Back to resultsSubcutaneous 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)
Primary Purpose
Failed Back Surgery Syndrome
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Subcutaneous peripheral nerve stimulation
SCS Only
Sponsored by
About this trial
This is an interventional treatment trial for Failed Back Surgery Syndrome
Eligibility Criteria
Inclusion Criteria:
- 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.).
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Poitiers University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
SCS + PNS
SCS
Arm Description
Mutlticolumn SCS lead + Monocolumn SCS lead
Mutlticolumn SCS lead
Outcomes
Primary Outcome Measures
Relative change of low back pain surface (expressed as a percentage, %)
Secondary Outcome Measures
Full Information
NCT ID
NCT02110888
First Posted
April 4, 2014
Last Updated
October 8, 2021
Sponsor
Poitiers University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02110888
Brief 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)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
February 2013 (Actual)
Primary Completion Date
October 14, 2018 (Actual)
Study Completion Date
October 14, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital
4. Oversight
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Failed Back Surgery Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SCS + PNS
Arm Type
Experimental
Arm Description
Mutlticolumn SCS lead + Monocolumn SCS lead
Arm Title
SCS
Arm Type
Active Comparator
Arm Description
Mutlticolumn SCS lead
Intervention Type
Device
Intervention Name(s)
Subcutaneous peripheral nerve stimulation
Intervention Type
Other
Intervention Name(s)
SCS Only
Primary Outcome Measure Information:
Title
Relative change of low back pain surface (expressed as a percentage, %)
Time Frame
3 month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.).
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe RIGOARD, MD, PhD
Organizational Affiliation
Poitiers University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Poitiers University Hospital
City
Poitiers
ZIP/Postal Code
86021
Country
France
12. IPD Sharing Statement
Learn more about this trial
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)
We'll reach out to this number within 24 hrs