A Novel Approach in Spinal Cord Stimulation: a Combination of Burst and Tonic Waveforms.

October 1, 2017 updated by: Massimo Innamorato
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.

Study Overview

Status

Status

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

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.

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 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 (Anticipated)

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.
10

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.)
  • 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

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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: Refractory neuropathic leg and low back pain
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.
Device: Burst + Tonic
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.

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
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)
Baseline (pre intervention), 15 days and 30 days of Tonic Stimulation, 15 days and 30 days of Combined Stimulation

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
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
Oswestry Disability Index
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
Energy use index (0-10): Software calculated index indicating energy consumption of the device in relation with stimulation parameters
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
Percentage of subjects with 50% reduction in pain
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
Number of times in which the patient required rescue medication in a period
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
Number of amplitude adjustments in stimulation period
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
Question: are the paresthesia in the limbs acceptable? Yes/No
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
Oswestry Disability Index
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
Oswestry Disability Index
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
Oswestry Disability Index
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
Oswestry Disability Index
Baseline (pre intervention), 15 days and 30 days of Tonic Stimulation, 15 days and 30 days of Combined Stimulation

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.
Massimo Innamorato

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Massimo Innamorato, MD, Ospedale Santa Maria delle Croci

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 (Anticipated)

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.
December 1, 2017

Primary Completion (Anticipated)

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.
December 30, 2018

Study Completion (Anticipated)

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.
December 31, 2018

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).
June 16, 2017

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.
June 25, 2017

First Posted (Actual)

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.
June 28, 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.
October 3, 2017

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.
October 1, 2017

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.
October 1, 2017

More Information

Terms related to this study

Keywords

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.
  • TONIC+BURST

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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