Spinal Cord Stimulation for Predominant Low Back Pain (PROMISE)
This study is currently recruiting participants.
Verified May 2013 by MedtronicNeuro
Sponsor:
MedtronicNeuro
Information provided by (Responsible Party):
MedtronicNeuro
ClinicalTrials.gov Identifier:
NCT01697358
First received: September 25, 2012
Last updated: May 6, 2013
Last verified: May 2013
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Failed Back Surgery Syndrome Back Pain Pain in Leg, Unspecified |
Device: Spinal Cord Stimulation (SCS) Drug: Optimal Medical Management (OMM) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Prospective, Randomized Study of Multicolumn Implantable Lead Stimulation for Predominant Low Back Pain |
Resource links provided by NLM:
Further study details as provided by MedtronicNeuro:
Primary Outcome Measures:
- Compare proportion of subjects with ≥50% reduction in low back pain intensity [ Time Frame: 6 months post randomization ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Changes in pain intensity (measured by the Numeric Pain Rating Scale (NPRS) [ Time Frame: 6 months post randomization ] [ Designated as safety issue: No ]
- Changes in disability (measured by the Oswestry Disability Index (ODI) [ Time Frame: 6 months post randomization ] [ Designated as safety issue: No ]
- Changes in the quality of life (measured by the Short Form Health Survey (SF-36) [ Time Frame: 6 months post randomization ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 300 |
| Study Start Date: | January 2013 |
| Estimated Primary Completion Date: | April 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Spinal Cord Stimulation plus Optimal Medical Management |
Device: Spinal Cord Stimulation (SCS)
Spinal Cord Stimulation (SCS) using the Medtronic Specify 5-6-5 multicolumn surgical lead. Subjects will undergo an SCS screening test and, if successful, an implantable neurostimulation system implant. Any SCS group subject not implanted will continue to be treated with OMM and will be followed as part of the SCS group.
|
| Active Comparator: Optimal Medical Management (OMM) |
Drug: Optimal Medical Management (OMM)
The investigator and subject will determine an individual OMM treatment plan, which should include non-investigational pharmacologic agents and/or therapies.
|
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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01697358
Contacts
| Contact: Christine Greening | medtronicneurotrials@medtronic.com |
Locations
| United States, Mississippi | |
| The Neuroscience Center | Recruiting |
| Ocean Springs, Mississippi, United States, 39564 | |
| Contact: Kimberly Rivers kgoodyear.neuro@gmail.com | |
| Principal Investigator: Bart Edmiston, M.D. | |
| United States, New York | |
| New York Spine and Wellness Center | Recruiting |
| North Syracuse, New York, United States, 13212 | |
| Contact: Victoria DiBiase, RN vdibiase@nyspineandwellness.com | |
| Principal Investigator: Anne Calkins, MD | |
| United States, Pennsylvania | |
| WellSpan Interventional Pain Center | Recruiting |
| York, Pennsylvania, United States, 17402 | |
| Contact: To-Nhu Vu, MD tvu@aayofpa.com | |
| Principal Investigator: To-Nhu Vu, MD | |
| United States, West Virginia | |
| West Virginia University | Not yet recruiting |
| Morgantown, West Virginia, United States, 26506 | |
| Contact: Tammy Clark tclark@hsc.wvu.edu | |
| Principal Investigator: Chong Kim, MD | |
| Belgium | |
| AZ St. Maarten | Recruiting |
| Duffel, Belgium, 2570 | |
| Contact: Johan Vangeneugden, MD johan.vangeneugden@emmaus.be | |
| Principal Investigator: Johan Vangeneugden, MD | |
| CHR Citadelle | Recruiting |
| Liège, Belgium, 4000 | |
| Contact: Jean-Michel Remacle, MD jean.michel.remacle@chrcitadelle.be | |
| Principal Investigator: Jean-Michel Remacle, MD | |
| Heilig Hart Ziekenhuis | Recruiting |
| Roeselare, Belgium, 8800 | |
| Contact: Marc Deruytter, MD mderuytter@hhr.be | |
| Principal Investigator: Marc Deruytter, MD | |
| Department of Neurosurgery: St. Augustinus Ziekenhuizen | Recruiting |
| Wilrijk, Belgium, 2610 | |
| Contact: Tony Van Havenbergh, MD info@neurochirurgiegroep.be | |
| Principal Investigator: Tony Van Havenbergh, MD | |
| France | |
| Centre Hospitalier Universitaire de Poitiers | Recruiting |
| Poitiers Cedex, France, 86021 | |
| Contact: Olivier Monlezun olivier-monlezun@chu-poitiers.fr | |
| Principal Investigator: Philippe Rigoard, MD | |
| Germany | |
| Städtisches Klinikum Görlitz gGmbH | Recruiting |
| Görlitz, Germany, 02828 | |
| Contact: Marcus Eif, MD eif.marcus@Klinikum-Görlitz.de | |
| Principal Investigator: Marcus Eif, MD | |
| Netherlands | |
| St. Elisabeth Ziekenhuis Tilburg | Recruiting |
| Tilburg, Netherlands, 5022 GC | |
| Contact: Jojanneke van Rossum j.v.rossum@elisabeth.nl | |
| Principal Investigator: Frank van Eijs, MD | |
Sponsors and Collaborators
MedtronicNeuro
Investigators
| Study Chair: | Philippe Rigoard, MD, PhD | University of Poitiers |
More Information
No publications provided
| Responsible Party: | MedtronicNeuro |
| ClinicalTrials.gov Identifier: | NCT01697358 History of Changes |
| Other Study ID Numbers: | 1665 |
| Study First Received: | September 25, 2012 |
| Last Updated: | May 6, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by MedtronicNeuro:
|
FBSS post laminectomy syndrome SCS RCT back pain |
Additional relevant MeSH terms:
|
Back Pain Low Back Pain Failed Back Surgery Syndrome Pain Neurologic Manifestations |
Nervous System Diseases Signs and Symptoms Postoperative Complications Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013