Prospective, Randomized Study of Multicolumn Implantable Lead Stimulation for Predominant Low Back Pain
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- MedtronicNeuro
- Enrollment
- 278
- Locations
- 28
- Primary Endpoint
- Compare Proportion of Subjects With ≥50% Reduction in Low Back Pain Intensity Between the Treatment Groups
Study Overview
Brief Summary
The purpose of this study is to compare the effectiveness of spinal cord stimulation (SCS) using the Medtronic Specify® 5-6-5 multicolumn surgical lead plus optimal medical management (OMM) versus OMM alone in patients suffering from predominant low back pain due to failed back surgery syndrome (FBSS).
Detailed Description
The study has a multi-center, prospective, randomized (1:1), open-label, parallel-group design of two alternative treatments:
- SCS group (SCS+OMM)
- OMM group
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •SCS candidate with the Specify 5-6-5 surgical lead
- •Has FBSS and does not require further surgery (defined as persistent or recurrent low back and leg pain of at least 6 months duration following at least one decompression and/or fusion procedure)
- •Average low back pain is ≥ 5 as assessed by the baseline NPRS
- •Average low back pain is greater than leg pain
- •Subject has persistent moderate to severe low back and leg pain despite other treatments
Exclusion Criteria
- •Treated with SCS, subcutaneous or peripheral nerve stimulation, an intrathecal drug delivery system, requires back surgery at the location related to his/her original back pain complaint or experimental therapies
- •Most recent back surgery < 6 months ago
- •Low back pain only (no leg pain)
- •Investigator suspects substance abuse that might confound the study results
- •Radiographic evidence of instability requiring fusion
- •Pain relieved completely by lying down
- •Life expectancy of < 24 months
- •Subject is pregnant or planning to become pregnant during the course of the study
- •Subject is unable to undergo study assessments or complete questionnaires independently
Arms & Interventions
SCS + OMM
Spinal Cord Stimulation (SCS) using the Medtronic Specify 5-6-5 multicolumn surgical lead plus an individual Optimal Medical Management (OMM) treatment plan
Intervention: Spinal Cord Stimulation (SCS) (Device)
SCS + OMM
Spinal Cord Stimulation (SCS) using the Medtronic Specify 5-6-5 multicolumn surgical lead plus an individual Optimal Medical Management (OMM) treatment plan
Intervention: Optimal Medical Management (OMM) (Drug)
OMM alone
The investigator and subject will determine an individual Optimal Medical Management (OMM) treatment plan
Intervention: Optimal Medical Management (OMM) (Drug)
Outcomes
Primary Outcomes
Compare Proportion of Subjects With ≥50% Reduction in Low Back Pain Intensity Between the Treatment Groups
Time Frame: 6 months post randomization
Compare the proportion of subjects with a ≥50% reduction in low back pain intensity, as measured by the NPRS, from baseline to the end of Period I in the SCS group with that in the OMM group. Subjects reported average low back pain using a 11-point NPRS pain diary (0 = no back pain, 10 = worst low back pain imaginable) two times per day for a 7-day period at baseline and prior to 6-month visit. Percent reduction in low back pain intensity was calculated as average NPRS at (6-month visit - baseline) / baseline. Subjects with ≥50% reduction in average low back pain were considered as responders.
Secondary Outcomes
- Compare Change in Low Back Pain Intensity, as Measured by the Numeric Pain Rating Scale (NPRS), Between the Treatment Groups(6 months post randomization)
- Compare Change in Leg Pain Intensity, as Measured by the NPRS, Between the Treatment Groups(6 months post randomization)
- Compare Change in Functional Disability, as Measured by the Oswestry Disability Index (ODI), Between the Treatment Groups(6 months post randomization)
- Compare Change in Quality of Life (QoL), as Measured by the SF-36 Physical Component Summary (PCS), Between the Treatment Groups(6 months post randomization)