Psychological Assessment in Patients Treated with Spinal Cord Stimulation

European Institute of Oncology

Status: Enrolling

Conditions: Chronic Pain; Spinal Cord Stimulation (SCS)

Treatments: Other: Psychological assessment

Study type: Observational

Funder types: Other

Identifiers

NCT06761300

IEO 2028

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 1 patient group

patients with chronic pain

Description:

Patients suffering from chronic pain treated with Spinal Cord Stimulation

Treatment:

Other: Psychological assessment