Chronic Pain Syndrome Clinical Trial
— SMEOfficial title:
Post-reimbursement Study to Follow Spinal Neurostimulator Devices for Pain Therapy
NCT number | NCT01778426 |
Other study ID # | 1051 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 2012 |
Est. completion date | June 2016 |
Verified date | May 2018 |
Source | MedtronicNeuro |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Completed |
Enrollment | 414 |
Est. completion date | June 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Foch - 40 rue Worth | Suresnes |
Lead Sponsor | Collaborator |
---|---|
MedtronicNeuro | Medtronic Bakken Research Center |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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). | 2 years | |
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). | 1 year and 2 years | |
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). | 1 year | |
Secondary | Concomitant Pain Relief Medication | Percentage of primo-implanted subjects taking pain relief medication at baseline, 1 and 2 years. | Baseline, 1 and 2 years | |
Secondary | Dose of Analgesics Level 3 (Morphinics) | Dose of analgesics level 3 (morphinics) summarized as equivalent morphine dose at baseline, 1 and 2 years. | Baseline, 1 and 2 years | |
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"). | 1 and 2 years | |
Secondary | Return to Work | Percentage of subjects being invalid at inclusion and active at 1 and 2 years. | 1 and 2 years |
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