Failed Back Surgery SyndromeE-TOOLSCSNCT06229015
Evaluation of Online Tool (E-TOOL SCS) in Spinal Cord Stimulaion
An observational study of Failed Back Surgery Syndrome and Limb Ischemia, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
Trial summary
This observational multicenter study aims to evaluate the reliability and validity of the e-tool for selecting patients eligible for SCS for chronic pain caused by one of the four etiologies listed above in the experience of daily clinical practice. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Failed Back Surgery Syndrome, Limb Ischemia, Neuropathic Pain
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 13 Jul 2021to 31 Dec 2025
- Phase
- Observational
- 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 16 years and older
- All sexes
- Child, Adult, Older adult
Study population: Patients with chronic pain afferent to pain therapy units in ICS Maugeri hospital Pavia or in University Hospital Pisa
Who may be able to join
- • Males and females aged between 18 and 85 years.
- Patients with chronic pain and indication for implantation of a temporary neurostimulator for spinal cord stimulation testing.
- Signed informed consent.
Who cannot join
- • Patients who, in the researcher's judgment, are unable to follow the protocol instructions.
- Patients in presumed/confirmed pregnancy.
- Contraindications to implantation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of an Online Tool (E-TOOL) in the Selection of Patients for Spinal Cord Stimulation for Chronic Pain
This observational multicenter study aims to evaluate the reliability and validity of the e-tool for selecting patients eligible for SCS for chronic pain caused by one of the four etiologies listed above in the experience of daily clinical practice. The implantation procedure and devices used will be those used in the routine clinical practice of participating centers. Since the study is observational, the use of the e-tool will not replace the routine medical and psychological evaluation in participating centers before SCS implantation.
Study Objectives:
Read more
Primary Objective: Evaluate the degree of agreement/disagreement between the physicians opinion and the e-tool in selecting patients eligible for spinal cord stimulation for chronic pain. Endpoint: Calculation of the probability of disagreement (πD) between the e-tool and the physicians opinion regarding the appropriateness of the intervention.
Secondary Objective: Evaluate the ability of the e-tool to classify interventions defined as appropriate and highly likely to succeed; (scores 7-9) at 3 different time points: trial, 6-month follow-up, and 12-month follow-up. The proportion of interventions that were successful at the trial implantation in different time points will be compared with the proportion of interventions identified as appropriate and highly likely to succeed by the e-tool.
Study Period: 24 months. 12 months of enrollment + 12 months of follow-up. Subjects: Number of subjects to be included: at least 60 (total divided between the two centers)
Participating Centers:
- Pain Therapy Unit - ICSMaugeri, Pavia
- Anesthesia and Pain Therapy SD - Azienda Ospedaliero Universitaria Pisana Pisa
Read the detailed description
Spinal Cord Stimulation (SCS) has been a therapy in the treatment of chronic pain for 50 years, particularly for patients resistant to conventional pharmacological treatment and other less complex invasive procedures. Over the years, various versions of guidelines have been established and drafted for the selection and clinical indications in which SCS therapy is most likely to be successful. The main clinical indications include:
- Chronic pain in the lumbar region and lower limbs, especially in patients who have undergone spine surgeries (Failed Back Surgery Syndrome, FBSS).
- Complex Regional Pain Syndrome (CRPS).
- Peripheral neuropathic pain.
- Ischemic pain in the limbs. In daily clinical practice, the heterogeneity of patients often makes it difficult to determine which patients are eligible for this treatment. A large number of clinical studies suggest that cognitive aspects and individual coping mechanisms in dealing with pain experiences impact treatment response. For this reason, international guidelines recommend that individuals considered for SCS should undergo a comprehensive psychological evaluation.
Recently, an online tool (SCS-e-tool) has been implemented for selecting patients eligible for SCS implantation. Developed by a team of experts in pain therapy with various clinical backgrounds, this tool is freely available online and can be used by healthcare professionals. It is designed to assist in evaluating a patients suitability for spinal cord stimulation and aid in making informed clinical decisions.
The SCS-e-tool takes into account various factors, including cognitive aspects and the patient pain management modalities. The goal is to provide a comprehensive and personalized assessment to identify patients who may benefit most from spinal cord stimulation therapy. This tool can be a valuable aid for healthcare professionals in the decision-making process regarding patient selection for SCS therapy.
It is important to note that, despite the utility of assessment tools, the final decision on a patient candidacy for spinal cord stimulation should be based on a comprehensive evaluation that includes clinical, psychological, and individual aspects of the patient.
The implementation of tools like the SCS-e-tool represents a step forward in the personalized approach to chronic pain management and the optimization of patient selection for specific therapies such as spinal cord stimulation.
Recently, an online tool (SCS-e-tool) has been implemented for the selection of patients eligible for SCS implantation, developed by a pool of experts in pain therapy with diverse clinical profiles. This tool, available online for free and built according to the RUAM method, allows the input of various clinical profiles with diagnostic, clinical, and psychological information and provides indications on the likelihood of SCS success and suggestions regarding the need for psycho-social support therapies in conjunction with neurostimulation.
The e-tool scores range from 1 to 9 and are divided as follows: 1-3 inappropriate intervention, 4-6 intervention with uncertain outcomes, 7-9 appropriate intervention with a high probability of success. The e-tool has a dual use for implanters and referrers. For both groups, the scope is similar, but perspectives differ: Referrers perspective: appropriateness in terms of referring a patient to consider SCS as the next step in chronic pain management. Implanter's perspective: appropriateness in terms of selecting a patient for SCS as the next step in chronic pain management.
- Conditions
- Failed Back Surgery Syndrome, Limb Ischemia, Neuropathic Pain, Complex Regional Pain Syndromes
- Keywords
- Spinal cord stimulation, SCS-E-TOOL, Chronic Pain Treatment
- Medical subject headings
- Failed Back Surgery Syndrome, Neuralgia, Complex Regional Pain Syndromes
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical rating scale
Numeric Rating Scale (NRS): a scale for pain intensity assessment useful for controlling therapies, clinical routine monitoring, and scientific studies. The result is the indication of pain intensity on a scale from 0 to 10, where 0 indicates no pain, and 10 indicates the maximum imaginable pain
Measured: through study completion, an average of 1 year
Secondary outcomes (4)
Evaluate the ability of the E-TOOL to classify interventions defined as appropriate and highly likely to succeed
The proportion of interventions that were successful at the trial implantation will be compared with the proportion of interventions identified as approprite and highly likely to success by the E-TOOL
Measured: perioperatively/periprocedurally
Oswestry Disability Index
Oswestry Disability Index (ODI): a standardized tool for assessing the degree of disability reported by a patient and related to pain symptoms but also to other disabling conditions. It assesses the interference of disability with various aspects of daily life
Measured: through study completion, an average of 1 year
European Quality of life, EuroQol
European Quality of Life, EuroQoL (EQ-5D-5L): a standardized tool that measures the health status of respondents and their quality of life, based on which it is possible to assess the health care provided, a technique, a technology
Measured: through study completion, an average of 1 year
Patient global impression of change (PGIC)
Patient global impression of change (PGIC) is a 7 point scale depicting a patient's rating of overall improvement, and reflects a patient's belief about the efficacy of treatment
Measured: through study completion, an average of 1 year"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start13 Jul 2021
- Primary completion16 Jan 2022
- Study completion31 Dec 2025
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.
- More trials run by Istituti Clinici Scientifici Maugeri SpAThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliero, Universitaria Pisana
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06229015
- Sponsor's protocol ID
- 2506 CE
- Acronym
- E-TOOLSCS
- Status last verified
- Mar 2026
- First submitted
- 5 Jan 2024
- Last updated
- 18 Mar 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Online Tool (E-TOOL) in the Selection of Patients for Spinal Cord Stimulation for Chronic Pain
- ClinicalTrials.gov ID
- NCT06229015
- Acronym / sponsor ID
- E-TOOLSCS / 2506 CE
- Conditions
- Failed Back Surgery Syndrome, Limb Ischemia, Neuropathic Pain, Complex Regional Pain Syndromes
- Keywords
- Spinal cord stimulation, SCS-E-TOOL, Chronic Pain Treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpAUniversity, hospital or other
- Collaborators
- Azienda Ospedaliero, Universitaria Pisana
- Study start
- 13 Jul 2021 (actual)
- Primary completion
- 16 Jan 2022 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 29 Jan 2024 (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.
This observational multicenter study aims to evaluate the reliability and validity of the e-tool for selecting patients eligible for SCS for chronic pain caused by one of the four etiologies listed above in the experience of daily clinical practice. The implantation procedure and devices used will be those used in the routine clinical practice of participating centers. Since the study is observational, the use of the e-tool will not replace the routine medical and psychological evaluation in participating centers before SCS implantation.
Study Objectives:
Primary Objective: Evaluate the degree of agreement/disagreement between the physicians opinion and the e-tool in selecting patients eligible for spinal cord stimulation for chronic pain. Endpoint: Calculation of the probability of disagreement (πD) between the e-tool and the physicians opinion regarding the appropriateness of the intervention.
Secondary Objective: Evaluate the ability of the e-tool to classify interventions defined as appropriate and highly likely to succeed; (scores 7-9) at 3 different time points: trial, 6-month follow-up, and 12-month follow-up. The proportion of interventions that were successful at the trial implantation in different time points will be compared with the proportion of interventions identified as appropriate and highly likely to succeed by the e-tool.
Study Period: 24 months. 12 months of enrollment + 12 months of follow-up. Subjects: Number of subjects to be included: at least 60 (total divided between the two centers)
Participating Centers:
- Pain Therapy Unit - ICSMaugeri, Pavia
- Anesthesia and Pain Therapy SD - Azienda Ospedaliero Universitaria Pisana Pisa
Detailed description
Spinal Cord Stimulation (SCS) has been a therapy in the treatment of chronic pain for 50 years, particularly for patients resistant to conventional pharmacological treatment and other less complex invasive procedures. Over the years, various versions of guidelines have been established and drafted for the selection and clinical indications in which SCS therapy is most likely to be successful. The main clinical indications include:
- Chronic pain in the lumbar region and lower limbs, especially in patients who have undergone spine surgeries (Failed Back Surgery Syndrome, FBSS).
- Complex Regional Pain Syndrome (CRPS).
- Peripheral neuropathic pain.
- Ischemic pain in the limbs. In daily clinical practice, the heterogeneity of patients often makes it difficult to determine which patients are eligible for this treatment. A large number of clinical studies suggest that cognitive aspects and individual coping mechanisms in dealing with pain experiences impact treatment response. For this reason, international guidelines recommend that individuals considered for SCS should undergo a comprehensive psychological evaluation.
Recently, an online tool (SCS-e-tool) has been implemented for selecting patients eligible for SCS implantation. Developed by a team of experts in pain therapy with various clinical backgrounds, this tool is freely available online and can be used by healthcare professionals. It is designed to assist in evaluating a patients suitability for spinal cord stimulation and aid in making informed clinical decisions.
The SCS-e-tool takes into account various factors, including cognitive aspects and the patient pain management modalities. The goal is to provide a comprehensive and personalized assessment to identify patients who may benefit most from spinal cord stimulation therapy. This tool can be a valuable aid for healthcare professionals in the decision-making process regarding patient selection for SCS therapy.
It is important to note that, despite the utility of assessment tools, the final decision on a patient candidacy for spinal cord stimulation should be based on a comprehensive evaluation that includes clinical, psychological, and individual aspects of the patient.
The implementation of tools like the SCS-e-tool represents a step forward in the personalized approach to chronic pain management and the optimization of patient selection for specific therapies such as spinal cord stimulation.
Recently, an online tool (SCS-e-tool) has been implemented for the selection of patients eligible for SCS implantation, developed by a pool of experts in pain therapy with diverse clinical profiles. This tool, available online for free and built according to the RUAM method, allows the input of various clinical profiles with diagnostic, clinical, and psychological information and provides indications on the likelihood of SCS success and suggestions regarding the need for psycho-social support therapies in conjunction with neurostimulation.
The e-tool scores range from 1 to 9 and are divided as follows: 1-3 inappropriate intervention, 4-6 intervention with uncertain outcomes, 7-9 appropriate intervention with a high probability of success. The e-tool has a dual use for implanters and referrers. For both groups, the scope is similar, but perspectives differ: Referrers perspective: appropriateness in terms of referring a patient to consider SCS as the next step in chronic pain management. Implanter's perspective: appropriateness in terms of selecting a patient for SCS as the next step in chronic pain management.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with chronic pain afferent to pain therapy units in ICS Maugeri hospital Pavia or in University Hospital Pisa
Key inclusion criteria (3 listed)
- • Males and females aged between 18 and 85 years.
Key exclusion criteria (3 listed)
- • Patients who, in the researcher's judgment, are unable to follow the protocol instructions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Numerical rating scale
Time frame: through study completion, an average of 1 year
Numeric Rating Scale (NRS): a scale for pain intensity assessment useful for controlling therapies, clinical routine monitoring, and scientific studies. The result is the indication of pain intensity on a scale from 0 to 10, where 0 indicates no pain, and 10 indicates the maximum imaginable pain
4 secondary outcomes
Evaluate the ability of the E-TOOL to classify interventions defined as appropriate and highly likely to succeed
Time frame: perioperatively/periprocedurally
Oswestry Disability Index
Time frame: through study completion, an average of 1 year
European Quality of life, EuroQol
Time frame: through study completion, an average of 1 year
Patient global impression of change (PGIC)
Time frame: through study completion, an average of 1 year"
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 18 Mar 2026.
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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?
An observational study of Failed Back Surgery Syndrome and Limb Ischemia, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
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 3 inclusion and 3 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 18 Mar 2026. 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 Italy. 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?
Numerical rating scale (time frame: through study completion, an average of 1 year). 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 18 Mar 2026.