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Psychological Assessment in Patients Treated with Spinal Cord Stimulation

ConditionsSpinal Cord Stimulation (SCS)Chronic Pain
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEuropean Institute of Oncology

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Psychiatric disorders or conditions that might impair the ability to give informed consent

Comorbidity that may impact on compliance to study procedures

Trial 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.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Psychological assessment

    Other intervention

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

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: patients with chronic pain1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
8 months
2

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.

Time frame
8 months
3

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.

Time frame
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.

Time frame
8 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

European Institute of Oncology

Lead sponsor

Source ClinicalTrials.gov
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