Failed Back Surgery SyndromeESTIMETNCT01628237
Effectiveness and Cost Management of Multicolumn Spinal Cord Stimulation in Neuropathic Pain Patients With Failed Back Surgery Syndrome
A study testing comparison of spinal cord stimulation in people with Failed Back Surgery Syndrome, run by Poitiers University Hospital at 1 site in France.
Trial summary
Failed back surgery syndrome (FBSS) constitutes a frequent pathology, generates a severe handicap for patients and represents a considerable expense for healthcare system. Neurostimulation has currently not been validated in the treatment of back pain because of technological limitations in implantable spinal cord… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Failed Back Surgery Syndrome
- What is being tested?
- comparison of spinal cord stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteFrance
- Study dates
- May 2012to Jan 2015
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged from 18 to 80 years
- Presence of FBSS ≥ 3 months after one or several spine surgery
- Presence of back and leg pain with documented neuropathic component (DN4)
- Having failed well conducted conservative treatment
- Meeting the criteria for a test of spinal cord stimulation as recommended by HAS (multidisciplinary consultation, psychological evaluation
- Presence of uni-or bilateral radicular pain with severe intensity, VAS score greater than or equal to 50/100 (daily VAS mean on 5 consecutive days).
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- Presence of associated back pain, as related to type "bar" or "tender points"
- Understanding and accepting the constraints of the study
- Covered by a French Health Insurance plan or benefiting of such as a third party in agreement with the French law (Huriet law n°88.1138 and modifications) on biomedical research
- Has given written consent to the study after receiving clear information.
- Absence of psychosis or evolutionary history of severe psychosis requiring hospitalization.
- Absence of progressive malignancy
Who cannot join
- Age < 18 and > 80 years
- Accessible because of back pain surgery 'mechanical' causal (discogenic back pain, spinal instability, spinal deformation)
- Presence of surgery, anesthetic and psychiatric contraindication for spinal cord stimulation system implantation
- Absence of informed consent signature
- Women of childbearing without effective contraception (hormonal / mechanical: oral, injectable, transdermal, implantable, intrauterine device or surgical: tubal ligation, hysterectomy, oophorectomy total) or breastfeeding.
- Subject not covered by a French Health Insurance plan or not benefiting of such as a third party
- Subject receiving enhanced protection: minors, pregnant women, nursing women, persons deprived of liberty by a judicial or administrative decision, adults under legal protection, and finally patients in emergency situations.
Trial locations and contacts
1 site in 1 country.
About this study
Failed back surgery syndrome (FBSS) constitutes a frequent pathology, generates a severe handicap for patients and represents a considerable expense for healthcare system. Neurostimulation has currently not been validated in the treatment of back pain because of technological limitations in implantable spinal cord stimulation (SCS). The lack of a validated technique for back pain relief has prompted the development of newer devices, including leads with increased number of contacts (up to 16) and various geometric arrangements, the objective of which is to cover a larger area while attempting to extend, steer, or focus the electric field of the stimulation within the spinal cord regions. This led companies to design a new generation of multicolumn surgical leads that allow the activation of longitudinal and transverse electric fields (multicolumn spinal cord stimulation, MSCS) in order to provide bilateral paresthesia coverage of back pain.
The objective of this study is to compare the analgesic efficacy of MSCS (using longitudinal and transverse electric stimulation) versus mono-column spinal cord stimulation (CSCS, using axial stimulation, actually represented by quadripolar or octopolar lead) on the treatment of lumbar pain.
Read more
A total of 115 patients will be randomized to either CSCS or MSCS. Patients, between 18 and 80 years old suffering from refractory neuropathic pain of radicular origin with associated back pain will be included. Patients will be divided into two groups. One group with MSCS during the 12 months after the new generation electrode implantation and one group with CSCS during 6 months and MSCS between 6 and 12 months after the new generation electrode implantation.
The following parameters will be evaluated during this study: overall pain VAS, leg pain VAS, back pain VAS, Oswestry disability index, Montgomery and Asberg Depression Rating scale, Brief Anxiety Scale and the Euro Quality of Life-5 Dimension Health questionnaire and costing in relation to surgery and patient management.
- Conditions
- Failed Back Surgery Syndrome
- Being tested
- comparison of spinal cord stimulation
- Medical subject headings
- Failed Back Surgery Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comparison of spinal cord stimulationDevice
Also called Specify(TM) 5-6-5 lead (Medtronic)
| Study group | Role | What they receive |
|---|---|---|
| Monocolumn spinal cord stimulation | Active comparator | Specify 5-6-5 Lead (only one column) Receives: Device: comparison of spinal cord stimulation |
| Multicolumn spinal cord stimulation | Experimental | Specify 5-6-5 Lead Receives: Device: comparison of spinal cord stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogic Scale Low Back pain
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2012 (estimated)
- Study startMay 2012
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Failed Back Surgery SyndromeStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01628237
- Sponsor's protocol ID
- 2011-A011695-36
- Acronym
- ESTIMET
- Status last verified
- Mar 2014
- First submitted
- 3 May 2012
- Last updated
- 16 Feb 2015
- Results posted
- No
Publications
Roulaud M, Durand-Zaleski I, Ingrand P, Serrie A, Diallo B, Peruzzi P, Hieu PD, Voirin J, Raoul S, Page P, Fontaine D, Lanteri-Minet M, Blond S, Buisset N, Cuny E, Cadenne M, Caire F, Ranoux D, Mertens P, Naous H, Simon E, Emery E, Gadan B, Regis J, Sol JC, Beraud G, Debiais F, Durand G, Guetarni Ging F, Prevost A, Brandet C, Monlezun O, Delmotte A, d'Houtaud S, Bataille B, Rigoard P. Multicolumn spinal cord stimulation for significant low back pain in failed back surgery syndrome: design of a national, multicentre, randomized, controlled health economics trial (ESTIMET Study). Neurochirurgie. 2015 Mar;61 Suppl 1:S109-16. doi: 10.1016/j.neuchi.2014.10.105. Epub 2014 Nov 20.
PubMed 25456442
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Cost Management of Multicolumn Spinal Cord Stimulation in Neuropathic Pain Patients With Failed Back Surgery Syndrome
- ClinicalTrials.gov ID
- NCT01628237
- Acronym / sponsor ID
- ESTIMET / 2011-A011695-36
- Conditions
- Failed Back Surgery Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 26 Jun 2012 (estimated)
- 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.
Failed back surgery syndrome (FBSS) constitutes a frequent pathology, generates a severe handicap for patients and represents a considerable expense for healthcare system. Neurostimulation has currently not been validated in the treatment of back pain because of technological limitations in implantable spinal cord stimulation (SCS). The lack of a validated technique for back pain relief has prompted the development of newer devices, including leads with increased number of contacts (up to 16) and various geometric arrangements, the objective of which is to cover a larger area while attempting to extend, steer, or focus the electric field of the stimulation within the spinal cord regions. This led companies to design a new generation of multicolumn surgical leads that allow the activation of longitudinal and transverse electric fields (multicolumn spinal cord stimulation, MSCS) in order to provide bilateral paresthesia coverage of back pain.
The objective of this study is to compare the analgesic efficacy of MSCS (using longitudinal and transverse electric stimulation) versus mono-column spinal cord stimulation (CSCS, using axial stimulation, actually represented by quadripolar or octopolar lead) on the treatment of lumbar pain.
A total of 115 patients will be randomized to either CSCS or MSCS. Patients, between 18 and 80 years old suffering from refractory neuropathic pain of radicular origin with associated back pain will be included. Patients will be divided into two groups. One group with MSCS during the 12 months after the new generation electrode implantation and one group with CSCS during 6 months and MSCS between 6 and 12 months after the new generation electrode implantation.
The following parameters will be evaluated during this study: overall pain VAS, leg pain VAS, back pain VAS, Oswestry disability index, Montgomery and Asberg Depression Rating scale, Brief Anxiety Scale and the Euro Quality of Life-5 Dimension Health questionnaire and costing in relation to surgery and patient management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monocolumn spinal cord stimulation | Active comparator | Device: comparison of spinal cord stimulationSpecify 5-6-5 Lead (only one column) |
| Multicolumn spinal cord stimulation | Experimental | Device: comparison of spinal cord stimulationSpecify 5-6-5 Lead |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Aged from 18 to 80 years
- Presence of FBSS ≥ 3 months after one or several spine surgery
- Presence of back and leg pain with documented neuropathic component (DN4)
- Having failed well conducted conservative treatment
- Meeting the criteria for a test of spinal cord stimulation as recommended by HAS (multidisciplinary consultation, psychological evaluation
Key exclusion criteria (7 listed)
- Age < 18 and > 80 years
- Accessible because of back pain surgery 'mechanical' causal (discogenic back pain, spinal instability, spinal deformation)
- Presence of surgery, anesthetic and psychiatric contraindication for spinal cord stimulation system implantation
- Absence of informed consent signature
- Women of childbearing without effective contraception (hormonal / mechanical: oral, injectable, transdermal, implantable, intrauterine device or surgical: tubal ligation, hysterectomy, oophorectomy total) or breastfeeding.
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 |
|---|---|---|
| comparison of spinal cord stimulationAlso: Specify(TM) 5-6-5 lead (Medtronic) | Device | Monocolumn spinal cord stimulation, Multicolumn spinal cord stimulation |
Primary outcome
Visual Analogic Scale Low Back pain
Time frame: Month 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2015.
- Derived from this study: PubMed 25456442Roulaud M, Durand-Zaleski I, Ingrand P, Serrie A, Diallo B, Peruzzi P, Hieu PD, Voirin J, Raoul S, Page P, Fontaine D, Lanteri-Minet M, Blond S, Buisset N, Cuny E, Cadenne M, Caire F, Ranoux D, Mertens P, Naous H, Simon E, Emery E, Gadan B, Regis J, Sol JC, Beraud G, Debiais F, Durand G, Guetarni Ging F, Prevost A, Brandet C, Monlezun O, Delmotte A, d'Houtaud S, Bataille B, Rigoard P. Multicolumn spinal cord stimulation for significant low back pain in failed back surgery syndrome: design of a national, multicentre, randomized, controlled health economics trial (ESTIMET Study). Neurochirurgie. 2015 Mar;61 Suppl 1:S109-16. doi: 10.1016/j.neuchi.2014.10.105. Epub 2014 Nov 20.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing comparison of spinal cord stimulation in people with Failed Back Surgery Syndrome, run by Poitiers University Hospital at 1 site in France.
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 12 inclusion and 7 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 16 Feb 2015. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Visual Analogic Scale Low Back pain (time frame: Month 6). 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 NCT01628237, which also lists 1 linked publication.
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 16 Feb 2015.