Clinical Trials Directory

Trials / Terminated

TerminatedNCT00370695

Spinal Cord Stimulation for Chronic and Intractable Back Pain

Spinal Cord Stimulation for Chronic and Intractable Back Pain in Patients Who Are Not Surgical Candidates

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
15 (actual)
Sponsor
Boston Scientific Corporation · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DEVICEPrecision Spinal Cord Stimulation SystemStimulation turned on from implant throughout the Study

Timeline

Start date
2006-02-01
Primary completion
2008-07-01
Completion
2008-07-01
First posted
2006-09-01
Last updated
2020-12-17
Results posted
2020-12-17

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00370695. Inclusion in this directory is not an endorsement.