Psychological Assessment in Patients Treated with Spinal Cord Stimulation

NCT06761300 | Recruiting

• 1 other identifier: IEO 2028
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Spinal Cord Stimulation (SCS); Chronic Pain

Keywords

Spinal Cord Stimulation; chronic pain

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• The perceived benefits of psychological counseling throughout the care pathway.

  8 months

Study Arms (1)

patients with chronic pain

Patients suffering from chronic pain treated with Spinal Cord Stimulation

Other: Psychological assessment

Interventions

Psychological assessment OTHER

Psychological assessment evaluation at different time points and its correlation with pain outcomes and satisfaction with the SCS intervention.

patients with chronic pain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (1)

European Institute of Oncology

Milan, Italy, 20141, Italy

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gabriella Pravettoni

  European Institute of Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriella Pravettoni

CONTACT

0039 02 57489731; gabriella.pravettoni@ieo.it

Massimo Pezzolato

CONTACT

massimo.pezzolato@ieo.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: January 7, 2025
• Study Start: April 9, 2024
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: January 7, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)