CompletedPhase 4

Restore Claims Characterization Study

United States100 participantsStarted 2005-01

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

Trial details

NCT IDNCT00200122

SponsorMedtronicNeuro

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

View on ClinicalTrials.gov More Chronic Refractory Pain Associated With Failed Back Surgery Syndrome, Epidural Fibrosis, Peripheral Causalgia, Complex Regional Pain Syndrome trials