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Spinal Cord Stimulation for Chronic and Intractable Back Pain

Primary Purpose

Back Pain

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Precision Spinal Cord Stimulation System
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Back Pain focused on measuring Chronic back pain, Intractable neuropathic back pain, Lumbar radiculopathy, Spinal cord stimulation

Eligibility Criteria

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

Inclusion Criteria: Have chronic and intractable neuropathic back pain and/or lumbar radiculopathy of moderate to severe intensity and have elected Spinal Cord Stimulation (SCS) as next line of treatment. Be 18 years of age or older. Be an appropriate candidate for the surgical procedures required for SCS implant. 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 had any back or spine surgery. Have any evidence of neurologic instability or any anatomic problem of the spine that requires surgery. Have any other chronic pain conditions likely to confound evaluation of study endpoints. Are a current substance abuser (including alcohol and illicit drugs). Have a significant psychiatric disorder. Have a condition currently requiring or likely to require the use of MRI or diathermy. Have an active implantable device. Are pregnant or lactating or planning to become pregnant in the next year. Have participated in any drug or device trial in the last 4 weeks or plan to participate in any other study during the year.

Sites / Locations

  • Huntley Pain Specialists

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Precision Spinal Cord Stimulation System

Arm Description

Single arm Precision Spinal Cord Stimulation System.

Outcomes

Primary Outcome Measures

The Primary Objective of This Study is to Evaluate Back Pain Severity at 12 Weeks Post-activation as Compared to Baseline.

Secondary Outcome Measures

Full Information

First Posted
August 30, 2006
Last Updated
November 21, 2020
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00370695
Brief Title
Spinal Cord Stimulation for Chronic and Intractable Back Pain
Official Title
Spinal Cord Stimulation for Chronic and Intractable Back Pain in Patients Who Are Not Surgical Candidates
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Terminated
Why Stopped
Insufficient Data Collected
Study Start Date
February 2006 (Actual)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy of spinal cord stimulation (SCS) using the Precision implantable neurostimulation device for chronic and intractable back pain in subjects who are not candidates for surgery or who have chosen to seek alternative therapy.
Detailed Description
Management of symptoms of chronic back pain and/or lumbar radiculopathy is often difficult and inadequate. Current treatment options include pharmacological treatments, physical therapy, nerve blocks, surgical interruption of the pain pathway, or back surgery. Many patients either do not have adequate pain management with conventional treatments or are not able to tolerate the treatments due to significant side effects. Similarly, many patients are either not candidates for surgical interventions, or are unwilling to undergo such procedures. Spinal cord stimulation has proven to be an effective treatment for patients with pain following a failed back surgery, and this study will investigate spinal cord stimulation as a treatment option for the treatment of chronic back pain in patients who have never had back surgery. A successful study outcome will establish spinal cord stimulation as a less-invasive treatment option to be considered prior to surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain
Keywords
Chronic back pain, Intractable neuropathic back pain, Lumbar radiculopathy, Spinal cord stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Precision Spinal Cord Stimulation System
Arm Type
Experimental
Arm Description
Single arm Precision Spinal Cord Stimulation System.
Intervention Type
Device
Intervention Name(s)
Precision Spinal Cord Stimulation System
Intervention Description
Stimulation turned on from implant throughout the Study
Primary Outcome Measure Information:
Title
The Primary Objective of This Study is to Evaluate Back Pain Severity at 12 Weeks Post-activation as Compared to Baseline.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have chronic and intractable neuropathic back pain and/or lumbar radiculopathy of moderate to severe intensity and have elected Spinal Cord Stimulation (SCS) as next line of treatment. Be 18 years of age or older. Be an appropriate candidate for the surgical procedures required for SCS implant. 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 had any back or spine surgery. Have any evidence of neurologic instability or any anatomic problem of the spine that requires surgery. Have any other chronic pain conditions likely to confound evaluation of study endpoints. Are a current substance abuser (including alcohol and illicit drugs). Have a significant psychiatric disorder. Have a condition currently requiring or likely to require the use of MRI or diathermy. Have an active implantable device. Are pregnant or lactating or planning to become pregnant in the next year. Have participated in any drug or device trial in the last 4 weeks or plan to participate in any other study during the year.
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
Huntley Pain Specialists
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States

12. IPD Sharing Statement

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Spinal Cord Stimulation for Chronic and Intractable Back Pain

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