Clinical trial NCT01697358: Spinal Cord Stimulation for Predominant Low Back Pain
Official title: Prospective, Randomized Study of Multicolumn Implantable Lead Stimulation for Predominant Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Failed Back Surgery Syndrome
Back Pain
Pain in Leg, Unspecified
Keywords: FBSS
post laminectomy syndrome
SCS
RCT
back pain
Lead sponsor: MedtronicNeuro
Sponsor class: INDUSTRY
First posted: 2012-10-02
Enrollment: 278
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Period I (from randomization to 6 months) is the randomized parallel group comparative phase. Day zero for the study is the point of randomization. The randomization ratio is 1:1 (SCS+OMM to OMM). For the SCS+OMM arm, the screening test and/or implant occurred after randomization. Period II (6 to 24 months) is the long-term observational follow-up phase.
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Compare Proportion of Subjects With ≥50% Reduction in Low Back Pain Intensity Between the Treatment Groups
timeFrame: 6 months post randomization
Secondary outcomes:
measure: Compare Change in Low Back Pain Intensity, as Measured by the Numeric Pain Rating Scale (NPRS), Between the Treatment Groups
timeFrame: 6 months post randomization
measure: Compare Change in Leg Pain Intensity, as Measured by the NPRS, Between the Treatment Groups
timeFrame: 6 months post randomization
measure: Compare Change in Functional Disability, as Measured by the Oswestry Disability Index (ODI), Between the Treatment Groups
timeFrame: 6 months post randomization
measure: Compare Change in Quality of Life (QoL), as Measured by the SF-36 Physical Component Summary (PCS), Between the Treatment Groups
timeFrame: 6 months post randomization
Other outcomes:
measure: Compare Proportion of Subjects With ≥30% Reduction in Low Back Pain Intensity Between the Treatment Groups
timeFrame: 6 months post randomization
Locations:
city: Stockbridge
country: United States
facility: Pain Care LLC
state: Georgia
city: Ocean Springs
country: United States
facility: The Neuroscience Center
state: Mississippi
city: Las Vegas
country: United States
facility: Kozmary Center for Pain Management
state: Nevada
city: Albany
country: United States
facility: Albany Medical College
state: New York
city: New York
country: United States
facility: Weill Medical College of Cornell University
state: New York
city: North Syracuse
country: United States
facility: New York Spine and Wellness Center
state: New York
city: Rochester
country: United States
facility: University of Rochester Neurosurgery Partners in Pain Management
state: New York
city: Durham
country: United States
facility: Duke Spine Center
state: North Carolina
city: York
country: United States
facility: WellSpan Interventional Pain Center
state: Pennsylvania
city: Sugar Land
country: United States
facility: Richmond Bone and Joint Clinic
state: Texas
city: Ogden
country: United States
facility: Utah Spine Care
state: Utah
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
city: Brussels
country: Belgium
facility: UCL St. Luc
city: Duffel
country: Belgium
facility: AZ St. Maarten
city: Liège
country: Belgium
facility: CHR Citadelle
city: Roeselare
country: Belgium
facility: Heilig Hart Ziekenhuis
city: Wilrijk
country: Belgium
facility: Department of Neurosurgery: St. Augustinus Ziekenhuizen
city: Regina
country: Canada
facility: Regina General Hospital
city: Medellin
country: Colombia
facility: Clínica Las Américas
state: Antioquia
city: Medellin
country: Colombia
facility: Hospital Pablo Tobón Uribe
state: Antioquia
city: Rionegro
country: Colombia
facility: San Vicente Fundación
state: Antioquia
city: Poitiers Cedex
country: France
facility: Centre Hospitalier Universitaire de Poitiers
city: Görlitz
country: Germany
facility: Städtisches Klinikum Görlitz gGmbH
city: Tilburg
country: Netherlands
facility: St. Elisabeth Ziekenhuis Tilburg
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospital NHS Trust
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital Oxford
Study officials:
affiliation: University of Poitiers
name: Philippe Rigoard, MD, PhD
role: STUDY_CHAIR
References:
citation: O'Connell NE, Ferraro MC, Gibson W, Rice AS, Vase L, Coyle D, Eccleston C. Implanted spinal neuromodulation interventions for chronic pain in adults. Cochrane Database Syst Rev. 2021 Dec 2;12(12):CD013756. doi: 10.1002/14651858.CD013756.pub2.
citation: Rigoard P, Basu S, Desai M, Taylor R, Annemans L, Tan Y, Johnson MJ, Van den Abeele C, North R; PROMISE Study Group. Multicolumn spinal cord stimulation for predominant back pain in failed back surgery syndrome patients: a multicenter randomized controlled trial. Pain. 2019 Jun;160(6):1410-1420. doi: 10.1097/j.pain.0000000000001510.
citation: Rigoard P, Desai MJ, North RB, Taylor RS, Annemans L, Greening C, Tan Y, Van den Abeele C, Shipley J, Kumar K. Spinal cord stimulation for predominant low back pain in failed back surgery syndrome: study protocol for an international multicenter randomized controlled trial (PROMISE study). Trials. 2013 Nov 7;14:376. doi: 10.1186/1745-6215-14-376.