Assessing psychological factors in patients receiving spinal cord stimulation for chronic pain
Psychological Assessment in Patients Suffering from Chronic Pain Treated with Spinal Cord Stimulation
This study looks at how anxiety and depression affect pain relief and satisfaction in patients getting spinal cord stimulation for chronic pain.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | European Institute of Oncology Academic / other |
| Locations | 1 site (Milan, Italy) |
| Trial ID | NCT06761300 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the psychological status of patients undergoing spinal cord stimulation (SCS) for chronic pain management. It will investigate the correlation between psychological variables, such as anxiety and depression, and outcomes related to pain reduction and patient satisfaction with the SCS intervention. Patients will complete questionnaires assessing their psychological well-being and the impact of chronic pain on daily activities before and after the SCS procedure. The study will involve a two-step surgical implantation process, allowing patients to experience the temporary device before committing to a permanent one.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old suffering from chronic pain for at least six months and eligible for spinal cord stimulation implantation.
Not a fit: Patients with psychiatric disorders that impair informed consent or those with comorbidities affecting compliance may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of how psychological factors influence pain management outcomes, leading to improved patient care.
How similar studies have performed: While studies on chronic pain management exist, this specific focus on the psychological assessment in relation to SCS outcomes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Milan, Italy
- European Institute of Oncology — Milan, Italy, Italy (Recruiting)
Study contacts
- Principal investigator: Gabriella Pravettoni — European Institute of Oncology
- Study coordinator: Gabriella Pravettoni
- Email: gabriella.pravettoni@ieo.it
- Phone: 0039 02 57489731
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.