Back Pain
Conditions
Keywords
Chronic back pain, Intractable neuropathic back pain, Lumbar radiculopathy, Spinal cord stimulation
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.
Interventions
Stimulation turned on from implant throughout the Study
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Primary Objective of This Study is to Evaluate Back Pain Severity at 12 Weeks Post-activation as Compared to Baseline. | 12 weeks |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Precision Spinal Cord Stimulation System Single arm Precision Spinal Cord Stimulation System.
Precision Spinal Cord Stimulation System: Stimulation turned on from implant throughout the Study | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | Precision Spinal Cord Stimulation System |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Region of Enrollment United States | 15 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 2 / 15 |
| serious Total, serious adverse events | 3 / 15 |
Outcome results
Primary
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
Population: The study was terminated and efforts were made to locate data. No study data are available.