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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date May 2018
Source MedtronicNeuro
Contact n/a
Is FDA regulated No
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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