Spinal Cord Stimulation for Chronic and Intractable Back Pain
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Spinal Cord Stimulation for Chronic and Intractable Back Pain in Patients Who Are Not Surgical Candidates|
- 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 ] [ Designated as safety issue: No ]
- The secondary objectives of this study are to determine the long-term efficacy of this treatment and the impact of treatment on quality of life and disability measures, medication use, and costs associated with medical interventions and drug use for back [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Cumulative frequency of adverse events [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2006|
|Study Completion Date:||July 2008|
|Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
Active Comparator: Precision Spinal Cord Stimulation System
Single arm Precision Spinal Cord Stimulation System.
Device: Precision Spinal Cord Stimulation System
Stimulation turned on from implant throughout the Study
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.
|United States, California|
|Huntley Pain Specialists|
|San Diego, California, United States, 92108|
|Principal Investigator:||Michael Huntley, MD||Huntley Pain Specialists|