Post-reimbursement Study to Follow Spinal Neurostimulator Devices for Pain Therapy (French SCS Registry)

Chronic Pain Syndrome Clinical Trial

— SME  

Official title:

Post-reimbursement Study to Follow Spinal Neurostimulator Devices for Pain Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01778426
• Other study ID #: 1051
• Status: Completed
• Start date: January 2012
• Est. completion date: June 2016

Study information

• Verified date: May 2018
• Source: MedtronicNeuro
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Chronic Pain
• Chronic Pain Syndrome

Locations

Country	Name	City	State
France	Hôpital Foch - 40 rue Worth	Suresnes

Sponsors (2)

Lead Sponsor	Collaborator
MedtronicNeuro	Medtronic Bakken Research Center

Country where clinical trial is conducted

France, 

Outcome

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