Failed Back Surgery SyndromePROMISENCT05466110
Spinal Cord Stimulation Versus Instrumentation for FBSS
A study testing Spinal Cord Stimulation and Spinal Fusion Surgery in people with Failed Back Surgery Syndrome and SCS, run by University Hospital Augsburg at 1 site in Germany.
Trial summary
Low back pain affects people of all ages and has become the leading cause of living with disability worldwide. Patients, suffering from persistent pain after spinal surgery in the absence of any clear spinal pathology are defined of having a "failed back surgery syndrome (FBSS)" and treatment of FBSS remains a great… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Failed Back Surgery Syndrome, SCS, Neuromodulation
- What is being tested?
- Spinal Cord Stimulation and Spinal Fusion Surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteGermany
- Study dates
- 20 Mar 2023to May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Age ≥18 years
- Symptomatic degenerative disc disease with LBP as a predominant symptom for at least 6 months following pervious surgery for disc herniation
- ODI score at least 21
- Correctly signed informed consent form
Who cannot join
- Spinal stenosis resulting in spinal claudication or neurological deficits
- Spinal Instability (> 3 mm Motion on dynamic Lumbar X-rays)
- Major psychiatric disorder
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Augsburg Department of Neurosurgery
Augsburg, Bavaria, 86156
Ehab Shiban, MD, Ehab.shiban@uk-augsburg.de
Philipp Krauss, MD, philippemanuel.krauss@uk-augsburg.de
About this study
Official title: sPinal coRd stimulatiOn coMpared With Lumbar InStrumEntation for Low Back Pain After Previous Lumbar Decompression (PROMISE): a Prospective Randomized Controlled Study
Low back pain affects people of all ages and has become the leading cause of living with disability worldwide. Patients, suffering from persistent pain after spinal surgery in the absence of any clear spinal pathology are defined of having a "failed back surgery syndrome (FBSS)" and treatment of FBSS remains a great controversy in the spinal community. Apart from conservative treatment, spinal fusion remains as therapeutic option. Furthermore, minimal invasive Neuromodulation techniques might be a promising alternative. Aim of this randomized interventional multi center study is to compare treatment success in FBSS patients with either spinal cord stimulation (SCS) or fusion surgery, 12 months after intervention according to the Oswestry Disability Index (ODI) and other scales and scores. Radiological and health economic outcome also will be analysed for thorough comparison of techniques. Additionally, the safety of the interventions needs to be compared.
- Conditions
- Failed Back Surgery Syndrome, SCS, Neuromodulation, Spinal Cord Stimulation, Spinal Fusion, Low Back Pain
- Being tested
- Spinal Cord Stimulation, Spinal Fusion Surgery
- Medical subject headings
- Failed Back Surgery Syndrome, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Cord StimulationDevice
Also called SCS
Epidural application of electrical current to the spinal cord
Spinal Fusion SurgeryProcedure or surgery
screw-rod system based spinal instrumentation
| Study group | Role | What they receive |
|---|---|---|
| Spinal Cord Stimulation Device | Experimental | The spinal cord stimulators WaveWriter AlphaTM (Boston Scientific) are designed to treat chronic back or leg pain by electrically stimulating the spinal cord. It is a well established worldwide licensed device. Percutaneous lead(-s) are implanted in the epidural space of the thoracic spine during the initial procedure. After discharge a trial phase is initiated and performed according to local preferences and standard of operations (SOPs). Patients are monitored for any complications and pain reduction. If a significant pain reduction (>50 % on the NRS scale for back pain) is achieved, the permanent implantable pulse generator (IPG) is implanted. Otherwise if the therapy remains non-beneficial throughout the trial phase, the leads will be explanted. Patients are allowed to crossover in the fusion group at any point of time. Receives: Device: Spinal Cord Stimulation |
| Control - Lumbar Fusion surgery | Active comparator | The control group needs to represent the standard of care of current practice. Gold standard is lumbar fusion surgery [Resnik 2005]. Surgical instrumentation will be performed according to local preferences and SOPs. Safety and efficacy of these fusion techniques have been repeatedly proven Receives: Procedure: Spinal Fusion Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry disability index / ODI
A patient reported outcome measure to rate pain and disability
Measured: 12 months after intervention
Secondary outcomes (6)
Adverse events
Comparison of complication rates
Measured: 12 months after intervention
SF36
Score to assess quality of life
Measured: 12 months after intervention
EuroQOL 5D
Score to assess quality of life
Measured: 12 months after intervention
hospital length of stay
Time measured in days, counting from the first day of hospitalization until the day of discharge of the hospitalization the surgical intervention was performed. If surgery is performed as staged procedure in two separate hospitalizations (SCS) both hospitalizations are counted as described above and days are summed up.
Measured: through study completion, an average of 2 years
Crossover rates
Rates of crossover to another therapy arm
Measured: 12 months after intervention
Pain medication
Amount of analgesics taken (drug, dose, mode of application)
Measured: 12 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start20 Mar 2023
- Primary completionNov 2024 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Augsburg
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05466110
- Sponsor's protocol ID
- 22-0221
- Acronym
- PROMISE
- Status last verified
- Apr 2022
- First submitted
- 25 Apr 2022
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Resnick DK, Choudhri TF, Dailey AT, Groff MW, Khoo L, Matz PG, Mummaneni P, Watters WC 3rd, Wang J, Walters BC, Hadley MN; American Association of Neurological Surgeons/Congress of Neurological Surgeons. Guidelines for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 10: fusion following decompression in patients with stenosis without spondylolisthesis. J Neurosurg Spine. 2005 Jun;2(6):686-91. doi: 10.3171/spi.2005.2.6.0686.
PubMed 16028738Brox JI, Sorensen R, Friis A, Nygaard O, Indahl A, Keller A, Ingebrigtsen T, Eriksen HR, Holm I, Koller AK, Riise R, Reikeras O. Randomized clinical trial of lumbar instrumented fusion and cognitive intervention and exercises in patients with chronic low back pain and disc degeneration. Spine (Phila Pa 1976). 2003 Sep 1;28(17):1913-21. doi: 10.1097/01.BRS.0000083234.62751.7A.
PubMed 12973134Fritzell P, Hagg O, Wessberg P, Nordwall A; Swedish Lumbar Spine Study Group. 2001 Volvo Award Winner in Clinical Studies: Lumbar fusion versus nonsurgical treatment for chronic low back pain: a multicenter randomized controlled trial from the Swedish Lumbar Spine Study Group. Spine (Phila Pa 1976). 2001 Dec 1;26(23):2521-32; discussion 2532-4. doi: 10.1097/00007632-200112010-00002.
PubMed 11725230Weinstein JN, Tosteson TD, Lurie JD, Tosteson AN, Blood E, Hanscom B, Herkowitz H, Cammisa F, Albert T, Boden SD, Hilibrand A, Goldberg H, Berven S, An H; SPORT Investigators. Surgical versus nonsurgical therapy for lumbar spinal stenosis. N Engl J Med. 2008 Feb 21;358(8):794-810. doi: 10.1056/NEJMoa0707136.
PubMed 18287602Kapural L, Yu C, Doust MW, Gliner BE, Vallejo R, Sitzman BT, Amirdelfan K, Morgan DM, Brown LL, Yearwood TL, Bundschu R, Burton AW, Yang T, Benyamin R, Burgher AH. Novel 10-kHz High-frequency Therapy (HF10 Therapy) Is Superior to Traditional Low-frequency Spinal Cord Stimulation for the Treatment of Chronic Back and Leg Pain: The SENZA-RCT Randomized Controlled Trial. Anesthesiology. 2015 Oct;123(4):851-60. doi: 10.1097/ALN.0000000000000774.
PubMed 26218762Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine (Phila Pa 1976). 2000 Nov 15;25(22):2940-52; discussion 2952. doi: 10.1097/00007632-200011150-00017.
PubMed 11074683Achttien RJ, Powell A, Zoulas K, Staal JB, Rushton A. Prognostic factors for outcome following lumbar spine fusion surgery: a systematic review and narrative synthesis. Eur Spine J. 2022 Mar;31(3):623-668. doi: 10.1007/s00586-021-07018-5. Epub 2021 Oct 27.
PubMed 34705106Krauss P, Motov S, Bonk MN, Prescher A, Scorzin J, Hajiabadi MM, Schulte DM, Sommer B, Seiz-Rosenhagen M, Ahmadi R, Maciaczyk J, Lehmberg J, Shiban E. sPinal coRd stimulatiOn coMpared with lumbar InStrumEntation for low back pain after previous lumbar decompression (PROMISE): a prospective multicentre RCT. BMJ Open. 2023 Apr 3;13(4):e067784. doi: 10.1136/bmjopen-2022-067784.
PubMed 37012023
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- sPinal coRd stimulatiOn coMpared With Lumbar InStrumEntation for Low Back Pain After Previous Lumbar Decompression (PROMISE): a Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05466110
- Acronym / sponsor ID
- PROMISE / 22-0221
- Conditions
- Failed Back Surgery Syndrome, SCS, Neuromodulation, Spinal Cord Stimulation, Spinal Fusion, Low Back Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- University Hospital AugsburgUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 20 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Low back pain affects people of all ages and has become the leading cause of living with disability worldwide. Patients, suffering from persistent pain after spinal surgery in the absence of any clear spinal pathology are defined of having a "failed back surgery syndrome (FBSS)" and treatment of FBSS remains a great controversy in the spinal community. Apart from conservative treatment, spinal fusion remains as therapeutic option. Furthermore, minimal invasive Neuromodulation techniques might be a promising alternative. Aim of this randomized interventional multi center study is to compare treatment success in FBSS patients with either spinal cord stimulation (SCS) or fusion surgery, 12 months after intervention according to the Oswestry Disability Index (ODI) and other scales and scores. Radiological and health economic outcome also will be analysed for thorough comparison of techniques. Additionally, the safety of the interventions needs to be compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal Cord Stimulation Device | Experimental | Device: Spinal Cord StimulationThe spinal cord stimulators WaveWriter AlphaTM (Boston Scientific) are designed to treat chronic back or leg pain by electrically stimulating the spinal cord. It is a well established worldwide licensed device. Percutaneous lead(-s) are implanted in the epidural space of the thoracic spine during the initial procedure. After discharge a trial phase is initiated and performed according to local preferences and standard of operations (SOPs). Patients are monitored for any complications and pain reduction. If a significant pain reduction (>50 % on the NRS scale for back pain) is achieved, the permanent implantable pulse generator (IPG) is implanted. Otherwise if the therapy remains non-beneficial throughout the trial phase, the leads will be explanted. Patients are allowed to crossover in the fusion group at any point of time. |
| Control - Lumbar Fusion surgery | Active comparator | Procedure: Spinal Fusion SurgeryThe control group needs to represent the standard of care of current practice. Gold standard is lumbar fusion surgery [Resnik 2005]. Surgical instrumentation will be performed according to local preferences and SOPs. Safety and efficacy of these fusion techniques have been repeatedly proven |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years
- Symptomatic degenerative disc disease with LBP as a predominant symptom for at least 6 months following pervious surgery for disc herniation
- ODI score at least 21
- Correctly signed informed consent form
Key exclusion criteria (3 listed)
- Spinal stenosis resulting in spinal claudication or neurological deficits
- Spinal Instability (> 3 mm Motion on dynamic Lumbar X-rays)
- Major psychiatric disorder
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 StimulationAlso: SCSEpidural application of electrical current to the spinal cord | Device | Spinal Cord Stimulation Device |
| Spinal Fusion Surgeryscrew-rod system based spinal instrumentation | Procedure or surgery | Control - Lumbar Fusion surgery |
Primary outcome
Oswestry disability index / ODI
Time frame: 12 months after intervention
A patient reported outcome measure to rate pain and disability
6 secondary outcomes
Adverse events
Time frame: 12 months after intervention
SF36
Time frame: 12 months after intervention
EuroQOL 5D
Time frame: 12 months after intervention
hospital length of stay
Time frame: through study completion, an average of 2 years
Crossover rates
Time frame: 12 months after intervention
Pain medication
Time frame: 12 months after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
- Background: PubMed 16028738Resnick DK, Choudhri TF, Dailey AT, Groff MW, Khoo L, Matz PG, Mummaneni P, Watters WC 3rd, Wang J, Walters BC, Hadley MN; American Association of Neurological Surgeons/Congress of Neurological Surgeons. Guidelines for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 10: fusion following decompression in patients with stenosis without spondylolisthesis. J Neurosurg Spine. 2005 Jun;2(6):686-91. doi: 10.3171/spi.2005.2.6.0686.
- Background: PubMed 12973134Brox JI, Sorensen R, Friis A, Nygaard O, Indahl A, Keller A, Ingebrigtsen T, Eriksen HR, Holm I, Koller AK, Riise R, Reikeras O. Randomized clinical trial of lumbar instrumented fusion and cognitive intervention and exercises in patients with chronic low back pain and disc degeneration. Spine (Phila Pa 1976). 2003 Sep 1;28(17):1913-21. doi: 10.1097/01.BRS.0000083234.62751.7A.
- Background: PubMed 11725230Fritzell P, Hagg O, Wessberg P, Nordwall A; Swedish Lumbar Spine Study Group. 2001 Volvo Award Winner in Clinical Studies: Lumbar fusion versus nonsurgical treatment for chronic low back pain: a multicenter randomized controlled trial from the Swedish Lumbar Spine Study Group. Spine (Phila Pa 1976). 2001 Dec 1;26(23):2521-32; discussion 2532-4. doi: 10.1097/00007632-200112010-00002.
- Background: PubMed 18287602Weinstein JN, Tosteson TD, Lurie JD, Tosteson AN, Blood E, Hanscom B, Herkowitz H, Cammisa F, Albert T, Boden SD, Hilibrand A, Goldberg H, Berven S, An H; SPORT Investigators. Surgical versus nonsurgical therapy for lumbar spinal stenosis. N Engl J Med. 2008 Feb 21;358(8):794-810. doi: 10.1056/NEJMoa0707136.
- Background: PubMed 26218762Kapural L, Yu C, Doust MW, Gliner BE, Vallejo R, Sitzman BT, Amirdelfan K, Morgan DM, Brown LL, Yearwood TL, Bundschu R, Burton AW, Yang T, Benyamin R, Burgher AH. Novel 10-kHz High-frequency Therapy (HF10 Therapy) Is Superior to Traditional Low-frequency Spinal Cord Stimulation for the Treatment of Chronic Back and Leg Pain: The SENZA-RCT Randomized Controlled Trial. Anesthesiology. 2015 Oct;123(4):851-60. doi: 10.1097/ALN.0000000000000774.
- Background: PubMed 11074683Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine (Phila Pa 1976). 2000 Nov 15;25(22):2940-52; discussion 2952. doi: 10.1097/00007632-200011150-00017.
- Background: PubMed 34705106Achttien RJ, Powell A, Zoulas K, Staal JB, Rushton A. Prognostic factors for outcome following lumbar spine fusion surgery: a systematic review and narrative synthesis. Eur Spine J. 2022 Mar;31(3):623-668. doi: 10.1007/s00586-021-07018-5. Epub 2021 Oct 27.
- Derived from this study: PubMed 37012023Krauss P, Motov S, Bonk MN, Prescher A, Scorzin J, Hajiabadi MM, Schulte DM, Sommer B, Seiz-Rosenhagen M, Ahmadi R, Maciaczyk J, Lehmberg J, Shiban E. sPinal coRd stimulatiOn coMpared with lumbar InStrumEntation for low back pain after previous lumbar decompression (PROMISE): a prospective multicentre RCT. BMJ Open. 2023 Apr 3;13(4):e067784. doi: 10.1136/bmjopen-2022-067784.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal Cord Stimulation and Spinal Fusion Surgery in people with Failed Back Surgery Syndrome and SCS, run by University Hospital Augsburg at 1 site in Germany.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ehab Shiban, MD (0049 / (0)821 / 400-2251, ehab.shiban@uk-augsburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oswestry disability index / ODI (time frame: 12 months after intervention). 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 NCT05466110, which also lists 8 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 14 Apr 2023.