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OpenTrials
Completed

NCT Number: NCT00200122

Restore Claims Characterization Study

The purpose of this study is to characterize the pain coverage capability of the RESTORE spinal cord stimulation (SCS) and assess health outcomes.

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Key information

Conditions

Chronic Refractory Pain Associated With Failed Back Surgery Syndrome, Epidural Fibrosis, Peripheral Causalgia, Complex Regional Pain Syndrome Autonomic Nervous System Diseases Complex Regional Pain Syndromes Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Contact Medtronic for Exact Location, Chicago, Illinois, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Has chronic refractory pain associated with one of the conditions currently approved for spinal cord stimulation as follows: Failed Back Syndrome, Degenerative Disk Disease (DDD), Herniated Disk pain refractory to conservative and surgical interventions, Peripheral Causalgia, Complex Regional Pain Syndrome (CRPS) or Reflex Sympathetic Dystrophy (RSD).
  • Primary pain in the lower half of the body.

Exclusion criteria

  • Requires, or will in the future, diathermy treatments.
  • Had implanted spinal cord stimulation system within the last six months.

Treatment and study plan

Spinal Cord Stimulation

Device

Primary outcomes

  1. The primary endpoint is to assesses the pain coverage capability of the RESTORE SCS system.

Secondary outcomes

  1. Secondary outcome measures include pain relief, quality of life, function, patient and physician acceptance.

Sponsors and collaborators

Lead sponsor

MedtronicNeuro

Industry

Registry information

Important dates

Study start
2005
Study completion
2007
First posted
Sep 20, 2005
Registry last updated
Jan 21, 2009

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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