Failed Back Surgery SyndromeMULTIWAVENCT03014583
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
A study testing Precision Spectra™ system in people with Failed Back Surgery Syndrome, run by Poitiers University Hospital at 1 site in France.
Trial 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. 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?
- Precision Spectra™ system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jan 2017to 21 Sep 2021
- 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 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.).
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- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
- Conditions
- Failed Back Surgery Syndrome
- Being tested
- Precision Spectra™ system
- 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.
Precision Spectra™ systemDevice
Neurostimulation procedures
| Study group | Role | What they receive |
|---|---|---|
| HF/TCS/BURST | Experimental | HF/TCS/BURST Receives: Device: Precision Spectra™ system |
| HF/BURST/TCS | Experimental | HF/BURST/TCS Receives: Device: Precision Spectra™ system |
| BURST/HF/TCS | Experimental | BURST/HF/TCS Receives: Device: Precision Spectra™ system |
| BURST/TCS/HF | Experimental | BURST/TCS/HF Receives: Device: Precision Spectra™ system |
| TCS/BURST/HF | Experimental | TCS/BURST/HF Receives: Device: Precision Spectra™ system |
| TCS/HF/BURST | Experimental | TCS/HF/BURST Receives: Device: Precision Spectra™ system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Pain VAS Visual Analogic Scale (VAS)
Global pain intensity from 0 to 10.
Measured: Month 3
Secondary outcomes (8)
Leg and back Pain Visual Analogic Scale (VAS)
Leg and back pain intensity from 0 to 10.
Measured: Inclusion, Implantation, Month 0, Month 1, Month 2, Month 3, Month 6, Month 9, Month 15
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.
Measured: Inclusion, Implantation, Month 0, Month 1, Month 2, Month 3, Month 6, Month 9, Month 15
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.
Measured: Inclusion, Implantation, Month 0, Month 1, Month 2, Month 3, Month 6, Month 9, Month 15
Paraesthesia perception Visual Analogic Scale (VAS)
Paraesthesia perception scale intensity from 0 to 10.
Measured: Implantation, Month 0, Month 1, Month 2, Month 3, Month 6, Month 9, Month 15
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
Measured: from Inclusion to Month 15 (End Of Study)
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.
Measured: Inclusion, Implantation, Month 0, Month 1, Month 2, Month 3, Month 6, Month 9, Month 15
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.
Measured: Implantation, Month 0, Month 1, Month 2, Month 3, Month 6, Month 9, Month 15
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."
Measured: Month 0, Month 1, Month 2, Month 3, Month 6, Month 9, Month 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2017 (estimated)
- Study start19 Jan 2017
- Primary completion21 Sep 2021
- Study completion21 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Failed Back Surgery SyndromeStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03014583
- Sponsor's protocol ID
- 2016-A01145-46
- Acronym
- MULTIWAVE
- Status last verified
- Nov 2021
- First submitted
- 13 Dec 2016
- Last updated
- 29 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32746899
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03014583
- Acronym / sponsor ID
- MULTIWAVE / 2016-A01145-46
- Conditions
- Failed Back Surgery Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 19 Jan 2017 (actual)
- Primary completion
- 21 Sep 2021 (actual)
- Study completion
- 21 Sep 2021 (actual)
- First posted
- 9 Jan 2017 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| HF/TCS/BURST | Experimental | Device: Precision Spectra™ systemHF/TCS/BURST |
| HF/BURST/TCS | Experimental | Device: Precision Spectra™ systemHF/BURST/TCS |
| BURST/HF/TCS | Experimental | Device: Precision Spectra™ systemBURST/HF/TCS |
| BURST/TCS/HF | Experimental | Device: Precision Spectra™ systemBURST/TCS/HF |
| TCS/BURST/HF | Experimental | Device: Precision Spectra™ systemTCS/BURST/HF |
| TCS/HF/BURST | Experimental | Device: Precision Spectra™ systemTCS/HF/BURST |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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).
Key exclusion criteria (11 listed)
- 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.
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 |
|---|---|---|
| Precision Spectra™ systemNeurostimulation procedures | Device | BURST/HF/TCS, BURST/TCS/HF, HF/BURST/TCS, HF/TCS/BURST, TCS/BURST/HF, TCS/HF/BURST |
Primary outcome
Global Pain VAS Visual Analogic Scale (VAS)
Time frame: Month 3
Global pain intensity from 0 to 10.
8 secondary outcomes
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
Oswestry Disability Index (ODI)
Time frame: 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
Paraesthesia perception Visual Analogic Scale (VAS)
Time frame: 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)
Hospital Anxiety and Depression Scale (HADS)
Time frame: 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
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
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 29 Nov 2021.
- Derived from this study: PubMed 32746899Billot 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Precision Spectra™ system 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 12 inclusion and 11 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 29 Nov 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?
Global Pain VAS Visual Analogic Scale (VAS) (time frame: Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03014583, which also lists 1 linked publication.
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 29 Nov 2021.