Study Comparing Conventional, Burst and High Frequency (HF) Spinal Cord Stimulation (SCS) in Refractory Failed Back Surgery Syndrome (FBSS) Patients After a 32-contact Surgical Lead Implantation (MULTIWAVE)

November 26, 2021 updated by: Poitiers University Hospital

Prospective, Randomized Study Comparing Conventional, Burst And High Frequency (HF) Spinal Cord Stimulation (SCS) in Refractory Failed Back Surgery Syndrome (FBSS) Patients After a 32-contact Surgical Lead Implantation

Chronic Back and/or Leg Pain (CBLP) after spinal surgical procedures, a condition commonly labelled Failed Back Surgery Syndrome (FBSS), affects between 15% and 40% of patients after a spine surgery. Treatment of this chronic condition by further operation or medical management has a heavy financial impact on health care systems.

Many studies have demonstrated the efficacy and economic value of Spinal Cord Stimulation (SCS) for chronic neuropathic pain, and randomized controlled trials (RCTs) have shown SCS to be a clinically effective adjunct to medical management. SCS has the advantages of being reversible and less invasive than surgery and may cause fewer issues over time than long-term pharmacological treatments.

Despite variable levels of success in the literature, approximately 30-55% of the patients treated with traditional SCS for neuropathic pain disorders will not receive adequate long term pain relief. Therefore, technical SCS system refinements, as well as new techniques have emerged.

Two new stimulation waveforms based on traditional SCS technology have appeared to further optimize the outcome for specific painful conditions;

  • Burst stimulation mode: which generates constant-current stimuli with 5 spikes at 500 Hz per burst and pulse width and interspike intervals of 1 ms.
  • High-frequency stimulation (from 1 to 10 kHz) mode.

Several studies have demonstrated the potential interest of these 2 new waveforms to treat FBSS patients compared to traditional SCS.

The Precision Spectra™ system allows MultiWave Technology by offering a broad spectrum of waveform options (from Tonic Conventional Stimulation (TCS), BURST stimulation to High Frequency stimulation (HF)).

To date, literature data comparing these 3 stimulation patterns is lacking but it is suggested the pain relief in some of non-responsive patients can be "recaptured" by increasing the SCS frequency to 500 Hz by BURST stimulation or beyond by HF stimulation. It seems important to conduct RCT in crossover, thanks to the new Precision SCS Stimulator, to compare the effects of these 3 different SCS modalities in FBSS patients and to determine which concept is the most effective in terms of pain reduction and energy consumption.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Poitiers, France
        • Poitiers University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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 or ≤ 80 years.
  • Subject has FBSS and does not require further surgery. For the purposes of this study, FBSS is defined as persistent or recurrent low back and leg pain of at least 6 months duration following at least one decompression and/or fusion procedure.
  • Subject has persistent low back and leg pain despite other treatment modalities (pharmacological, surgical, physical, or psychological therapies) that have been tried and did not prove satisfactory or are unsuitable or contraindicated for the subject.
  • Average global pain is ≥ 50 mm as assessed by the baseline VAS.
  • With significant back, with mean intensity on a back pain VAS ≥ 50 mm (mean daily VAS score calculated on 5 consecutive days).
  • Meeting the criteria for spinal cord stimulation test according to HAS guidelines (multidisciplinary consultation, psychological assessment, etc.).
  • Subject is a candidate for SCS.
  • Absence of active psychosis or history of serious psychotic illness requiring hospitalisation.
  • Understands and accepts the constraints of the study.
  • Free subject, not under temporary or permanent guardianship and not subject to subordination.
  • Patients covered by French national health insurance.
  • Patients who have given their written consent to the study after having received clear information.

Exclusion Criteria:

  • Age < 18 years or > 80 years
  • Subject is or has been treated with SCS, subcutaneous or peripheral nerve stimulation, an intrathecal drug delivery system, requires back surgery at the location related to his/her original back pain complaint or experimental therapies.
  • Cause of low back pain accessible to etiological "mechanical" surgical treatment (discogenic low back pain, vertebral instability, spinal deformity, etc.).
  • Subject had most recent back surgery less than 6 months ago.
  • Presenting a surgical, anaesthetic or psychiatric contraindication to implantation of a spinal cord stimulation system.
  • Based on the opinion of the principal or sub-investigator, the subject is unable to operate the SCS equipment.
  • Subject has a life expectancy of less than 24 months beyond study enrolment.
  • 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 in an emergency setting.
  • Pregnant women, nursing mothers, women of childbearing potential not using effective contraception (hormonal/barrier: oral, parenteral, percutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total ovariectomy).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: HF/TCS/BURST
Device: Precision Spectra™ system
Neurostimulation procedures
EXPERIMENTAL: HF/BURST/TCS
Device: Precision Spectra™ system
Neurostimulation procedures
EXPERIMENTAL: BURST/HF/TCS
Device: Precision Spectra™ system
Neurostimulation procedures
EXPERIMENTAL: BURST/TCS/HF
Device: Precision Spectra™ system
Neurostimulation procedures
EXPERIMENTAL: TCS/BURST/HF
Device: Precision Spectra™ system
Neurostimulation procedures
EXPERIMENTAL: TCS/HF/BURST
Device: Precision Spectra™ system
Neurostimulation procedures

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Global Pain VAS Visual Analogic Scale (VAS)
Time Frame: Month 3
Global pain intensity from 0 to 10.
Month 3

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Leg and back Pain Visual Analogic Scale (VAS)
Time Frame: Inclusion, Implantation, Month 0, Month 1, Month 2, Month 3, Month 6, Month 9, Month 15
Leg and back pain intensity from 0 to 10.
Inclusion, Implantation, Month 0, Month 1, Month 2, Month 3, Month 6, Month 9, Month 15
Oswestry Disability Index (ODI)
Time Frame: Inclusion, Implantation, Month 0, Month 1, Month 2, Month 3, Month 6, Month 9, Month 15
Self-administered questionnaire with 10 items. These items comprise assessments concerning pain intensity, degree of disability for personal care, lifting, walking, sitting, standing, sleeping, sex life, social life and travelling. The score is between 0 and 100% for which 0% is the best score.
Inclusion, Implantation, Month 0, Month 1, Month 2, Month 3, Month 6, Month 9, Month 15
EuroQol 5-Dimension 5 items (EQ-5D-5L)
Time Frame: Inclusion, Implantation, Month 0, Month 1, Month 2, Month 3, Month 6, Month 9, Month 15
EQ-5D is a generic quality of life scale that is not specific for low back pain. The scale comprises 5 questions assessing mobility, self-care, usual activities, pain/discomfort and anxiety/depression. A global index with a maximum score of 1 is calculated from the responses to these 5 dimensions by means of nomograms. The maximum score of 1 indicates the best possible quality of life.
Inclusion, Implantation, Month 0, Month 1, Month 2, Month 3, Month 6, Month 9, Month 15
Paraesthesia perception Visual Analogic Scale (VAS)
Time Frame: Implantation, Month 0, Month 1, Month 2, Month 3, Month 6, Month 9, Month 15
Paraesthesia perception scale intensity from 0 to 10.
Implantation, Month 0, Month 1, Month 2, Month 3, Month 6, Month 9, Month 15
Adverse Events and Serious Adverse Events Collection
Time Frame: from Inclusion to Month 15 (End Of Study)
Any harmful event occurring in a person participating in a clinical trial, which is not necessarily related to the clinical trial or to the medical device used in this clinical trial
from Inclusion to Month 15 (End Of Study)
Hospital Anxiety and Depression Scale (HADS)
Time Frame: Inclusion, Implantation, Month 0, Month 1, Month 2, Month 3, Month 6, Month 9, Month 15
The HADS scale investigates symptoms of anxiety and depression and their severity. Each answer corresponds to a number between 0 and 3. Adding these numbers together gives a total score per column (anxiety and depression). If the score of a column is greater than or equal to 11, this means that you are suffering from anxiety or depression.
Inclusion, Implantation, Month 0, Month 1, Month 2, Month 3, Month 6, Month 9, Month 15
Lead Performance and Lead Selectivity
Time Frame: Implantation, Month 0, Month 1, Month 2, Month 3, Month 6, Month 9, Month 15

Lead performance: Overlapped surface ratios between paraesthesia coverage and painful area.

Lead specificity: Overlapped surface ratios between paraesthesia coverage and non-painful area, unwanted to be covered.
Implantation, Month 0, Month 1, Month 2, Month 3, Month 6, Month 9, Month 15
Patient satisfaction via Patient Global Impression of Change (PGIC)
Time Frame: Month 0, Month 1, Month 2, Month 3, Month 6, Month 9, Month 15
The self-report measure Patient Global Impression of Change (PGIC) reflects a patient's belief about the efficacy of treatment. Although widely used in chronic pain clinical trials, PGIC's validity has not been formally assessed. PGIC is a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse."
Month 0, Month 1, Month 2, Month 3, Month 6, Month 9, Month 15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Poitiers University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 19, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 21, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 21, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 13, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2017

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 9, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 29, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2016-A01145-46

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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