Efficacy of the Spinal Cord Stimulation System as Salvage Therapy

Launched by BOSTON SCIENTIFIC CORPORATION · Oct 10, 2006

Keywords

ClinConnect Summary

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 complain...

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Eligibility criteria

• Inclusion Criteria:
• • Have chronic and intractable neuropathic pain of the trunk and/or limbs of moderate to severe intensity and have failed treatment with an intraspinal infusion pump or other SCS device. Determination of failure of treatment will be based on subject feedback. Subjects with an active intraspinal infusion pump but with inadequate pain control will be allowed to participate;
• • Be 18 years of age or older;
• • Be an appropriate candidate for the surgical procedures required for this study;
• • Be willing and able to comply with all study related procedures and visits;
• • Be capable of reading and understanding patient information materials and giving written informed consent.
• Exclusion Criteria:
• • Have failed immediate past treatment with an intraspinal infusion pump or other SCS device because of technical reasons associated with the device such as unresolved lead migration, battery depletion, etc.;
• • Have any evidence of neurologic instability requiring surgery;
• • Have any significant medical condition that in the opinion of the investigator may interfere with the conduct of the study or may adversely affect the subject's safety during the study;
• • Have any other active implantable device with the exception of a intraspinal infusion pump for pain medications;
• • Are pregnant or lactating or planning to become pregnant in the next year;
• • Have participated in any investigational drug or device trial in the last 4 weeks or plan to participate in any other investigational drug or device trial while on this study.