Spinal Cord Stimulation for Predominant Low Back Pain (PROMISE)

Prospective, Randomized Study of Multicolumn Implantable Lead Stimulation for Predominant Low Back Pain

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).

Study Overview

• Status: Completed
• Conditions: Back Pain; Failed Back Surgery Syndrome; Pain in Leg, Unspecified
• Intervention / Treatment: Device: Spinal Cord Stimulation (SCS); Drug: Optimal Medical Management (OMM)

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 Type: Interventional
• Enrollment (Actual): 278
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1200
    • UCL St. Luc
  • Duffel, Belgium, 2570
    • AZ St. Maarten
  • Liège, Belgium, 4000
    • CHR Citadelle
  • Roeselare, Belgium, 8800
    • Heilig Hart Ziekenhuis
  • Wilrijk, Belgium, 2610
    • Department of Neurosurgery: St. Augustinus Ziekenhuizen
• Canada
  • Regina, Canada, S4P 0W5
    • Regina General Hospital
• Colombia
  • Antioquia
    • Medellin, Antioquia, Colombia
      • Hospital Pablo Tobon Uribe
    • Medellin, Antioquia, Colombia, 050025
      • Clínica Las Américas
    • Rionegro, Antioquia, Colombia, 054047
      • San Vicente Fundación
• France
  • Poitiers Cedex, France, 86021
    • Centre Hospitalier Universitaire de Poitiers
• Germany
  • Görlitz, Germany, 02828
    • Städtisches Klinikum Görlitz gGmbH
• Netherlands
  • Tilburg, Netherlands, 5022 GC
    • St. Elisabeth Ziekenhuis Tilburg
• Spain
  • Valencia, Spain, 46010
    • Hospital Clinico Universitario de Valencia
  • Valladolid, Spain, 47005
    • Hospital Clínico Universitario de Valladolid
• United Kingdom
  • Nottingham, United Kingdom, NG7 2UH
    • Nottingham University Hospital NHS Trust
  • Oxford, United Kingdom, OX3 9DU
    • John Radcliffe Hospital Oxford
• United States
  • Georgia
    • Stockbridge, Georgia, United States, 30281
      • Pain Care LLC
  • Mississippi
    • Ocean Springs, Mississippi, United States, 39564
      • The Neuroscience Center
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • Kozmary Center for Pain Management
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical College
    • New York, New York, United States, 10021-9800
      • Weill Medical College of Cornell University
    • North Syracuse, New York, United States, 13212
      • New York Spine and Wellness Center
    • Rochester, New York, United States, 14618
      • University of Rochester Neurosurgery Partners in Pain Management
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke Spine Center
  • Pennsylvania
    • York, Pennsylvania, United States, 17402
      • WellSpan Interventional Pain Center
  • Texas
    • Sugar Land, Texas, United States, 77478
      • Richmond Bone and Joint Clinic
  • Utah
    • Ogden, Utah, United States, 84403
      • Utah Spine Care
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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	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.; 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.
ACTIVE_COMPARATOR: OMM alone; The investigator and subject will determine an individual Optimal Medical Management (OMM) treatment plan	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare Proportion of Subjects With ≥50% Reduction in Low Back Pain Intensity Between the Treatment Groups	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.	6 months post randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare Change in Low Back Pain Intensity, as Measured by the Numeric Pain Rating Scale (NPRS), Between the Treatment Groups	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.	6 months post randomization
Compare Change in Leg Pain Intensity, as Measured by the NPRS, Between the Treatment Groups	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.	6 months post randomization
Compare Change in Functional Disability, as Measured by the Oswestry Disability Index (ODI), Between the Treatment Groups	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.	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	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.	6 months post randomization

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare Proportion of Subjects With ≥30% Reduction in Low Back Pain Intensity Between the Treatment Groups	This additional analysis was pre-specified to support the analysis of primary objective. The 30% responder which is defined in the following paragraph was considered as clinical relevant to the SCS therapy in back pain. Compare the proportion of subjects with a ≥30% 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 ≥30% reduction in average low back pain were considered as 30% responders.	6 months post randomization

Collaborators and Investigators

• Sponsor: MedtronicNeuro
• Investigators: Study Chair: Philippe Rigoard, MD, PhD, University of Poitiers

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 8, 2013
• Primary Completion (ACTUAL): March 12, 2016
• Study Completion (ACTUAL): June 20, 2017

Study Registration Dates

• First Submitted: September 25, 2012
• First Submitted That Met QC Criteria: September 28, 2012
• First Posted (ESTIMATE): October 2, 2012

Study Record Updates

• Last Update Posted (ACTUAL): July 21, 2017
• Last Update Submitted That Met QC Criteria: June 22, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: back pain; RCT; SCS; FBSS; post laminectomy syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Failed Back Surgery Syndrome
• Other Study ID Numbers: 1665

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be kept confidential by Medtronic and only be shared with study investigators following Medtronic approval of a data request form.