Actively Recruiting
Psychological Assessment in Patients with Chronic Pain Treated with Spinal Cord Stimulation
Led by European Institute of Oncology · Updated on 2025-01-07
50
Participants Needed
1
Research Sites
90 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how spinal cord stimulation (SCS) affects chronic pain perception and management. This observational study focuses on patients with chronic pain attending the Palliative Care and Pain Therapy Division at the European Institute of Oncology IRCCS in Milan, Italy. It investigates the relationship between psychological factors, such as anxiety and depression, and outcomes like pain reduction, satisfaction with the SCS procedure, and whether the device is removed. The study hypothesizes that higher anxiety and depression may lead to less satisfaction and more pain after SCS implantation. The SCS implantation involves a two-step surgical process. Initially, patients receive a temporary SCS device during hospital admission to experience its impact on their chronic pain, get accustomed to the device, and decide whether to proceed. After one month, if convinced, the temporary device is replaced with a permanent implant. Patients who accept the surgery and meet the study criteria are invited to participate and complete psychological and pain-related questionnaires at multiple time points before and after the implantation. Participants will complete questionnaires online or on paper to assess psychological well-being, the effect of chronic pain on daily life, and decision-making about surgery. The study tracks pain reduction, device removal, and satisfaction over an eight-month period. Researchers monitor psychological status and its impact on these outcomes, aiming to understand better how mental health influences the success of SCS in managing chronic pain.
CONDITIONS
Official Title
Psychological Assessment in Patients Treated with Spinal Cord Stimulation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients suffering from chronic pain with a pain score greater than 4 for at least 6 months
- Patient eligible for spinal cord stimulation implantation
- Age over 18 years old
- Willingness and ability to comply with scheduled visits and other trial procedures
- Understanding and speaking Italian language
- Written informed consent
You will not qualify if you...
- Psychiatric disorders or conditions that impair the ability to give informed consent
- Comorbidities that may affect compliance with study procedures
AI-Screening
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Trial Site Locations
Total: 1 location
1
European Institute of Oncology
Milan, Italy, Italy, 20141
Actively Recruiting
Research Team
G
Gabriella Pravettoni
M
Massimo Pezzolato
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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