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Completed

NCT Number: NCT01778426

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

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Key information

Conditions

Chronic Pain Syndrome

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Foch - 40 rue Worth

Suresnes, 92151, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Percentage of Subjects With at Least 50% Pain Relief in the Area of Predominant Pain at 2 Years

    Time frame: 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 outcomes

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

    Time frame: 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).

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

    Time frame: 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).

  3. Concomitant Pain Relief Medication

    Time frame: Baseline, 1 and 2 years

    Percentage of primo-implanted subjects taking pain relief medication at baseline, 1 and 2 years.

  4. Dose of Analgesics Level 3 (Morphinics)

    Time frame: Baseline, 1 and 2 years

    Dose of analgesics level 3 (morphinics) summarized as equivalent morphine dose at baseline, 1 and 2 years.

  5. Patient Satisfaction

    Time frame: 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").

  6. Return to Work

    Time frame: 1 and 2 years

    Percentage of subjects being invalid at inclusion and active at 1 and 2 years.

Sponsors and collaborators

Lead sponsor

MedtronicNeuro

Industry

Collaborators

  • Medtronic Cardiac Rhythm and Heart Failure

Registry information

Official study title

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

Acronym: SME

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jan 29, 2013
Registry last updated
Nov 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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