Psychological Assessment in Patients Treated with Spinal Cord Stimulation

Psychological Assessment in Patients Suffering from Chronic Pain Treated with Spinal Cord Stimulation

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

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain; Spinal Cord Stimulation (SCS)
• Intervention / Treatment: Other: Psychological assessment

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.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Gabriella Pravettoni; Phone Number: 0039 02 57489731; Email: gabriella.pravettoni@ieo.it
• Study Contact Backup: Name: Massimo Pezzolato; Email: massimo.pezzolato@ieo.it

Study Locations

• Italy
  • Milan, Italy, 20141
    • Recruiting
    • European Institute of Oncology
    • Contact: Gabriella Pravettoni; Phone Number: +390257489731; Email: gabriella.pravettoni@ieo.it
    • Contact: Gabriella Pravettoni
    • Contact: Massimo Pezzolato; Email: massimo.pezzolato@ieo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients with chronic pain; Patients suffering from chronic pain treated with Spinal Cord Stimulation	Other: Psychological assessment; Psychological assessment evaluation at different time points and its correlation with pain outcomes and satisfaction with the SCS intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of pain reduction	The correlation between each psychological variable and pain reduction will be evaluated using the scores of the following validated questionnaires: State-Trait Anxiety Inventory (STAI-Y), Beck Depression Inventory II (BDI-II), Pain Resilience Scale (PRS), Pain Catastrophizing Scale (PCS), and Brief Pain Inventory (BPI) questionnaire. Details on measurement: The correlation will be evaluated using Pearson's correlation coefficient.	8 months
Evaluation of removal of SCS	The correlation between each psychological variable, pain reduction and removal of SCS will be evaluated using the scores of the following validated questionnaires: State-Trait Anxiety Inventory (STAI-Y), Beck Depression Inventory II (BDI-II), Pain Resilience Scale (PRS), Brief Pain Inventory (BPI) and Pain Catastrophizing Scale (PCS). Details on measurement: The correlation will be evaluated using Student's t-test.	8 months
Evaluation of satisfaction.	Patients SCS satisfaction and the correlation between each psychological variable will be evaluated using the scores of the following validated questionnaires: State-Trait Anxiety Inventory (STAI-Y), Beck Depression Inventory II (BDI-II), Pain Resilience Scale (PRS), Pain Catastrophizing Scale (PCS). Patients' satisfaction with the SCS procedure will be measured with the Patients Global Impression of Change (PGIC) questionnaire. Details on measurement: The correlation will be evaluated using Pearson's correlation coefficient.	8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The perceived benefits of psychological counseling throughout the care pathway.	This outcome will be assessed with an open question ("Do you think that the psychological sessions have helped support you along the care pathway? If yes, in which aspects of your experience was it helpful?"). Details on measurement: The perceived benefits of psychological counseling will be evaluated via open questions.	8 months

Collaborators and Investigators

• Sponsor: European Institute of Oncology
• Investigators: Principal Investigator: Gabriella Pravettoni, European Institute of Oncology

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2024
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: November 25, 2024
• First Submitted That Met QC Criteria: December 31, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 31, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: chronic pain; Spinal Cord Stimulation
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: IEO 2028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No