Chronic Pain
Conditions
Keywords
Back Pain, Low Back Pain, Chronic Pain, Spinal Cord Stimulation
Brief summary
The purpose of this study is to assess the acute and chronic effectiveness of the Advanced Bionics Precision(TM) Spinal Cord Stimulation System in subjects with failed back surgery syndrome and associated low back axial pain. Subjects will undergo a temporary or permanent trial to assess their candidacy for placement of an implantable pulse generator. Those who demonstrate a significant clinical reduction in pain will be enrolled in the chronic study. Subjects will be followed for 12 months post implantation to assess the long-term effectiveness of the therapy.
Interventions
Stimulation on throughout study
Sponsors
Boston Scientific Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Eligible for spinal cord stimulation as labeled in the FDA approval for the Precision(R) Spinal Cord Stimulator by Advanced Bionics; 2. Age ≥18 years; 3. Have pain of neuropathic origin; 4. Have chronic pain secondary to surgical spine procedure or intractable low back pain with or without leg pain for at least 3 months and not responding to less invasive clinical procedures.
Exclusion criteria
1\. Enrollment in any research that would conflict with study requirements.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of SCS Stimulation in Reducing Back Pain Associated With Failed Back Surgery Syndrome After 12 Months of Use. | 1 year | Effectiveness of SCS stimulation in reducing back pain associated with Failed Back Surgery Syndrome after 12 months of use as measured by 0 - 10 numerical rating scale (Numerical Rating Scale, NRS), where 0 indicates no pain and 10 indicates pain as bad as you can imagine |
| Effectiveness of SCS Stimulation in Reducing Leg Pain Associated With Failed Back Surgery Syndrome After 12 Months of Use. | 1 year | Effectiveness of SCS stimulation in reducing leg pain associated with Failed Back Surgery Syndrome after 12 months of use as measured by 0 - 10 numerical rating scale (Numerical Rating Scale, NRS), where 0 indicates no pain and 10 indicates pain as bad as you can imagine |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Patients Who Achieve a Significant Clinical Reduction in Back Pain Defined as >50% Reduction in VAS Score With Stimulation Compared With no Stimulation | 1 year |
Countries
United States
Participant flow
Pre-assignment details
Efforts were made but the information is not accessible at this time. Hence assignment not available.
Participants by arm
| Arm | Count |
|---|---|
| Spinal Cord Stimulation Subjects will undergo a temporary or permanent trial to assess their candidacy for placement of an implantable pulse generator. Those who demonstrate a significant clinical reduction in pain will be enrolled in the chronic study. Subjects will be followed for 12 months post implantation to assess the long-term effectiveness of the therapy. | 0 |
| Total | 0 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Region of Enrollment United States | — participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 304 |
| other Total, other adverse events | 0 / 304 |
| serious Total, serious adverse events | 0 / 304 |
Outcome results
Primary
Effectiveness of SCS Stimulation in Reducing Back Pain Associated With Failed Back Surgery Syndrome After 12 Months of Use.
Effectiveness of SCS stimulation in reducing back pain associated with Failed Back Surgery Syndrome after 12 months of use as measured by 0 - 10 numerical rating scale (Numerical Rating Scale, NRS), where 0 indicates no pain and 10 indicates pain as bad as you can imagine
Time frame: 1 year
Population: Efforts were made but the information is not accessible at this time. Hence outcome measures not reported.
Primary
Effectiveness of SCS Stimulation in Reducing Leg Pain Associated With Failed Back Surgery Syndrome After 12 Months of Use.
Effectiveness of SCS stimulation in reducing leg pain associated with Failed Back Surgery Syndrome after 12 months of use as measured by 0 - 10 numerical rating scale (Numerical Rating Scale, NRS), where 0 indicates no pain and 10 indicates pain as bad as you can imagine
Time frame: 1 year
Population: Efforts were made but the information is not accessible at this time. Hence outcome measures not reported.
Secondary
Percentage of Patients Who Achieve a Significant Clinical Reduction in Back Pain Defined as >50% Reduction in VAS Score With Stimulation Compared With no Stimulation
Time frame: 1 year
Population: Efforts were made but the information is not accessible at this time. Hence outcome measures not reported.