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

NCT01778426 | Completed Results

• 1 other identifier: 1051
• Study Type: observational
• Target: 414
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain Syndrome

Keywords

Chronic neuropathic pain syndrome; Spinal Cord Stimulation; Painstim devices; Efficacy; Safety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Percentage of Subjects With at Least 50% Pain Relief in the Area of Non-predominant Pain

  1 year and 2 years

• Percentage of Subjects With at Least 50% Pain Relief in the Area of Predominant Pain at 1 Year

  1 year

• Concomitant Pain Relief Medication

  Baseline, 1 and 2 years

• Dose of Analgesics Level 3 (Morphinics)

  Baseline, 1 and 2 years

• Patient Satisfaction

  1 and 2 years

Study Arms (1)

Patients with Medtronic neurostimulator

Patients suffering from chronic neuropathic pain syndrome implanted (first implant or replacements) with a Medtronic neurostimulator.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients implanted (first implant or replacements) with a Medtronic neurostimulator in selected French sites .

You may qualify if:

• 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

You may not qualify if:

• Patient declined participation
• Patient is not available for follow up
• Stimulation of other body part than spinal

Sponsors & Collaborators

• MedtronicNeuro: lead
• Medtronic Cardiac Rhythm and Heart Failure: collaborator

Study Sites (1)

Hôpital Foch - 40 rue Worth

Suresnes, 92151, France

Location

Limitations and Caveats

The targeted pain area of the therapy was assumed to be the one with the predominant NPRS score at baseline. For the replacement group it was unknown if the therapy was active at the time of the device replacement (enrollment).

Results Point of Contact

• Title: Neuromodulation, Clinical Study Management
• Organization: Medtronic

medtronicneurotrials@medtronic.com

Study Officials

• Marie-Christine DJIAN, MD

  Hôpital Saint Anne, Paris

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2013
• First Posted: January 29, 2013
• Study Start: January 1, 2012
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: November 29, 2018
• Results First Posted: November 29, 2018

Record last verified: 2018-05

Locations

FR (1)