Psychological Assessment in Patients Treated with Spinal Cord Stimulation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Psychological assessment.
- Who it may be relevant to
- Registry conditions: Spinal Cord Stimulation (SCS), Chronic Pain. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Psychological Assessment in Patients Suffering from Chronic Pain Treated with Spinal Cord Stimulation
Overview
This is a prospective observational study to investigate the impact of spinal cord stimulation (SCS) procedure in chronic pain perception and management. Patients' psychological status at different time points and its correlation with pain outcomes and satisfaction with the SCS intervention will be also evaluated. The primary aim is to study the associations between psychological variables and intervention outcomes (pain reduction, satisfaction, removal of SCS). Our hypothesis is that people with higher scores in anxiety and depression symptoms would report lower satisfaction with SCS procedure and higher levels of perceived pain after the implantation of the device
Detailed description
More than 30% of people worldwide suffer from chronic pain (CP), defined as "an unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage".
Patients suffering from CP in charge of the Palliative Care and Pain Therapy Division at the European Institute of Oncology IRCCS (Milan, Italy) will be proposed to undergo SCS surgical implantation to mitigate pain symptoms.
The SCS surgical implantation is a two-step procedure; after the hospital admission, a temporary SCS device will be firstly implanted. In this way patients have the possibility to experiment the device impact on their CP conditions, to familiarize with the external device and adjust to its presence, and to eventually grow their motivation toward the implantation of the permanent device. Only after one month, if the patients are convinced of the intervention utility, the temporary device will be changed with a permanent one.
After the medical consultation, patients accepting the surgical procedure and meeting the inclusion criteria will be invited to participate to the study.
Patients signing the Informed Consent will receive a link to complete a set of questionnaires investigating psychological well-being, the impact of chronic pain in daily activities and the decision-making process to undergo to a surgical procedure. Participants who will not be able to complete the online form, will fill it on paper. Patients will complete different questionnaires at different time-points before and after the two-step SCS implantation.
Interventions
- Other Psychological assessment
Psychological assessment evaluation at different time points and its correlation with pain outcomes and satisfaction with the SCS intervention.
Primary outcome measures
- Evaluation of pain reduction [Time frame: 8 months]
- Evaluation of removal of SCS [Time frame: 8 months]
- Evaluation of satisfaction. [Time frame: 8 months]
Secondary outcome measures (1)
- The perceived benefits of psychological counseling throughout the care pathway. [Time frame: 8 months]
Eligibility criteria
Inclusion criteria
- Patients suffering from chronic pain (VAS>4) from at least 6 months
- Patient eligible for SCS implantation
- Age >18 years old
- Willingness and ability to comply with scheduled visits and other trial procedures
- Understanding and speaking Italian language
- Written informed consent
Exclusion criteria
- Psychiatric disorders or conditions that might impair the ability to give informed consent
- Comorbidity that may impact on compliance to study procedures
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Italy · 1 center
- European Institute of Oncology — Milan
Publications
- Marzorati C, Pezzolato M, Didier F, Borgogni F, Fodor CI, Meneghin S, Guardamagna VA, Pravettoni G. Psychological assessment in patients suffering from chronic pain treated with Spinal Cord Stimulation: A prospective observational study protocol. PLoS One. 2026 Jul 14;21(7):e0352398. doi: 10.1371/journal.pone.0352398. eCollection 2026. PMID 42447077
Identifiers
NCT: NCT06761300 · IEO 2028