Spinal Cord Stimulation for Chronic and Intractable Back Pain

NCT ID: NCT00370695

Last Updated: 2020-12-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2008-07-31

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.

Conditions

Back Pain

Keywords

Chronic back pain; Intractable neuropathic back pain; Lumbar radiculopathy; Spinal cord stimulation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Precision Spinal Cord Stimulation System

Single arm Precision Spinal Cord Stimulation System.

Group Type: EXPERIMENTAL

Precision Spinal Cord Stimulation System

Intervention Type: DEVICE

Stimulation turned on from implant throughout the Study

Interventions

Precision Spinal Cord Stimulation System

Stimulation turned on from implant throughout the Study

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roshini Jain

Role: STUDY_DIRECTOR

Boston Scientific Neuromodulation Corporation

Locations

Huntley Pain Specialists

San Diego, California, United States

Countries

United States

Other Identifiers

SCS-03-05

Identifier Type: -

Identifier Source: org_study_id