Spinal Cord Stimulation (SCS)NCT06761300
Psychological Assessment in Patients Treated with Spinal Cord Stimulation
An observational study of Spinal Cord Stimulation (SCS) and Chronic Pain, run by European Institute of Oncology at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Stimulation (SCS), Chronic Pain
- What is being tested?
- Psychological assessment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 9 Apr 2024to 1 Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Psychiatric disorders or conditions that might impair the ability to give informed consent
- Comorbidity that may impact on compliance to study procedures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Massimo Pezzolato contact
Italy1 site, 1 recruiting
- Recruiting
European Institute of Oncology
Milan, Italy, 20141
Gabriella Pravettoni, +390257489731, gabriella.pravettoni@ieo.it
Massimo Pezzolato, massimo.pezzolato@ieo.it
About this study
Official title: 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
Read the 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.
- Conditions
- Spinal Cord Stimulation (SCS), Chronic Pain
- Being tested
- Psychological assessment
- Keywords
- Spinal Cord Stimulation, chronic pain
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological assessmentOther
Psychological assessment evaluation at different time points and its correlation with pain outcomes and satisfaction with the SCS intervention.
| Study group | Role | What they receive |
|---|---|---|
| patients with chronic pain | Patients suffering from chronic pain treated with Spinal Cord Stimulation Receives: Other: Psychological assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 8 months
Secondary outcomes (1)
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.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start9 Apr 2024
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord Stimulation (SCS)Studies of the same condition, open and under way.
- More trials run by European Institute of OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gabriella Pravettoni, Principal investigator, European Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06761300
- Sponsor's protocol ID
- IEO 2028
- Status last verified
- Dec 2024
- First submitted
- 25 Nov 2024
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Marzorati C, Pezzolato M, Didier F, Borgogni F, Fodor CI, Meneghin S, Guardamagna VA, Pravettoni G. Psychological assessment in patients suffering from chronic pain treated with Spinal Cord Stimulation: A prospective observational study protocol. PLoS One. 2026 Jul 14;21(7):e0352398. doi: 10.1371/journal.pone.0352398. eCollection 2026.
PubMed 42447077
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Assessment in Patients Suffering from Chronic Pain Treated with Spinal Cord Stimulation
- ClinicalTrials.gov ID
- NCT06761300
- Acronym / sponsor ID
- IEO 2028
- Conditions
- Spinal Cord Stimulation (SCS), Chronic Pain
- Keywords
- Spinal Cord Stimulation, chronic pain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- 9 Apr 2024 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 7 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with chronic pain | – | Other: Psychological assessmentPatients suffering from chronic pain treated with Spinal Cord Stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Psychiatric disorders or conditions that might impair the ability to give informed consent
- Comorbidity that may impact on compliance to study procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychological assessmentPsychological assessment evaluation at different time points and its correlation with pain outcomes and satisfaction with the SCS intervention. | Other | patients with chronic pain |
Primary outcome
Evaluation of pain reduction
Time frame: 8 months
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.
Evaluation of removal of SCS
Time frame: 8 months
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.
Evaluation of satisfaction.
Time frame: 8 months
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.
1 secondary outcome
The perceived benefits of psychological counseling throughout the care pathway.
Time frame: 8 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Derived from this study: PubMed 42447077Marzorati C, Pezzolato M, Didier F, Borgogni F, Fodor CI, Meneghin S, Guardamagna VA, Pravettoni G. Psychological assessment in patients suffering from chronic pain treated with Spinal Cord Stimulation: A prospective observational study protocol. PLoS One. 2026 Jul 14;21(7):e0352398. doi: 10.1371/journal.pone.0352398. eCollection 2026.
- Individual participant dataSharing planned: No
Related trials for Spinal Cord Stimulation (SCS)
Recruiting
Adaptive Recruitment Curve Analysis Using Bayesian Modeling
Modeling of Recruitment Curves
Recruiting
Transcutaneous Spinal Stimulation for Children and Youth With Spina Bifida
Myelomeningocele, Spina Bifida
Recruiting
Transcutaneous Spinal Cord Stimulation Combined With 4-Aminopyridine and Intensive Rehabilitation in SCI
Spinal Cord Injuries
RecruitingObservational study
Post Market Evaluation of Real World Outcomes and Durability to Support Implantable Inceptiv™ Spinal Cord Stimulation Therapy
Chronic Pain, Intractable Pain
Recruiting
Hand and Arm Motor Recovery Via Non-invasive Electrical Spinal Cord Stimulation After Stroke
Stroke, Ischemic, Chronic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Massimo Pezzolato contact
Gabriella Pravettoni principal investigator
European Institute of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Stimulation (SCS) and Chronic Pain, run by European Institute of Oncology at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gabriella Pravettoni (0039 02 57489731, gabriella.pravettoni@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of pain reduction (time frame: 8 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06761300, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025.