Chronic Refractory Pain Associated With Failed Back Surgery Syndrome, Epidural Fibrosis, Peripheral Causalgia, Complex Regional Pain Syndrome
Conditions
Brief summary
The purpose of this study is to characterize the pain coverage capability of the RESTORE spinal cord stimulation (SCS) and assess health outcomes.
Interventions
DEVICESpinal Cord Stimulation
Sponsors
MedtronicNeuro
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is to assesses the pain coverage capability of the RESTORE SCS system. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures include pain relief, quality of life, function, patient and physician acceptance. | — |
Countries
United States
Outcome results
None listed