Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Boston Scientific Corporation |
---|---|
Information provided by: | Boston Scientific Corporation |
ClinicalTrials.gov Identifier: | NCT00387244 |
The primary objective of this study is to evaluate the efficacy of spinal cord stimulation using the Precision implantable neurostimulation device for chronic and intractable pain of the trunk and or limbs in patients who have failed treatment with an intraspinal infusion pump or other SCS system.
Condition | Intervention | Phase |
---|---|---|
Pain; Intractable Pain; Chronic Pain |
Device: Precision |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Efficacy of the Precision Spinal Cord Stimulation (SCS) System as Salvage Therapy for Patients With Chronic and Intractable Pain of the Trunk and or Limbs Who Have Failed Previous Treatment With an Intraspinal Infusion Pump or Other SCS Device |
Enrollment: | 6 |
Study Start Date: | August 2006 |
Study Completion Date: | April 2008 |
Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Chronic pain is managed by the sequential application of various strategies: medications, anesthetic injections, neuroablation, 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Boston Scientific Corporation ( Lyn Pimentel, Clinical Project Manager ) |
Study ID Numbers: | SCS0506 |
Study First Received: | October 10, 2006 |
Last Updated: | October 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00387244 |
Health Authority: | United States: Institutional Review Board |
Pain; Back Pain; Neurostimulation |
Pain, Intractable Signs and Symptoms Neurologic Manifestations Pain Back Pain |
Nervous System Diseases |