgery (e.g. Laminectomy, discectomy or fusion) at the affected level(s) 10. Moderate to severe spinal stenosis due to osteophyte and/or ligamentous overgrowth as evidenced by MRI or CT in the previous 6 months 11. Moderate to severe endplate degenerative changes at the affected levels 12. Grade 1-2 spondylolisthesis 13. Previous Neurostimulation therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With 30% or Greater Reduction in Back Pain at 6 Months | 6 months | The number (percentage) of subjects who achieve a sustained and clinically meaningful reduction in the intensity of LBP of ≥30% or 2 points on a numerical pain rating scale (NPRS) in the implanted subjects at 6 month follow-up visit as compared to baseline. |
| Percentage of Subjects With 30% or Greater Reduction in Back Pain at 12 Months | 12 months | The number (percentage) of subjects who achieve a sustained and clinically meaningful reduction in the intensity of LBP of ≥30% or 2 points on a numerical pain rating scale (NPRS) in the implanted subjects at 12 month follow-up visit as compared to baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Improved Global Impression of Change at 6 Months | 6 Months | The subject was requested to rate their overall change in activity limitations, symptoms, emotions and overall quality of life related to his/her condition on a seven-point categorical scale (much worse, worse, somewhat worse, no change, slightly better, better and much better). Patients who reported to be much better or better are counted. |
| Percentage of Patients With Improved Global Impression of Change at 12 Months Using Trial System | 12 Months | The subject was requested to rate their overall change in activity limitations, symptoms, emotions and overall quality of life related to his/her condition on a seven-point categorical scale (much worse, worse, somewhat worse, no change, slightly better, better and much better). Patients who reported to be much better or better are counted. |
| Percentage of Subjects With 50% or Greater Reduction in Back Pain at 6 Months | 6 Months | Subjects experiencing 50% or more reduction in the intensity of the back pain. |
| Percentage of Subjects With 50% or Greater Reduction in Back Pain at 12 Months | 12 Months | Subjects experiencing 50% or more reduction in the intensity of the back pain. |
Countries
Netherlands
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Subjects Subjects with confirmed discogenic low back pain enrolled in the study | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | All Subjects |
|---|---|
| Age, Customized | 45 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 19 Participants |
| Region of Enrollment Netherlands | 20 participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 5 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Percentage of Subjects With 30% or Greater Reduction in Back Pain at 12 Months
The number (percentage) of subjects who achieve a sustained and clinically meaningful reduction in the intensity of LBP of ≥30% or 2 points on a numerical pain rating scale (NPRS) in the implanted subjects at 12 month follow-up visit as compared to baseline.
Time frame: 12 months
Population: 15 patients were implanted with the DRG Axium system, 14 patients have available data for pain relief at 12 months.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Subjects | Percentage of Subjects With 30% or Greater Reduction in Back Pain at 12 Months | 13 Participants |
Primary
Percentage of Subjects With 30% or Greater Reduction in Back Pain at 6 Months
The number (percentage) of subjects who achieve a sustained and clinically meaningful reduction in the intensity of LBP of ≥30% or 2 points on a numerical pain rating scale (NPRS) in the implanted subjects at 6 month follow-up visit as compared to baseline.
Time frame: 6 months
Population: 15 patients were implanted with the DRG Axium system.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Subjects | Percentage of Subjects With 30% or Greater Reduction in Back Pain at 6 Months | 11 Participants |
Secondary
Percentage of Patients With Improved Global Impression of Change at 12 Months Using Trial System
The subject was requested to rate their overall change in activity limitations, symptoms, emotions and overall quality of life related to his/her condition on a seven-point categorical scale (much worse, worse, somewhat worse, no change, slightly better, better and much better). Patients who reported to be much better or better are counted.
Time frame: 12 Months
Population: 14 patients had available data at 12 Months.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Subjects | Percentage of Patients With Improved Global Impression of Change at 12 Months Using Trial System | 11 Participants |
Secondary
Percentage of Patients With Improved Global Impression of Change at 6 Months
The subject was requested to rate their overall change in activity limitations, symptoms, emotions and overall quality of life related to his/her condition on a seven-point categorical scale (much worse, worse, somewhat worse, no change, slightly better, better and much better). Patients who reported to be much better or better are counted.
Time frame: 6 Months
Population: 15 patients had available data at 6 Months.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Subjects | Percentage of Patients With Improved Global Impression of Change at 6 Months | 10 Participants |
Secondary
Percentage of Subjects With 50% or Greater Reduction in Back Pain at 12 Months
Subjects experiencing 50% or more reduction in the intensity of the back pain.
Time frame: 12 Months
Population: 14 patients had available data at 12 Months.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Subjects | Percentage of Subjects With 50% or Greater Reduction in Back Pain at 12 Months | 11 Participants |
Secondary
Percentage of Subjects With 50% or Greater Reduction in Back Pain at 6 Months
Subjects experiencing 50% or more reduction in the intensity of the back pain.
Time frame: 6 Months
Population: 15 patients had available data at 6 Months.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Subjects | Percentage of Subjects With 50% or Greater Reduction in Back Pain at 6 Months | 11 Participants |