Clinical trial NCT06761300: Psychological Assessment in Patients Treated with Spinal Cord Stimulation
Official title: Psychological Assessment in Patients Suffering from Chronic Pain Treated with Spinal Cord Stimulation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Spinal Cord Stimulation (SCS)
Chronic Pain
Keywords: Spinal Cord Stimulation
chronic pain
Lead sponsor: European Institute of Oncology
Sponsor class: OTHER
First posted: 2025-01-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

1. Patients suffering from chronic pain (VAS\>4) from at least 6 months
2. Patient eligible for SCS implantation
3. Age \>18 years old
4. Willingness and ability to comply with scheduled visits and other trial procedures
5. Understanding and speaking Italian language
6. Written informed consent

Exclusion Criteria:

1. Psychiatric disorders or conditions that might impair the ability to give informed consent
2. Comorbidity that may impact on compliance to study procedures

Primary outcomes:
measure: Evaluation of pain reduction
timeFrame: 8 months
measure: Evaluation of removal of SCS
timeFrame: 8 months
measure: Evaluation of satisfaction.
timeFrame: 8 months
Secondary outcomes:
measure: The perceived benefits of psychological counseling throughout the care pathway.
timeFrame: 8 months
Other outcomes:
Locations:
city: Milan
country: Italy
facility: European Institute of Oncology
Study officials:
affiliation: European Institute of Oncology
name: Gabriella Pravettoni
role: PRINCIPAL_INVESTIGATOR
References: