Phase 4
N=218
Spinal Cord Stimulation for Predominant Low Back Pain
Failed Back Surgery Syndrome · Back Pain · Pain in Leg, Unspecified
Bottom Line
View on ClinicalTrials.gov: NCT01697358 ↗Enrolled (actual)
218
Serious AEs
11.5%
Results posted
Jun 2017
Primary outcome: Primary: Compare Proportion of Subjects With ≥50% Reduction in Low Back Pain Intensity Between the Treatment Groups — 15; 5 Participants — p=0.036
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Spinal Cord Stimulation (SCS) (Device); Optimal Medical Management (OMM) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- MedtronicNeuro
- Primary completion
- Mar 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Compare Proportion of Subjects With ≥50% Reduction in Low Back Pain Intensity Between the Treatment Groups |
15; 5 | 0.036 sig |
| SECONDARY Compare Change in Low Back Pain Intensity, as Measured by the Numeric Pain Rating Scale (NPRS), Between the Treatment Groups |
1.4; 0.3 | < 0.001 sig |
| SECONDARY Compare Change in Leg Pain Intensity, as Measured by the NPRS, Between the Treatment Groups |
1.2; -0.1 | < 0.001 sig |
| SECONDARY Compare Change in Functional Disability, as Measured by the Oswestry Disability Index (ODI), Between the Treatment Groups |
8.1; 1.8 | < 0.001 sig |
| SECONDARY Compare Change in Quality of Life (QoL), as Measured by the SF-36 Physical Component Summary (PCS), Between the Treatment Groups |
5.27; 1.34 | < 0.001 sig |
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01697358). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.