Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single device arm | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dorsal root ganglion (DRG) stimulation | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rijnstate Ziekenhuis, Velp | Velp | Arnhem | 6883 AZ Velp | Netherlands |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | All Subjects | Subjects with confirmed discogenic low back pain enrolled in the study |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | Subjects with confirmed discogenic low back pain enrolled in the study |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | between 22 and 71 years of age |
| 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 | 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. | 15 patients were implanted with the DRG Axium system. | Posted | Count of Participants | Participants | 6 months |
|
|
device related AE's and SAE's were reported from Informed Consent signature until the last follow-up visit (12 Months)
Only device related AE's and SAE's were reported
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Subjects | Subjects with confirmed discogenic low back pain enrolled in the study |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increased Pain | General disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robyn Capobianco | Abbott | +1 512 286 4274 | robyn.capobianco@abbott.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 19, 2015 | Sep 4, 2024 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 6 Months |
| 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. | 12 Months |
| 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. | 6 Months |
| 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. | 12 Months |
| Mean |
| Full Range |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| 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. | 15 patients were implanted with the DRG Axium system, 14 patients have available data for pain relief at 12 months. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| 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. | 15 patients had available data at 6 Months. | Posted | Count of Participants | Participants | 6 Months |
|
|
|
| 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. | 14 patients had available data at 12 Months. | Posted | Count of Participants | Participants | 12 Months |
|
|
|
| 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. | 15 patients had available data at 6 Months. | Posted | Count of Participants | Participants | 6 Months |
|
|
|
| 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. | 14 patients had available data at 12 Months. | Posted | Count of Participants | Participants | 12 Months |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 5 |
| 20 |
| Pain at pocket | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
Not provided