Chronic Pain Syndrome
Conditions
Keywords
Chronic neuropathic pain syndrome, Spinal Cord Stimulation, Painstim devices, Efficacy, Safety
Brief summary
Observational study to evaluate the long term efficacy of Spinal Cord Stimulation (SCS) over 2 years following SCS implant. This study is requested by French Health Authorities for reimbursement renewal, to maintain reimbursement for SCS in approved indication in France.
Interventions
None listed
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
MedtronicNeuro
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patient indicated for Spinal Cord Stimulation (pain therapy) * Patient implanted for less than 3 months or hospitalized for the implant of a Medtronic neurostimulator including: * primary implant with Spinal Cord Stimulation indication and positive test of stimulation or * device replacement of a Medtronic neurostimulator used for Pain Therapy * Evaluation of usual pain in the back, upper and lower limbs using a visual analogic scale must be available for the 3 days preceding implant. * Treatments must also be available * Patient read and signed the data release form
Exclusion criteria
* Patient declined participation * Patient is not available for follow up * Stimulation of other body part than spinal
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With at Least 50% Pain Relief in the Area of Predominant Pain at 2 Years | 2 years | Percentage of primo-implanted subjects who responded to the treatment, where response was defined as a pain relief of at least 50% in the area with predominant pain intensity from baseline to two years follow-up. Pain intensity was assessed using an 11-point (0-10) Numeric Pain Rating Scale (NPRS) ranging from 0 (no pain) to 10 (maximum pain possible). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With at Least 50% Pain Relief in the Area of Predominant Pain at 1 Year | 1 year | Percentage of primo-implanted subjects who responded to the treatment, where response was defined as a pain relief of at least 50% in the area with predominant pain intensity from baseline to one year follow-up. Pain intensity was assessed using an 11-point (0-10) Numeric Pain Rating Scale (NPRS) ranging from 0 (no pain) to 10 (maximum pain possible). |
| Concomitant Pain Relief Medication | Baseline, 1 and 2 years | Percentage of primo-implanted subjects taking pain relief medication at baseline, 1 and 2 years. |
| Percentage of Subjects With at Least 50% Pain Relief in the Area of Non-predominant Pain | 1 year and 2 years | Percentage of primo-implanted subjects who responded to the treatment, where response was defined as a pain relief of at least 50% in the area with non-predominant pain intensity at 1 and 2 years follow-up, compared to baseline. Pain intensity was assessed using an 11-point (0-10) Numeric Pain Rating Scale (NPRS) ranging from 0 (no pain) to 10 (maximum pain possible). |
| Patient Satisfaction | 1 and 2 years | Percentage of primo-implanted subjects satisfied with the treatment 1 and 2 years after implantation (defined as indicating pain relief improvement, daily life improvement, rather satisfied with the treatment, or would agree to the treatment again). |
| Return to Work | 1 and 2 years | Percentage of subjects being invalid at inclusion and active at 1 and 2 years. |
| Dose of Analgesics Level 3 (Morphinics) | Baseline, 1 and 2 years | Dose of analgesics level 3 (morphinics) summarized as equivalent morphine dose at baseline, 1 and 2 years. |
Countries
France
Participant flow
Recruitment details
The first subject enrolled in the study on January 13, 2012. The last subject was enrolled on December 19, 2013 and the last visit of the last subject was on January 11, 2016. A total of 414 patients were assessed for eligibility, across 28 sites in France, of which, 402 subjects were included in the final analysis.
Pre-assignment details
Not applicable; this study was non-randomized in which no treatment group was assigned.
Participants by arm
| Arm | Count |
|---|---|
| Primo-implant (PI) Subjects implanted for the first time (primary implant group) with Medtronic SCS devices, in order to assess the effectiveness of the treatment compared to pre-operative situation. | 264 |
| Replacement (RP) Subjects implanted with a new Medtronic SCS neurostimulator as a replacement of their Medtronic SCS devices (replacement group), in order to document the integrality of the practice and collect long-term data like complications and definitive explants. | 138 |
| Total | 402 |
Baseline characteristics
| Characteristic | Primo-implant (PI) | Replacement (RP) | Total |
|---|---|---|---|
| Age, Continuous | 49.6 years STANDARD_DEVIATION 9.6 | 56.5 years STANDARD_DEVIATION 11.4 | 52.0 years STANDARD_DEVIATION 10.8 |
| Sex: Female, Male Female | 117 Participants | 60 Participants | 177 Participants |
| Sex: Female, Male Male | 147 Participants | 78 Participants | 225 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 105 / 402 |
| serious Total, serious adverse events | 89 / 402 |
Outcome results
Primary
Percentage of Subjects With at Least 50% Pain Relief in the Area of Predominant Pain at 2 Years
Percentage of primo-implanted subjects who responded to the treatment, where response was defined as a pain relief of at least 50% in the area with predominant pain intensity from baseline to two years follow-up. Pain intensity was assessed using an 11-point (0-10) Numeric Pain Rating Scale (NPRS) ranging from 0 (no pain) to 10 (maximum pain possible).
Time frame: 2 years
Population: ITT - completer (n=198) consists of all primo-implant subjects with baseline and follow-up pain intensity data at 2 years completed. Among 198 subjects, 179 patients had a visit at one year completed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Primo-implant (PI) | Percentage of Subjects With at Least 50% Pain Relief in the Area of Predominant Pain at 2 Years | 59.1 Percentage of responders |
Secondary
Concomitant Pain Relief Medication
Percentage of primo-implanted subjects taking pain relief medication at baseline, 1 and 2 years.
Time frame: Baseline, 1 and 2 years
Population: ITT - completer (n=198) consists of all primo-implant subjects with baseline and follow-up pain intensity data at 2 years completed. Among 198 subjects, 179 patients had a visit at one year completed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primo-implant (PI) | Concomitant Pain Relief Medication | Analgesic, level 1 | 59.1 Percentage of subject taking drug |
| Primo-implant (PI) | Concomitant Pain Relief Medication | Analgesic, level 2 | 61.1 Percentage of subject taking drug |
| Primo-implant (PI) | Concomitant Pain Relief Medication | Analgesic, level 3 | 44.9 Percentage of subject taking drug |
| Primo-implant (PI) | Concomitant Pain Relief Medication | NSAID | 28.8 Percentage of subject taking drug |
| Primo-implant (PI) | Concomitant Pain Relief Medication | Antiepileptic | 69.7 Percentage of subject taking drug |
| Primo-implant (PI) | Concomitant Pain Relief Medication | Antidepressant | 54.0 Percentage of subject taking drug |
| Primo-implant - 1 Year | Concomitant Pain Relief Medication | Antidepressant | 33.7 Percentage of subject taking drug |
| Primo-implant - 1 Year | Concomitant Pain Relief Medication | Analgesic, level 1 | 43.3 Percentage of subject taking drug |
| Primo-implant - 1 Year | Concomitant Pain Relief Medication | NSAID | 9.0 Percentage of subject taking drug |
| Primo-implant - 1 Year | Concomitant Pain Relief Medication | Analgesic, level 3 | 19.7 Percentage of subject taking drug |
| Primo-implant - 1 Year | Concomitant Pain Relief Medication | Analgesic, level 2 | 35.4 Percentage of subject taking drug |
| Primo-implant - 1 Year | Concomitant Pain Relief Medication | Antiepileptic | 38.2 Percentage of subject taking drug |
| Primo-implant - 2 Years | Concomitant Pain Relief Medication | Analgesic, level 2 | 36.4 Percentage of subject taking drug |
| Primo-implant - 2 Years | Concomitant Pain Relief Medication | Analgesic, level 3 | 18.7 Percentage of subject taking drug |
| Primo-implant - 2 Years | Concomitant Pain Relief Medication | NSAID | 8.6 Percentage of subject taking drug |
| Primo-implant - 2 Years | Concomitant Pain Relief Medication | Antidepressant | 29.8 Percentage of subject taking drug |
| Primo-implant - 2 Years | Concomitant Pain Relief Medication | Analgesic, level 1 | 43.9 Percentage of subject taking drug |
| Primo-implant - 2 Years | Concomitant Pain Relief Medication | Antiepileptic | 30.3 Percentage of subject taking drug |
Secondary
Dose of Analgesics Level 3 (Morphinics)
Dose of analgesics level 3 (morphinics) summarized as equivalent morphine dose at baseline, 1 and 2 years.
Time frame: Baseline, 1 and 2 years
Population: ITT - completer (n=198) consists of all primo-implant subjects with baseline and follow-up pain intensity data at 2 years completed. Among 198 subjects, 179 patients had a visit at one year completed.~Here, patients taking analgesics level 3 medications were considered.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Primo-implant (PI) | Dose of Analgesics Level 3 (Morphinics) | 90.2 Daily equivalent morphine dose in mg | Standard Deviation 67.3 |
| Primo-implant - 1 Year | Dose of Analgesics Level 3 (Morphinics) | 102.6 Daily equivalent morphine dose in mg | Standard Deviation 95.8 |
| Primo-implant - 2 Years | Dose of Analgesics Level 3 (Morphinics) | 100.3 Daily equivalent morphine dose in mg | Standard Deviation 94.2 |
Secondary
Patient Satisfaction
Percentage of primo-implanted subjects satisfied with the treatment 1 and 2 years after implantation (defined as indicating pain relief improvement, daily life improvement, rather satisfied with the treatment, or would agree to the treatment again).
Time frame: 1 and 2 years
Population: ITT - completer (n=198) consists of all primo-implant subjects with baseline and follow-up pain intensity data at 2 years completed. Among 198 subjects, 179 patients had a visit at one year completed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primo-implant (PI) | Patient Satisfaction | Pain relief improvement | 89.9 Percentage of subjects satisfied |
| Primo-implant (PI) | Patient Satisfaction | daily life activity improvement | 82.0 Percentage of subjects satisfied |
| Primo-implant (PI) | Patient Satisfaction | treatment satisfaction | 89.9 Percentage of subjects satisfied |
| Primo-implant (PI) | Patient Satisfaction | agree to the treatment again | 92.1 Percentage of subjects satisfied |
| Primo-implant - 1 Year | Patient Satisfaction | agree to the treatment again | 92.9 Percentage of subjects satisfied |
| Primo-implant - 1 Year | Patient Satisfaction | Pain relief improvement | 89.3 Percentage of subjects satisfied |
| Primo-implant - 1 Year | Patient Satisfaction | treatment satisfaction | 91.4 Percentage of subjects satisfied |
| Primo-implant - 1 Year | Patient Satisfaction | daily life activity improvement | 81.8 Percentage of subjects satisfied |
Secondary
Percentage of Subjects With at Least 50% Pain Relief in the Area of Non-predominant Pain
Percentage of primo-implanted subjects who responded to the treatment, where response was defined as a pain relief of at least 50% in the area with non-predominant pain intensity at 1 and 2 years follow-up, compared to baseline. Pain intensity was assessed using an 11-point (0-10) Numeric Pain Rating Scale (NPRS) ranging from 0 (no pain) to 10 (maximum pain possible).
Time frame: 1 year and 2 years
Population: ITT - completer (n=198) consists of all primo-implant subjects with baseline and follow-up pain intensity data at 2 years completed. Among 198 subjects, 179 patients had a visit at one year completed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primo-implant (PI) | Percentage of Subjects With at Least 50% Pain Relief in the Area of Non-predominant Pain | 1 year | 46.9 Percentage of responders |
| Primo-implant (PI) | Percentage of Subjects With at Least 50% Pain Relief in the Area of Non-predominant Pain | 2 years | 46.5 Percentage of responders |
Secondary
Percentage of Subjects With at Least 50% Pain Relief in the Area of Predominant Pain at 1 Year
Percentage of primo-implanted subjects who responded to the treatment, where response was defined as a pain relief of at least 50% in the area with predominant pain intensity from baseline to one year follow-up. Pain intensity was assessed using an 11-point (0-10) Numeric Pain Rating Scale (NPRS) ranging from 0 (no pain) to 10 (maximum pain possible).
Time frame: 1 year
Population: ITT - completer (n=198) consists of all primo-implant subjects with baseline and follow-up pain intensity data at 2 years completed. Among 198 subjects, 179 patients had a visit at one year completed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Primo-implant (PI) | Percentage of Subjects With at Least 50% Pain Relief in the Area of Predominant Pain at 1 Year | 60.7 Percentage of responders |
Secondary
Return to Work
Percentage of subjects being invalid at inclusion and active at 1 and 2 years.
Time frame: 1 and 2 years
Population: ITT - completer (n=198) consists of all primo-implant subjects with baseline and follow-up pain intensity data at 2 years completed. Among 198 subjects, 179 patients had a visit at one year completed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Primo-implant (PI) | Return to Work | 8 Percentage of subjects |
| Primo-implant - 1 Year | Return to Work | 15 Percentage of subjects |