Failed Back Surgery SyndromeNCT02110888
Subcutaneous Peripheral Nerve Stimulation (PNS) as "Hybrid Stimulation" After Failure of Spinal Cord Stimulation (SCS) to Control the Back Pain Component in Failed Back Surgery Syndrome (FBSS) Patients.(CUMPNS Study)
A study testing Subcutaneous peripheral nerve stimulation and SCS Only in people with Failed Back Surgery Syndrome, run by Poitiers University Hospital at 1 site in France.
Trial summary
Despite globally favourable outcomes of Spinal Cord Stimulation (SCS), a significant proportion of Failed Back Surgery Syndrome (FBSS) patients do not obtain adequate coverage of low back pain. 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?
- Subcutaneous peripheral nerve stimulation and SCS Only
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2013to 14 Oct 2018
- 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
- Age ≥ 18 years and ≤ 80 years.
- History of FBSS after one or more surgical procedures on the spine, treated with SCS,
- Failure of well conducted conservative treatment (drug or non-drug).
- Patients implanted with a single-column or multicolumn SCS lead providing significant relief of the radicular pain component.
- Persistent failure on the low back pain component despite the efficacy of SCS on the radicular pain component.
- Patients with documented residual neuropathic low back pain (DN4, sensorimotor studies, clinical examination, pain characteristics, etc.).
Show all 13Show fewer
- Patients with significant residual low back pain with mean intensity on Visual Analogue Scale (VAS) ≥ 40 mm) despite Conventional Medical Management (CMM) and SCS (mean measure calculated on daily VAS scores on 5 consecutive days).
- Positive response to Transcutaneous Electrical Nerve Stimulation (TENS) trial on the back pain component.
- Patients understanding and accepting the study constraints.
- Patients covered by French national health insurance.
- Patients have signed the Informed Consent Form after being provided with clear and honest information about the study.
- Absence of active psychosis or serious psychotic history requiring hospitalisation.
- Absence of active cancer.
Who cannot join
- Age < 18 years and > 80 years.
- Back pain amenable to further aetiological biomechanical surgery (discogenic pain, spinal instability, spinal deformity, etc.).
- Surgical, psychiatric or anaesthetic contraindication to PNS lead implantation.
- Negative response to TENS trial.
- Absence of signature of the informed consent form.
- Patients not covered by French national health insurance.
- Subjects requiring closer protection, i.e. minors, pregnant women, nursing mothers, subjects deprived of their freedom by a court or administrative decision, subjects admitted to a health or social welfare establishment, major subjects under legal protection, and finally patients member of a high-risk population.
- Women of childbearing age not using effective contraception.
Trial locations and contacts
1 site in 1 country.
About this study
Despite globally favourable outcomes of Spinal Cord Stimulation (SCS), a significant proportion of Failed Back Surgery Syndrome (FBSS) patients do not obtain adequate coverage of low back pain. Peripheral Nerve Stimulation (PNS) has obtained the European Conformity mark for the treatment of chronic refractory neuropathic pain and is now commonly used in some countries to target back pain. However, the potential value of combining SCS and PNS as "hybrid stimulation" remains poorly described with only isolated case reports or limited experience in various indications.
The "CUMPNS" comparative randomized study is designed to demonstrate the potential analgesic efficacy of PNS in addition to previously implanted SCS, to treat the residual low back pain component pain in refractory FBSS patients.
- Conditions
- Failed Back Surgery Syndrome
- Being tested
- Subcutaneous peripheral nerve stimulation, SCS Only
- 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.
Subcutaneous peripheral nerve stimulationDevice
SCS OnlyOther
| Study group | Role | What they receive |
|---|---|---|
| SCS + PNS | Experimental | Mutlticolumn SCS lead + Monocolumn SCS lead Receives: Device: Subcutaneous peripheral nerve stimulation |
| SCS | Active comparator | Mutlticolumn SCS lead Receives: Other: SCS Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative change of low back pain surface (expressed as a percentage, %)
Measured: 3 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2014 (estimated)
- Study startFeb 2013
- Primary completion14 Oct 2018
- Study completion14 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe RIGOARD, MD, PhD, Principal investigator, Poitiers University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02110888
- Sponsor's protocol ID
- CUMPNS
- Status last verified
- Sep 2021
- First submitted
- 4 Apr 2014
- Last updated
- 18 Oct 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subcutaneous Peripheral Nerve Stimulation (PNS) as "Hybrid Stimulation" After Failure of Spinal Cord Stimulation (SCS) to Control the Back Pain Component in Failed Back Surgery Syndrome (FBSS) Patients.(CUMPNS Study)
- ClinicalTrials.gov ID
- NCT02110888
- Acronym / sponsor ID
- CUMPNS
- Conditions
- Failed Back Surgery Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- Feb 2013 (actual)
- Primary completion
- 14 Oct 2018 (actual)
- Study completion
- 14 Oct 2018 (actual)
- First posted
- 10 Apr 2014 (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.
Despite globally favourable outcomes of Spinal Cord Stimulation (SCS), a significant proportion of Failed Back Surgery Syndrome (FBSS) patients do not obtain adequate coverage of low back pain. Peripheral Nerve Stimulation (PNS) has obtained the European Conformity mark for the treatment of chronic refractory neuropathic pain and is now commonly used in some countries to target back pain. However, the potential value of combining SCS and PNS as "hybrid stimulation" remains poorly described with only isolated case reports or limited experience in various indications.
The "CUMPNS" comparative randomized study is designed to demonstrate the potential analgesic efficacy of PNS in addition to previously implanted SCS, to treat the residual low back pain component pain in refractory FBSS patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCS + PNS | Experimental | Device: Subcutaneous peripheral nerve stimulationMutlticolumn SCS lead + Monocolumn SCS lead |
| SCS | Active comparator | Other: SCS OnlyMutlticolumn SCS lead |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age ≥ 18 years and ≤ 80 years.
- History of FBSS after one or more surgical procedures on the spine, treated with SCS,
- Failure of well conducted conservative treatment (drug or non-drug).
- Patients implanted with a single-column or multicolumn SCS lead providing significant relief of the radicular pain component.
- Persistent failure on the low back pain component despite the efficacy of SCS on the radicular pain component.
Key exclusion criteria (8 listed)
- Age < 18 years and > 80 years.
- Back pain amenable to further aetiological biomechanical surgery (discogenic pain, spinal instability, spinal deformity, etc.).
- Surgical, psychiatric or anaesthetic contraindication to PNS lead implantation.
- Negative response to TENS trial.
- Absence of signature of the informed consent form.
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 |
|---|---|---|
| Subcutaneous peripheral nerve stimulation | Device | SCS + PNS |
| SCS Only | Other | SCS |
Primary outcome
Relative change of low back pain surface (expressed as a percentage, %)
Time frame: 3 month follow-up
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 18 Oct 2021.
Related trials for Failed Back Surgery Syndrome
RecruitingObservational study
Open and Closed Loop DTM SCS in Patients With PSPS Type 2: ENDLESS Study
Persistent Spinal Pain Syndrome Type 2, Failed Back Surgery Syndrome
RecruitingPhase 4
Success Rates and Safety of Steroid Injections in Managing Spinal and Sacro-Iliac Pain (CORTisone Injection Spine Study)
Back Pain Lower Back, Neck Pain
Not yet recruitingObservational study
SPINE-RISK VE: Multimodal Predictive Model for Failed Back Surgery Syndrome in Venezuelan Surgical Patients
Persistent Spinal Pain Syndrome Type 2 (PSPS-T) Lower Spine, Chronic Low Back Pain
Active, not recruiting
Restoring Segmental Lumbar Lordosis After Failed Previous Fusion at the Same Level
Failed Back Surgery Syndrome, Degeneration Lumbar Spine
Recruiting
Improvement of Gait by Spinal Stimulation in Patients With Postoperative Chronic Lumbosciatalgia: Pilot Study (GaitStim)
Failed Back Surgery Syndrome
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 principal investigator
Poitiers University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subcutaneous peripheral nerve stimulation and SCS Only 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 13 inclusion and 8 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 18 Oct 2021. 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?
Relative change of low back pain surface (expressed as a percentage, %) (time frame: 3 month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Oct 2021.