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Efficacy of the Spinal Cord Stimulation System as Salvage Therapy

Primary Purpose

Pain, Intractable Pain, Chronic Pain

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Precision for Spinal Cord Stimulation

About this trial

This is an interventional treatment trial for Pain focused on measuring Pain, Back Pain, Neurostimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Spectrum Care

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Precision for Spinal Cord Stimulation

Arm Description

Single arm Precision for Spinal Cord Stimulation

Outcomes

Primary Outcome Measures

Percent of Subjects With a Significant Reduction in Pain During the Temporary Trial

Secondary Outcome Measures

Full Information

NCT ID

NCT00387244

First Posted

October 10, 2006

Last Updated

November 21, 2020

Sponsor

Boston Scientific Corporation

1. Study Identification

Unique Protocol Identification Number

NCT00387244

Brief Title

Efficacy of the Spinal Cord Stimulation System as Salvage Therapy

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Terminated

Why Stopped

Insufficient Data Collected

Study Start Date

August 2006 (Actual)

Primary Completion Date

April 2008 (Actual)

Study Completion Date

April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boston Scientific Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Intractable Pain, Chronic Pain

Keywords

Pain, Back Pain, Neurostimulation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Precision for Spinal Cord Stimulation

Arm Type

Experimental

Arm Description

Single arm Precision for Spinal Cord Stimulation

Intervention Type

Device

Intervention Name(s)

Precision for Spinal Cord Stimulation

Other Intervention Name(s)

PRECISION Spinal Cord Stimulator System (Precision System)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Percent of Subjects With a Significant Reduction in Pain During the Temporary Trial

Time Frame

Baseline and at End of trial (approximately 5 days)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Roshini Jain

Organizational Affiliation

Boston Scientific Neuromodulation Corporation

Official's Role

Study Director

Facility Information:

Facility Name

Spectrum Care

City

Napa

State/Province

California

ZIP/Postal Code

94558

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Efficacy of the Spinal Cord Stimulation System as Salvage Therapy

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