Efficacy of the Spinal Cord Stimulation System as Salvage Therapy
|Pain; Intractable Pain; Chronic Pain||Device: Precision for Spinal Cord Stimulation||Phase 4|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Efficacy of the Precision Spinal Cord Stimulation System as Salvage Therapy for Patients With Chronic Intractable Pain of the Trunk and or Limbs Who Have Failed Treatment With an Intraspinal Infusion Pump or Other Spinal Cord Stimulation Device|
- Reduction of pain during the trial period. [ Time Frame: Throughout Study ]
- Incidence of adverse events during the study period [ Time Frame: Throughout study ]
|Study Start Date:||August 2006|
|Study Completion Date:||April 2008|
|Primary Completion Date:||April 2008 (Final data collection date for primary outcome measure)|
Active Comparator: Precision for Spinal Cord Stimulation
Single arm Precision for Spinal Cord Stimulation
Device: Precision for Spinal Cord Stimulation
Precision System aids in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable back pain, and leg pain.
Other Name: PRECISION Spinal Cord Stimulator System (Precision System)
Chronic pain is managed by the sequential application of various strategies: medications, anesthetic injections, ablation, surgery, implantable intraspinal infusion pumps, and spinal cord stimulation. For a significant number of patients, however, these treatments are inadequate or cannot be tolerated. Those patients require another option for pain relief.
The therapy afforded by spinal cord stimulators is dependent on overlapping paresthesia with the painful areas. One of the leading reasons for explant of SCS systems (not including device failure or surgical complication) is the complaint of inadequate pain relief due to poor coverage of the painful area. Mounting evidence suggests that the clinical efficacy afforded by SCS varies with each manufacturer's technology. For instance, previously-implanted SCS patients report more complete coverage, better pain relief, and a more pleasant sensation associated with the paresthesia of the Precision system. The tight lead spacing and current fractionalization achievable with the Precision system may provide pain relief after failure with another SCS system.
This study will assess pain relief with the Precision system for patients with chronic, intractable pain who are refractory to treatment with other types of SCS systems and/or implantable intraspinal infusion pumps. Because Precision allows unique programming combinations not possible with other systems, it is expected that subjects will enjoy significant pain relief.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00387244
|Principal Investigator:||Eric Grigsby, MD||Spectrum Care|