Clinical trial NCT05624814: Psychological Evaluation After SCS Implantation
Official title: Long-term Psychological Evaluation of Patients With Implanted Spinal Cord Stimulator
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Psychological Disability
Cognitive Impairment
Quality of Life
Keywords: Spinal Cord Stimulation
Psychological Disability
Cognitive Impairment
Quality of Life
Metacognition
Pain and Disability
Lead sponsor: University Magna Graecia
Sponsor class: OTHER
First posted: 2022-11-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 60 consecutive patients (20 per cohort) will be enrolled if they meet the inclusion criteria and no exclusion criteria as per cohort.

Brief summary: Spinal cord stimulation (SCS) is a therapeutic option for patients with chronic low back pain (CLBP) syndrome, when pharmacological, psychological, physical and occupational therapies or surgery fail to reduce symptoms. CLBP is a common disease with several negative consequences on the quality of life, work and activity ability and increased costs to the health-care system. We have therefore designed this observational study to assess global cognitive functioning in three different groups of patients: patients with chronic pain undergoing intervention (experimental group), patients with chronic pain following traditional therapies (comparison group) and healthy participants matched for age and schooling (healthy subjects).

A neuropsychological assessment battery designed to assess global cognitive functioning, behavioral symptomatology, metacognition, quality of life, interoception, pain perception, self-efficacy, and coping styles will be conducted.


Eligibility criteria: Inclusion Criteria:

* age greater than 18 years
* presence of chronic pain treated with spinal cord stimulation (Experimental Group)
* presence of chronic pain receiving standard therapies (Comparison Group)
* healthy participants matched for age and schooling (Control Group).

Exclusion Criteria:

* consent denied

Primary outcomes:
measure: Global Cognitive Functioning - Montreal Cognitive Assessment
timeFrame: At patient's inclusion
measure: Global Cognitive Functioning - Raven's Colored Progressive Matrices Test
timeFrame: At patient's inclusion
Secondary outcomes:
measure: Metacognition - Memory Assessment Clinics-Questionnaire
timeFrame: At patient's inclusion
measure: Metacognition - Multifactorial Memory Questionnaire
timeFrame: At patient's inclusion
measure: Metacognition - Adult Executive Functioning Inventory
timeFrame: At patient's inclusion
measure: Quality of life
timeFrame: At patient's inclusion
measure: Behavioral Symptomatology - Beck Depression Inventory
timeFrame: At patient's inclusion
measure: Behavioral Symptomatology - State-Trait Anxiety Inventory
timeFrame: At patient's inclusion
measure: Behavioral Symptomatology - Apathy Evaluation Scale
timeFrame: At patient's inclusion
measure: Pain - Numeric Rating Scale
timeFrame: At patient's inclusion
measure: Disability - Roland Morris Disability Questionnaire
timeFrame: At patient's inclusion
measure: Pain and disability - Pain Catastrophizing Scale
timeFrame: At patient's inclusion
measure: Resilience, Perceived Self-efficacy, and Coping Styles - Brief Resilience Scale
timeFrame: At patient's inclusion
measure: Resilience, Perceived Self-efficacy, and Coping Styles - Pain Self-Efficacy Questionnaire
timeFrame: At patient's inclusion
measure: Resilience, Perceived Self-efficacy, and Coping Styles - Coping Scale
timeFrame: At patient's inclusion
measure: Interoception - Heartbeat Detection Task
timeFrame: At patient's inclusion
measure: Interoception - Self Awareness Questionnaire
timeFrame: At patient's inclusion
measure: Interoceptive awareness
timeFrame: At patient's inclusion
Other outcomes:
Locations:
city: Catanzaro
country: Italy
facility: AOU Mater Domini
Study officials:
affiliation: Magna Graecia University
name: Federico Longhini, MD
role: PRINCIPAL_INVESTIGATOR
References: