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Efficacy of the Spinal Cord Stimulation System as Salvage Therapy

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ClinicalTrials.gov Identifier: NCT00387244
Recruitment Status : Terminated (Insufficient Data Collected)
First Posted : October 12, 2006
Results First Posted : December 17, 2020
Last Update Posted : December 17, 2020
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Pain Intractable Pain Chronic Pain Device: Precision for Spinal Cord Stimulation Not Applicable

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : August 2006
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008
Arms and Interventions
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Arm Intervention/treatment
Experimental: 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)


Outcome Measures
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Primary Outcome Measures :
  1. Percent of Subjects With a Significant Reduction in Pain During the Temporary Trial [ Time Frame: Baseline and at End of trial (approximately 5 days) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00387244


Locations
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United States, California
Spectrum Care
Napa, California, United States, 94558
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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Study Director: Roshini Jain Boston Scientific Neuromodulation Corporation
More Information
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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00387244    
Other Study ID Numbers: SCS0506
First Posted: October 12, 2006    Key Record Dates
Results First Posted: December 17, 2020
Last Update Posted: December 17, 2020
Last Verified: November 2020
Keywords provided by Boston Scientific Corporation:
Pain
Back Pain
Neurostimulation
Additional relevant MeSH terms:
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Chronic Pain
Pain, Intractable
Pain
Neurologic Manifestations