Failed Back Surgery SyndromeNCT03201705
A Novel Approach in Spinal Cord Stimulation: a Combination of Burst and Tonic Waveforms.
A study testing Burst + Tonic in people with Failed Back Surgery Syndrome, run by Massimo Innamorato.
Trial summary
Spinal Cord Stimulation (SCS) has been a well-established treatment for chronic neuropathic pain in Failed Back Surgery Syndrome with associated legs and/or low back pain. The waves used in Spinal Cord Stimulation are mainly Tonic or Burst. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Failed Back Surgery Syndrome
- What is being tested?
- Burst + Tonic
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2017to 31 Dec 2018
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic, persistent, refractory, low back pain as a result of spinal surgery
- Failed conservative treatments for chronic pain including but not limited to pharmacological therapy, physical therapy and minimally interventional pain procedures for chronic pain
- Pain radiating in the leg, following segments L4 and/or L5 and/or S1 for at least 6 months
- Minimum baseline pain intensity as assessed by VAS of ≥ 50mm on 100mm scale in the primary pain area
- Subject is able and willing to provide informed consent
- Subject is able and willing to comply with the protocol and follow-up schedule
Who cannot join
- Back pain component of more than 20% or VAS > 40mm on 100mm scale
- Bilateral limb pain
- Subjects with a previous SCS implantation
- Changes in pain medication in the 2 months preceding the trial period
- Expected inability of subjects to correctly operate the neurostimulation system
- Presence of any other clinically significant or disabling chronic pain condition (eg. hip arthrosis, rheumatoid arthritis, fibromyalgia, etc.)
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- History of coagulation disorders, lupus erythematosus, diabetes mellitus
- Symptoms or proof of any malignant disease
- Current use of medicines affecting coagulation which cannot be temporarily stopped
- Evidence of an active disruptive psychiatric disorder or other known condition significant enough to impact the perception of pain, compliance to intervention and/or ability to evaluate treatment outcome as determined by the investigator
- Life expectancy of less than 1 year
- Existing or planned pregnancy in the trial period
Trial locations and contacts
No sites are listed yet.
About this study
Spinal Cord Stimulation (SCS) has been a well-established treatment for chronic neuropathic pain in Failed Back Surgery Syndrome with associated legs and/or low back pain. The waves used in Spinal Cord Stimulation are mainly Tonic or Burst. Both Tonic and Burst stimulation offer neuropathic pain suppression, with slightly superiority of the Burst wave for the FBSS. The aim of our study is to evaluate the efficacy of a new stimulation paradigm with the combination of the two wave forms.
Read the detailed description
Spinal Cord Stimulation (SCS) has been a well-established treatment for chronic neuropathic pain for decades. One of the most general indication for SCS is Failed Back Surgery Syndrome with associated legs and/or low back pain.
Conventional low frequency neurostimulation is applied with a tonic wave shape (pulse width is usually 300 to 500 μsec, amplitude 2 to 5 mA, and frequency 40 to 50 Hz); this kind of stimulation produces a perceptible paraesthesias in the area of stimulation "covering" the region of pain. Further development in waves of stimulation during the recent years led to new paradigms of sub-perception stimulation like "Burst" stimulation that has characteristics of a cluster of waves with higher frequency.
The efficacy of these two wave forms has been demonstrated by different authors. Both Tonic and Burst stimulation offer neuropathic pain suppression, with slightly superiority of the Burst wave for the FBSS.
Recent advances in technology of the implantable devices for spinal cord stimulation led to the possibility to combine the two stimulation waves described allowing the design of a possible new paradigm of stimulation. The Tonic and Burst wave can be combined to stimulate the same pain area using the same configuration otherwise they can be programmed to stimulate two different pain areas with two different configurations. Both burst and tonic waveforms paradigms can be customized according to patients' need. The characteristics of this combined stimulation wave in terms of efficacy, non inferiority, energy consumption, and patient satisfaction are unknown.
The primary objective of this trial is to compare pain suppressive effect of Low Frequency "Tonic Wave" versus Low Frequency Combined "Burst and Tonic Wave" for Spinal Cord Stimulation in subjects with refractory neuropathic leg and low back pain as result of FBSS.
Patients fulfilling the inclusion criteria will be enrolled in the study and receive electrocatheter implant. Then, they will be observed for a two-weeks trial period in which the efficacy of the stimulation and the compliance of the patient is evaluated. During this trial a Tonic wave stimulation is administered by the external generator. After this trial, the definitive generator will be implanted. Two weeks of Tonic stimulation will follow the surgery to avoid any interference of the pain measurement with the surgical pain. After this two weeks period, the stimulation will be switched into the combined waveform for 15 days. At the end of the study period, the final waveform setting of the SCS will be in accord with the patient's stimulation preference.
- Conditions
- Failed Back Surgery Syndrome
- Being tested
- Burst + Tonic
- Keywords
- Failed Back Surgery Syndrome, Spinal Cord Stimulation, Pain Management, Implantable Neurostimulator
- Medical subject headings
- Failed Back Surgery Syndrome, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Burst + TonicDevice
Patients fulfilling the inclusion criteria will be enrolled in the study and receive electrocatheter implant (Precision Spectra system, Boston Scientific). Then, they will be observed for a two-weeks trial period in which the efficacy of the stimulation and the compliance of the patient is evaluated. During this trial a Tonic wave stimulation is administered by the external generator. After the trial, the definitive generator will be implanted. Tonic stimulation will be selected as wave form for four weeks. After this period, the stimulation will be switched into the combined waveform for 30 days. At the end of the study period, the final waveform setting of the SCS will be in accord with the patient's stimulation preference.
| Study group | Role | What they receive |
|---|---|---|
| Refractory neuropathic leg and low back pain | Experimental | Patients with refractory neuropathic leg and low back pain as result of FBSS will be enrolled in the study and receive electrocatheter implant. Then, they will be observed for a two-weeks trial period in which the efficacy of the stimulation and the compliance of the patient is evaluated. During this trial a Tonic wave stimulation is administered by the external generator. After the trial, the definitive generator will be implanted. Tonic stimulation will be selected as wave form for four weeks. After this period, the stimulation will be switched into the combined waveform for 30 days. At the end of the study period, the final waveform setting of the SCS will be in accord with the patient's stimulation preference. Receives: Device: Burst + Tonic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Suppression
Pain suppression by "Tonic" and "Burst+Tonic" waves Spinal Cord Stimulation, in relation at measure previous of implant, expressed with Numerical Rate Scale (NRS)
Measured: Baseline (pre intervention), 15 days and 30 days of Tonic Stimulation, 15 days and 30 days of Combined Stimulation
Secondary outcomes (10)
Change in quality of Life
Oswestry Disability Index
Measured: Baseline (pre intervention), 15 days and 30 days of Tonic Stimulation, 15 days and 30 days of Combined Stimulation
Change in energy use of the battery
Energy use index (0-10): Software calculated index indicating energy consumption of the device in relation with stimulation parameters
Measured: 15 days and 30 days of Tonic Stimulation, 15 days and 30 days of Combined Stimulation
Change in halving the pain
Percentage of subjects with 50% reduction in pain
Measured: 15 days and 30 days of Tonic Stimulation, 15 days and 30 days of Combined Stimulation
Change in use of rescue medication
Number of times in which the patient required rescue medication in a period
Measured: Baseline (pre intervention), 15 days and 30 days of Tonic Stimulation, 15 days and 30 days of Combined Stimulation
Change in number of stimulation adjustments
Number of amplitude adjustments in stimulation period
Measured: 15 days and 30 days of Tonic Stimulation, 15 days and 30 days of Combined Stimulation
Change in discomfort due to stimulation
Question: are the paresthesia in the limbs acceptable? Yes/No
Measured: 15 days and 30 days of Tonic Stimulation, 15 days and 30 days of Combined Stimulation
Change in disability
Oswestry Disability Index
Measured: Baseline (pre intervention), 15 days and 30 days of Tonic Stimulation, 15 days and 30 days of Combined Stimulation
Change in subject's satisfaction
Oswestry Disability Index
Measured: Baseline (pre intervention), 15 days and 30 days of Tonic Stimulation, 15 days and 30 days of Combined Stimulation
Change in social life
Oswestry Disability Index
Measured: Baseline (pre intervention), 15 days and 30 days of Tonic Stimulation, 15 days and 30 days of Combined Stimulation
Change in sleep pattern
Oswestry Disability Index
Measured: Baseline (pre intervention), 15 days and 30 days of Tonic Stimulation, 15 days and 30 days of Combined Stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study start1 Dec 2017 (estimated)
- Primary completion30 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massimo Innamorato
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Massimo Innamorato, Ospedale Santa Maria delle Croci
- Investigators
- Massimo Innamorato, MD, Study director, Ospedale Santa Maria delle Croci
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03201705
- Sponsor's protocol ID
- TONIC+BURST
- Status last verified
- Oct 2017
- First submitted
- 16 Jun 2017
- Last updated
- 3 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Approach in Spinal Cord Stimulation: a Combination of Burst and Tonic Waveforms.
- ClinicalTrials.gov ID
- NCT03201705
- Acronym / sponsor ID
- TONIC+BURST
- Conditions
- Failed Back Surgery Syndrome
- Keywords
- Failed Back Surgery Syndrome, Spinal Cord Stimulation, Pain Management, Implantable Neurostimulator
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Massimo InnamoratoUniversity, hospital or other
- Study start
- 1 Dec 2017 (estimated)
- Primary completion
- 30 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 28 Jun 2017 (actual)
- 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.
Spinal Cord Stimulation (SCS) has been a well-established treatment for chronic neuropathic pain in Failed Back Surgery Syndrome with associated legs and/or low back pain. The waves used in Spinal Cord Stimulation are mainly Tonic or Burst. Both Tonic and Burst stimulation offer neuropathic pain suppression, with slightly superiority of the Burst wave for the FBSS. The aim of our study is to evaluate the efficacy of a new stimulation paradigm with the combination of the two wave forms.
Detailed description
Spinal Cord Stimulation (SCS) has been a well-established treatment for chronic neuropathic pain for decades. One of the most general indication for SCS is Failed Back Surgery Syndrome with associated legs and/or low back pain.
Conventional low frequency neurostimulation is applied with a tonic wave shape (pulse width is usually 300 to 500 μsec, amplitude 2 to 5 mA, and frequency 40 to 50 Hz); this kind of stimulation produces a perceptible paraesthesias in the area of stimulation "covering" the region of pain. Further development in waves of stimulation during the recent years led to new paradigms of sub-perception stimulation like "Burst" stimulation that has characteristics of a cluster of waves with higher frequency.
The efficacy of these two wave forms has been demonstrated by different authors. Both Tonic and Burst stimulation offer neuropathic pain suppression, with slightly superiority of the Burst wave for the FBSS.
Recent advances in technology of the implantable devices for spinal cord stimulation led to the possibility to combine the two stimulation waves described allowing the design of a possible new paradigm of stimulation. The Tonic and Burst wave can be combined to stimulate the same pain area using the same configuration otherwise they can be programmed to stimulate two different pain areas with two different configurations. Both burst and tonic waveforms paradigms can be customized according to patients' need. The characteristics of this combined stimulation wave in terms of efficacy, non inferiority, energy consumption, and patient satisfaction are unknown.
The primary objective of this trial is to compare pain suppressive effect of Low Frequency "Tonic Wave" versus Low Frequency Combined "Burst and Tonic Wave" for Spinal Cord Stimulation in subjects with refractory neuropathic leg and low back pain as result of FBSS.
Patients fulfilling the inclusion criteria will be enrolled in the study and receive electrocatheter implant. Then, they will be observed for a two-weeks trial period in which the efficacy of the stimulation and the compliance of the patient is evaluated. During this trial a Tonic wave stimulation is administered by the external generator. After this trial, the definitive generator will be implanted. Two weeks of Tonic stimulation will follow the surgery to avoid any interference of the pain measurement with the surgical pain. After this two weeks period, the stimulation will be switched into the combined waveform for 15 days. At the end of the study period, the final waveform setting of the SCS will be in accord with the patient's stimulation preference.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Refractory neuropathic leg and low back pain | Experimental | Device: Burst + TonicPatients with refractory neuropathic leg and low back pain as result of FBSS will be enrolled in the study and receive electrocatheter implant. Then, they will be observed for a two-weeks trial period in which the efficacy of the stimulation and the compliance of the patient is evaluated. During this trial a Tonic wave stimulation is administered by the external generator. After the trial, the definitive generator will be implanted. Tonic stimulation will be selected as wave form for four weeks. After this period, the stimulation will be switched into the combined waveform for 30 days. At the end of the study period, the final waveform setting of the SCS will be in accord with the patient's stimulation preference. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Chronic, persistent, refractory, low back pain as a result of spinal surgery
- Failed conservative treatments for chronic pain including but not limited to pharmacological therapy, physical therapy and minimally interventional pain procedures for chronic pain
- Pain radiating in the leg, following segments L4 and/or L5 and/or S1 for at least 6 months
- Minimum baseline pain intensity as assessed by VAS of ≥ 50mm on 100mm scale in the primary pain area
- Subject is able and willing to provide informed consent
Key exclusion criteria (12 listed)
- Back pain component of more than 20% or VAS > 40mm on 100mm scale
- Bilateral limb pain
- Subjects with a previous SCS implantation
- Changes in pain medication in the 2 months preceding the trial period
- Expected inability of subjects to correctly operate the neurostimulation 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 |
|---|---|---|
| Burst + TonicPatients fulfilling the inclusion criteria will be enrolled in the study and receive electrocatheter implant (Precision Spectra system, Boston Scientific). Then, they will be observed for a two-weeks trial period in which the efficacy of the stimulation and the compliance of the patient is evaluated. During this trial a Tonic wave stimulation is administered by the external generator. After the trial, the definitive generator will be implanted. Tonic stimulation will be selected as wave form for four weeks. After this period, the stimulation will be switched into the combined waveform for 30 days. At the end of the study period, the final waveform setting of the SCS will be in accord with the patient's stimulation preference. | Device | Refractory neuropathic leg and low back pain |
Primary outcome
Change in Pain Suppression
Time frame: Baseline (pre intervention), 15 days and 30 days of Tonic Stimulation, 15 days and 30 days of Combined Stimulation
Pain suppression by "Tonic" and "Burst+Tonic" waves Spinal Cord Stimulation, in relation at measure previous of implant, expressed with Numerical Rate Scale (NRS)
10 secondary outcomes
Change in quality of Life
Time frame: Baseline (pre intervention), 15 days and 30 days of Tonic Stimulation, 15 days and 30 days of Combined Stimulation
Change in energy use of the battery
Time frame: 15 days and 30 days of Tonic Stimulation, 15 days and 30 days of Combined Stimulation
Change in halving the pain
Time frame: 15 days and 30 days of Tonic Stimulation, 15 days and 30 days of Combined Stimulation
Change in use of rescue medication
Time frame: Baseline (pre intervention), 15 days and 30 days of Tonic Stimulation, 15 days and 30 days of Combined Stimulation
Change in number of stimulation adjustments
Time frame: 15 days and 30 days of Tonic Stimulation, 15 days and 30 days of Combined Stimulation
Change in discomfort due to stimulation
Time frame: 15 days and 30 days of Tonic Stimulation, 15 days and 30 days of Combined Stimulation
Change in disability
Time frame: Baseline (pre intervention), 15 days and 30 days of Tonic Stimulation, 15 days and 30 days of Combined Stimulation
Change in subject's satisfaction
Time frame: Baseline (pre intervention), 15 days and 30 days of Tonic Stimulation, 15 days and 30 days of Combined Stimulation
Change in social life
Time frame: Baseline (pre intervention), 15 days and 30 days of Tonic Stimulation, 15 days and 30 days of Combined Stimulation
Change in sleep pattern
Time frame: Baseline (pre intervention), 15 days and 30 days of Tonic Stimulation, 15 days and 30 days of Combined Stimulation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2017.
- Individual participant dataSharing planned: Undecided
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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.
Massimo Innamorato, MD study director
Ospedale Santa Maria delle Croci
Questions about this trial
What is this clinical trial studying?
A study testing Burst + Tonic in people with Failed Back Surgery Syndrome, run by Massimo Innamorato.
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 6 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 3 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Massimo Innamorato, MD (00393386789153, massimo.innamorato@auslromagna.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Suppression (time frame: Baseline (pre intervention), 15 days and 30 days of Tonic Stimulation, 15 days and 30 days of Combined Stimulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Oct 2017.