Failed Back Surgery SyndromePhase 4PROMISENCT01697358
Spinal Cord Stimulation for Predominant Low Back Pain
A Phase 4 study testing Spinal Cord Stimulation (SCS) and Optimal Medical Management (OMM) in people with Failed Back Surgery Syndrome and Back Pain, run by MedtronicNeuro at 28 sites in 9 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Failed Back Surgery Syndrome, Back Pain, Pain in Leg, Unspecified
- What is being tested?
- Spinal Cord Stimulation (SCS) and Optimal Medical Management (OMM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 278 participants
- Where
- 28 sitesin 9 countries
- Study dates
- 8 Jan 2013to 20 Jun 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
28 sites in 9 countries.
28 sites in 9 countries
United States12 sites
Albany Medical College
Albany, New York, 12208
Duke Spine Center
Durham, North Carolina, 27710
Kozmary Center for Pain Management
Las Vegas, Nevada, 89102
West Virginia University
Morgantown, West Virginia, 26506
Weill Medical College of Cornell University
New York, New York, 10021-9800
New York Spine and Wellness Center
North Syracuse, New York, 13212
The Neuroscience Center
Ocean Springs, Mississippi, 39564
Utah Spine Care
Ogden, Utah, 84403
University of Rochester Neurosurgery Partners in Pain Management
Rochester, New York, 14618
Pain Care LLC
Stockbridge, Georgia, 30281
Richmond Bone and Joint Clinic
Sugar Land, Texas, 77478
WellSpan Interventional Pain Center
York, Pennsylvania, 17402
Belgium5 sites
UCL St. Luc
Brussels, 1200
AZ St. Maarten
Duffel, 2570
CHR Citadelle
Liège, 4000
Heilig Hart Ziekenhuis
Roeselare, 8800
Department of Neurosurgery: St. Augustinus Ziekenhuizen
Wilrijk, 2610
Colombia3 sites
Clínica Las Américas
Medellín, Antioquia, 050025
Hospital Pablo Tobón Uribe
Medellín, Antioquia
San Vicente Fundación
Rionegro, Antioquia, 054047
Spain2 sites
Hospital Clinico Universitario de Valencia
Valencia, 46010
Hospital Clínico Universitario de Valladolid
Valladolid, 47005
United Kingdom2 sites
Nottingham University Hospital NHS Trust
Nottingham, NG7 2UH
John Radcliffe Hospital Oxford
Oxford, OX3 9DU
About this study
Official title: 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).
Read the 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
- Being tested
- Spinal Cord Stimulation (SCS), Optimal Medical Management (OMM)
- Keywords
- FBSS, post laminectomy syndrome, SCS, RCT, back pain
- Medical subject headings
- Failed Back Surgery Syndrome, Back Pain, post laminectomy syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Cord Stimulation (SCS)Device
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.
Optimal Medical Management (OMM)Drug
The investigator and subject will determine an individual OMM treatment plan, which should include non-investigational pharmacologic agents and/or therapies.
| Study group | Role | What they receive |
|---|---|---|
| SCS + OMM | Active comparator | Spinal Cord Stimulation (SCS) using the Medtronic Specify 5-6-5 multicolumn surgical lead plus an individual Optimal Medical Management (OMM) treatment plan Receives: Device: Spinal Cord Stimulation (SCS); Drug: Optimal Medical Management (OMM) |
| OMM alone | Active comparator | The investigator and subject will determine an individual Optimal Medical Management (OMM) treatment plan Receives: Drug: Optimal Medical Management (OMM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months post randomization
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2012 (estimated)
- Study start8 Jan 2013
- Primary completion12 Mar 2016
- Study completion20 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Failed Back Surgery SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedtronicNeuro
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philippe Rigoard, MD, PhD, Study chair, University of Poitiers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01697358
- Sponsor's protocol ID
- 1665
- Acronym
- PROMISE
- Status last verified
- Jun 2017
- First submitted
- 25 Sep 2012
- Last updated
- 21 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: Data will be kept confidential by Medtronic and only be shared with study investigators following Medtronic approval of a data request form.
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.
PubMed 34854473Rigoard 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.
PubMed 30720582Rigoard 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.
PubMed 24195916
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized Study of Multicolumn Implantable Lead Stimulation for Predominant Low Back Pain
- ClinicalTrials.gov ID
- NCT01697358
- Acronym / sponsor ID
- PROMISE / 1665
- Keywords
- FBSS, post laminectomy syndrome, SCS, RCT, back pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- MedtronicNeuroIndustry (pharma, biotech, devices)
- Study start
- 8 Jan 2013 (actual)
- Primary completion
- 12 Mar 2016 (actual)
- Study completion
- 20 Jun 2017 (actual)
- First posted
- 2 Oct 2012 (estimated)
- Results
- Posted 14 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| SCS + OMM | Active comparator | Device: Spinal Cord Stimulation (SCS), Drug: 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 |
| OMM alone | Active comparator | Drug: Optimal Medical Management (OMM)The investigator and subject will determine an individual Optimal Medical Management (OMM) treatment plan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | SCS + OMM |
| 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. | Drug | OMM alone, SCS + OMM |
Primary outcome
Compare Proportion of Subjects With ≥50% Reduction in Low Back Pain Intensity Between the Treatment Groups
Time frame: 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.
4 secondary outcomes
Compare Change in Low Back Pain Intensity, as Measured by the Numeric Pain Rating Scale (NPRS), Between the Treatment Groups
Time frame: 6 months post randomization
Compare Change in Leg Pain Intensity, as Measured by the NPRS, Between the Treatment Groups
Time frame: 6 months post randomization
Compare Change in Functional Disability, as Measured by the Oswestry Disability Index (ODI), Between the Treatment Groups
Time frame: 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
Time frame: 6 months post randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34854473O'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.
- Derived from this study: PubMed 30720582Rigoard 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.
- Derived from this study: PubMed 24195916Rigoard 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.
- Individual participant dataSharing planned: No. Data will be kept confidential by Medtronic and only be shared with study investigators following Medtronic approval of a data request form.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Rigoard, MD, PhD study chair
University of Poitiers
28 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Spinal Cord Stimulation (SCS) and Optimal Medical Management (OMM) in people with Failed Back Surgery Syndrome and Back Pain, run by MedtronicNeuro at 28 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, Belgium, Colombia, Spain, United Kingdom and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare Proportion of Subjects With ≥50% Reduction in Low Back Pain Intensity Between the Treatment Groups (time frame: 6 months post randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01697358, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2017.