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)

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 Overview

• Status: Completed
• Conditions: Failed Back Surgery Syndrome
• Intervention / Treatment: Device: Subcutaneous peripheral nerve stimulation; Other: SCS Only

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Poitiers, France, 86021
    • Poitiers University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SCS + PNS; Mutlticolumn SCS lead + Monocolumn SCS lead	Device: Subcutaneous peripheral nerve stimulation
Active Comparator: SCS; Mutlticolumn SCS lead	Other: SCS Only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Relative change of low back pain surface (expressed as a percentage, %)	3 month follow-up

Collaborators and Investigators

• Sponsor: Poitiers University Hospital
• Investigators: Principal Investigator: Philippe RIGOARD, MD, PhD, Poitiers University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2013
• Primary Completion (Actual): October 14, 2018
• Study Completion (Actual): October 14, 2018

Study Registration Dates

• First Submitted: April 4, 2014
• First Submitted That Met QC Criteria: April 8, 2014
• First Posted (Estimate): April 10, 2014

Study Record Updates

• Last Update Posted (Actual): October 18, 2021
• Last Update Submitted That Met QC Criteria: October 8, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Disease; Back Pain; Syndrome; Failed Back Surgery Syndrome
• Other Study ID Numbers: CUMPNS