Spinal Cord Stimulation for Predominant Low Back Pain

Phase 4

Completed

Conditions: Failed Back Surgery Syndrome
Back Pain
Pain in Leg, Unspecified

Interventions: Device: Spinal Cord Stimulation (SCS)
Drug: Optimal Medical Management (OMM)

Registration Number: NCT01697358

Lead Sponsor: MedtronicNeuro

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 278

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SCS + OMM	Optimal Medical Management (OMM)	Spinal Cord Stimulation (SCS) using the Medtronic Specify 5-6-5 multicolumn surgical lead plus an individual Optimal Medical Management (OMM) treatment plan
SCS + OMM	Spinal Cord Stimulation (SCS)	Spinal Cord Stimulation (SCS) using the Medtronic Specify 5-6-5 multicolumn surgical lead plus an individual Optimal Medical Management (OMM) treatment plan
OMM alone	Optimal Medical Management (OMM)	The investigator and subject will determine an individual Optimal Medical Management (OMM) treatment plan

Primary Outcome Measures

Name	Time	Method
Compare Proportion of Subjects With ≥50% Reduction in Low Back Pain Intensity Between the Treatment Groups	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 Outcome Measures

Name	Time	Method
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 low back pain intensity, as measured by the Numeric Pain Rating Scale (NPRS), from baseline to the end of Period I for subjects 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. Change in low back pain intensity is calculated as NPRS at baseline - NPRS at 6-month visit, with a positive change indicated as an improvement.
Compare Change in Leg Pain Intensity, as Measured by the NPRS, Between the Treatment Groups	6 months post randomization	Compare change in leg pain intensity, as measured by the NPRS, from baseline to the end of Period I for subjects in the SCS group with that in the OMM group. Subjects reported average leg 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. Change in leg pain intensity is calculated as NPRS at baseline - NPRS at 6-month visit, with a positive change indicated as an improvement.
Compare Change in Functional Disability, as Measured by the Oswestry Disability Index (ODI), Between the Treatment Groups	6 months post randomization	ODI is a validated questionnaire of 10 subject-reported sections on the ability to perform activities of daily living. These 10 sections are pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life (if applicable), social life, and traveling. Each section was scored on a 0 to 5 scale with 0 indicating no limitation of function due to pain and 5 indicating major functional disability due to back pain. A raw ODI score was calculated from the total score of 10 sections (minimum is 0 and maximum is 50). This ODI raw score was then normalized to a scale of 0 to 100, with 0-20 categorized as minimal disability, 20-40 as moderate disability, 40-60 as severe disability, 60-80 as severely disabled, and 80-100 as bed-bound patients. The ODI was assessed at baseline and subsequent scheduled study visits. Change in functional disability is calculated as ODI at baseline - ODI at 6-month visit, with a positive change indicated as an improvement.
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	The QoL scores were collected using the SF-36 questionnaire, which included the scores in the following 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health. The raw score of 0 represents poor health and 100 represents best health. The Physical Component Summary (PCS) score is a norm based score calculated from the raw scores of these 8 domains with a focus on physical health using 1998 US population. Change in PCS is calculated as PCS at 6-month visit - PCS at baseline, with a positive change indicated as an improvement.

Trial Locations

Locations (28): The Neuroscience Center
🇺🇸
Ocean Springs, Mississippi, United States
UCL St. Luc
🇧🇪
Brussels, Belgium
Heilig Hart Ziekenhuis
🇧🇪
Roeselare, Belgium
WellSpan Interventional Pain Center
🇺🇸
York, Pennsylvania, United States
Richmond Bone and Joint Clinic
🇺🇸
Sugar Land, Texas, United States
Utah Spine Care
🇺🇸
Ogden, Utah, United States
West Virginia University
🇺🇸
Morgantown, West Virginia, United States
Pain Care LLC
🇺🇸
Stockbridge, Georgia, United States
AZ St. Maarten
🇧🇪
Duffel, Belgium
Clínica Las Américas
🇨🇴
Medellin, Antioquia, Colombia
Hospital Pablo Tobón Uribe
🇨🇴
Medellin, Antioquia, Colombia
John Radcliffe Hospital Oxford
🇬🇧
Oxford, United Kingdom
Weill Medical College of Cornell University
🇺🇸
New York, New York, United States
CHR Citadelle
🇧🇪
Liège, Belgium
Department of Neurosurgery: St. Augustinus Ziekenhuizen
🇧🇪
Wilrijk, Belgium
St. Elisabeth Ziekenhuis Tilburg
🇳🇱
Tilburg, Netherlands
Centre Hospitalier Universitaire de Poitiers
🇫🇷
Poitiers Cedex, France
Regina General Hospital
🇨🇦
Regina, Canada
New York Spine and Wellness Center
🇺🇸
North Syracuse, New York, United States
Albany Medical College
🇺🇸
Albany, New York, United States
San Vicente Fundación
🇨🇴
Rionegro, Antioquia, Colombia
University of Rochester Neurosurgery Partners in Pain Management
🇺🇸
Rochester, New York, United States
Hospital Clinico Universitario de Valencia
🇪🇸
Valencia, Spain
Städtisches Klinikum Görlitz gGmbH
🇩🇪
Görlitz, Germany
Nottingham University Hospital NHS Trust
🇬🇧
Nottingham, United Kingdom
Hospital Clínico Universitario de Valladolid
🇪🇸
Valladolid, Spain
Kozmary Center for Pain Management
🇺🇸
Las Vegas, Nevada, United States
Duke Spine Center
🇺🇸
Durham, North Carolina, United States