Ignite Creation Date:
2024-05-06 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06229015
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-01-29
First Post:
2024-01-05
Brief Title:
Evaluation of Online Tool E-TOOL SCS in Spinal Cord Stimulaion
Sponsor:
Istituti Clinici Scientifici Maugeri SpA
Organization:
Istituti Clinici Scientifici Maugeri SpA
Study Overview
Official Title:
Evaluation of an Online Tool E-TOOL in the Selection of Patients for Spinal Cord Stimulation for Chronic Pain
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
E-TOOLSCS
Brief 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 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 agreementdisagreement 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
Study Objectives
Primary Objective Evaluate the degree of agreementdisagreement 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 Implanters perspective appropriateness in terms of selecting a patient for SCS as the next step in chronic pain management
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 Implanters perspective appropriateness in terms of selecting a patient for SCS as the next step in chronic pain management
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None