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Spinal Cord Stimulation for Predominant Low Back Pain (PROMISE)

Primary Purpose

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

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Spinal Cord Stimulation (SCS)
Optimal Medical Management (OMM)
Sponsored by
MedtronicNeuro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Failed Back Surgery Syndrome focused on measuring FBSS, post laminectomy syndrome, SCS, RCT, back pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pain Care LLC
  • The Neuroscience Center
  • Kozmary Center for Pain Management
  • Albany Medical College
  • Weill Medical College of Cornell University
  • New York Spine and Wellness Center
  • University of Rochester Neurosurgery Partners in Pain Management
  • Duke Spine Center
  • WellSpan Interventional Pain Center
  • Richmond Bone and Joint Clinic
  • Utah Spine Care
  • West Virginia University
  • UCL St. Luc
  • AZ St. Maarten
  • CHR Citadelle
  • Heilig Hart Ziekenhuis
  • Department of Neurosurgery: St. Augustinus Ziekenhuizen
  • Regina General Hospital
  • Clínica Las Américas
  • Hospital Pablo Tobón Uribe
  • San Vicente Fundación
  • Centre Hospitalier Universitaire de Poitiers
  • Städtisches Klinikum Görlitz gGmbH
  • St. Elisabeth Ziekenhuis Tilburg
  • Hospital Clinico Universitario de Valencia
  • Hospital Clínico Universitario de Valladolid
  • Nottingham University Hospital NHS Trust
  • John Radcliffe Hospital Oxford

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

SCS + OMM

OMM alone

Arm Description

Spinal Cord Stimulation (SCS) using the Medtronic Specify 5-6-5 multicolumn surgical lead plus an individual Optimal Medical Management (OMM) treatment plan

The investigator and subject will determine an individual Optimal Medical Management (OMM) treatment plan

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
September 25, 2012
Last Updated
June 22, 2017
Sponsor
MedtronicNeuro
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1. Study Identification

Unique Protocol Identification Number
NCT01697358
Brief Title
Spinal Cord Stimulation for Predominant Low Back Pain
Acronym
PROMISE
Official Title
Prospective, Randomized Study of Multicolumn Implantable Lead Stimulation for Predominant Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
January 8, 2013 (Actual)
Primary Completion Date
March 12, 2016 (Actual)
Study Completion Date
June 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MedtronicNeuro

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Failed Back Surgery Syndrome, Back Pain, Pain in Leg, Unspecified
Keywords
FBSS, post laminectomy syndrome, SCS, RCT, back pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
278 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SCS + OMM
Arm Type
Active Comparator
Arm Description
Spinal Cord Stimulation (SCS) using the Medtronic Specify 5-6-5 multicolumn surgical lead plus an individual Optimal Medical Management (OMM) treatment plan
Arm Title
OMM alone
Arm Type
Active Comparator
Arm Description
The investigator and subject will determine an individual Optimal Medical Management (OMM) treatment plan
Intervention Type
Device
Intervention Name(s)
Spinal Cord Stimulation (SCS)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Optimal Medical Management (OMM)
Intervention Description
The investigator and subject will determine an individual OMM treatment plan, which should include non-investigational pharmacologic agents and/or therapies.
Primary Outcome Measure Information:
Title
Compare Proportion of Subjects With ≥50% Reduction in Low Back Pain Intensity Between the Treatment Groups
Description
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.
Time Frame
6 months post randomization
Secondary Outcome Measure Information:
Title
Compare Change in Low Back Pain Intensity, as Measured by the Numeric Pain Rating Scale (NPRS), Between the Treatment Groups
Description
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.
Time Frame
6 months post randomization
Title
Compare Change in Leg Pain Intensity, as Measured by the NPRS, Between the Treatment Groups
Description
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.
Time Frame
6 months post randomization
Title
Compare Change in Functional Disability, as Measured by the Oswestry Disability Index (ODI), Between the Treatment Groups
Description
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.
Time Frame
6 months post randomization
Title
Compare Change in Quality of Life (QoL), as Measured by the SF-36 Physical Component Summary (PCS), Between the Treatment Groups
Description
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.
Time Frame
6 months post randomization
Other Pre-specified Outcome Measures:
Title
Compare Proportion of Subjects With ≥30% Reduction in Low Back Pain Intensity Between the Treatment Groups
Description
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.
Time Frame
6 months post randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Rigoard, MD, PhD
Organizational Affiliation
University of Poitiers
Official's Role
Study Chair
Facility Information:
Facility Name
Pain Care LLC
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
The Neuroscience Center
City
Ocean Springs
State/Province
Mississippi
ZIP/Postal Code
39564
Country
United States
Facility Name
Kozmary Center for Pain Management
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Albany Medical College
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Weill Medical College of Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10021-9800
Country
United States
Facility Name
New York Spine and Wellness Center
City
North Syracuse
State/Province
New York
ZIP/Postal Code
13212
Country
United States
Facility Name
University of Rochester Neurosurgery Partners in Pain Management
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Duke Spine Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
WellSpan Interventional Pain Center
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17402
Country
United States
Facility Name
Richmond Bone and Joint Clinic
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77478
Country
United States
Facility Name
Utah Spine Care
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Facility Name
West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
UCL St. Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
AZ St. Maarten
City
Duffel
ZIP/Postal Code
2570
Country
Belgium
Facility Name
CHR Citadelle
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Heilig Hart Ziekenhuis
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
Department of Neurosurgery: St. Augustinus Ziekenhuizen
City
Wilrijk
ZIP/Postal Code
2610
Country
Belgium
Facility Name
Regina General Hospital
City
Regina
ZIP/Postal Code
S4P 0W5
Country
Canada
Facility Name
Clínica Las Américas
City
Medellin
State/Province
Antioquia
ZIP/Postal Code
050025
Country
Colombia
Facility Name
Hospital Pablo Tobón Uribe
City
Medellin
State/Province
Antioquia
Country
Colombia
Facility Name
San Vicente Fundación
City
Rionegro
State/Province
Antioquia
ZIP/Postal Code
054047
Country
Colombia
Facility Name
Centre Hospitalier Universitaire de Poitiers
City
Poitiers Cedex
ZIP/Postal Code
86021
Country
France
Facility Name
Städtisches Klinikum Görlitz gGmbH
City
Görlitz
ZIP/Postal Code
02828
Country
Germany
Facility Name
St. Elisabeth Ziekenhuis Tilburg
City
Tilburg
ZIP/Postal Code
5022 GC
Country
Netherlands
Facility Name
Hospital Clinico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Hospital Clínico Universitario de Valladolid
City
Valladolid
ZIP/Postal Code
47005
Country
Spain
Facility Name
Nottingham University Hospital NHS Trust
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Facility Name
John Radcliffe Hospital Oxford
City
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data will be kept confidential by Medtronic and only be shared with study investigators following Medtronic approval of a data request form.
Citations:
PubMed Identifier
34854473
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.
Results Reference
derived
PubMed Identifier
30720582
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.
Results Reference
derived
PubMed Identifier
24195916
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.
Results Reference
derived

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Spinal Cord Stimulation for Predominant Low Back Pain

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