Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT06229015 |
| Other study ID # |
2506 CE |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 13, 2021 |
| Est. completion date |
December 31, 2026 |
Study information
| Verified date |
January 2024 |
| Source |
Istituti Clinici Scientifici Maugeri SpA |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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
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.
