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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)

Primary Purpose

Failed Back Surgery Syndrome

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Precision Spectra™ system

About this trial

This is an interventional treatment trial for Failed Back Surgery Syndrome

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Poitiers University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Arm Label

HF/TCS/BURST

HF/BURST/TCS

BURST/HF/TCS

BURST/TCS/HF

TCS/BURST/HF

TCS/HF/BURST

Arm Description

HF/TCS/BURST

HF/BURST/TCS

BURST/HF/TCS

BURST/TCS/HF

TCS/BURST/HF

TCS/HF/BURST

Outcomes

Primary Outcome Measures

Global Pain VAS Visual Analogic Scale (VAS)

Global pain intensity from 0 to 10.

Secondary Outcome Measures

Leg and back Pain Visual Analogic Scale (VAS)

Leg and back pain intensity from 0 to 10.

Oswestry Disability Index (ODI)

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.

EuroQol 5-Dimension 5 items (EQ-5D-5L)

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.

Paraesthesia perception Visual Analogic Scale (VAS)

Paraesthesia perception scale intensity from 0 to 10.

Adverse Events and Serious Adverse Events Collection

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

Hospital Anxiety and Depression Scale (HADS)

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.

Lead Performance and Lead Selectivity

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.

Patient satisfaction via Patient Global Impression of Change (PGIC)

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."

Full Information

NCT ID

NCT03014583

First Posted

December 13, 2016

Last Updated

November 26, 2021

Sponsor

Poitiers University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03014583

Brief Title

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

Acronym

MULTIWAVE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

January 19, 2017 (Actual)

Primary Completion Date

September 21, 2021 (Actual)

Study Completion Date

September 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Poitiers University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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.

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

Crossover Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HF/TCS/BURST

Arm Type

Experimental

Arm Description

HF/TCS/BURST

Arm Title

HF/BURST/TCS

Arm Type

Experimental

Arm Description

HF/BURST/TCS

Arm Title

BURST/HF/TCS

Arm Type

Experimental

Arm Description

BURST/HF/TCS

Arm Title

BURST/TCS/HF

Arm Type

Experimental

Arm Description

BURST/TCS/HF

Arm Title

TCS/BURST/HF

Arm Type

Experimental

Arm Description

TCS/BURST/HF

Arm Title

TCS/HF/BURST

Arm Type

Experimental

Arm Description

TCS/HF/BURST

Intervention Type

Device

Intervention Name(s)

Precision Spectra™ system

Intervention Description

Neurostimulation procedures

Primary Outcome Measure Information:

Title

Global Pain VAS Visual Analogic Scale (VAS)

Description

Global pain intensity from 0 to 10.

Time Frame

Month 3

Secondary Outcome Measure Information:

Title

Leg and back Pain Visual Analogic Scale (VAS)

Description

Leg and back pain intensity from 0 to 10.

Time Frame

Inclusion, Implantation, Month 0, Month 1, Month 2, Month 3, Month 6, Month 9, Month 15

Title

Oswestry Disability Index (ODI)

Description

Time Frame

Inclusion, Implantation, Month 0, Month 1, Month 2, Month 3, Month 6, Month 9, Month 15

Title

EuroQol 5-Dimension 5 items (EQ-5D-5L)

Description

Time Frame

Inclusion, Implantation, Month 0, Month 1, Month 2, Month 3, Month 6, Month 9, Month 15

Title

Paraesthesia perception Visual Analogic Scale (VAS)

Description

Paraesthesia perception scale intensity from 0 to 10.

Time Frame

Implantation, Month 0, Month 1, Month 2, Month 3, Month 6, Month 9, Month 15

Title

Adverse Events and Serious Adverse Events Collection

Description

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

Time Frame

from Inclusion to Month 15 (End Of Study)

Title

Hospital Anxiety and Depression Scale (HADS)

Description

Time Frame

Inclusion, Implantation, Month 0, Month 1, Month 2, Month 3, Month 6, Month 9, Month 15

Title

Lead Performance and Lead Selectivity

Description

Time Frame

Implantation, Month 0, Month 1, Month 2, Month 3, Month 6, Month 9, Month 15

Title

Patient satisfaction via Patient Global Impression of Change (PGIC)

Description

Time Frame

Month 0, Month 1, Month 2, Month 3, Month 6, Month 9, Month 15

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Facility Information:

Facility Name

Poitiers University Hospital

City

Poitiers

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

32746899

Citation

Billot M, Naiditch N, Brandet C, Lorgeoux B, Baron S, Ounajim A, Roulaud M, Roy-Moreau A, de Montgazon G, Charrier E, Misbert L, Maillard B, Vendeuvre T, Rigoard P. Comparison of conventional, burst and high-frequency spinal cord stimulation on pain relief in refractory failed back surgery syndrome patients: study protocol for a prospective randomized double-blinded cross-over trial (MULTIWAVE study). Trials. 2020 Aug 3;21(1):696. doi: 10.1186/s13063-020-04587-6.

Results Reference

derived

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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

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