Long-term Psychological Evaluation of Patients With Implanted Spinal Cord Stimulator
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Psychological Disability
- Sponsor
- University Magna Graecia
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Global Cognitive Functioning - Montreal Cognitive Assessment
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Federico Longhini
Director of the Intensive Care and Anesthesia Department
University Magna Graecia
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
Outcomes
Primary Outcomes
Global Cognitive Functioning - Montreal Cognitive Assessment
Time Frame: At patient's inclusion
Montreal Cognitive Assessment provides screening of global cognitive functioning; it is composed of 12 subtasks exploring: memory; visuospatial abilities assessed by a clock-drawing task and by copying of a cube; executive functions assessed by means of a brief version of the Trail Making B task, a phonemic fluency task, and a two-item verbal abstraction task; attention, concentration and working memory assessed by means of a sustained attention task (target detection using tapping), a serial subtraction task, and forward and backward span tasks for digits; language assessed by a naming task with low-familiarity animals, repetition of two syntactically complex sentences and the above-mentioned phonemic fluency task; temporal and spatial orientation.
Global Cognitive Functioning - Raven's Colored Progressive Matrices Test
Time Frame: At patient's inclusion
The Raven's Colored Progressive Matrices Test assesses abstract reasoning abilities with nonverbal material. The test consists of 36 matrices, grouped into 3 sets of increasing difficulty. Each matrix has a missing piece that the subject must choose from six alternatives available. The total score ranges from 0 to 36 and is obtained by summing the number of correct answers.
Secondary Outcomes
- Metacognition - Multifactorial Memory Questionnaire(At patient's inclusion)
- Metacognition - Adult Executive Functioning Inventory(At patient's inclusion)
- Quality of life(At patient's inclusion)
- Metacognition - Memory Assessment Clinics-Questionnaire(At patient's inclusion)
- Behavioral Symptomatology - Beck Depression Inventory(At patient's inclusion)
- Behavioral Symptomatology - State-Trait Anxiety Inventory(At patient's inclusion)
- Behavioral Symptomatology - Apathy Evaluation Scale(At patient's inclusion)
- Pain - Numeric Rating Scale(At patient's inclusion)
- Disability - Roland Morris Disability Questionnaire(At patient's inclusion)
- Pain and disability - Pain Catastrophizing Scale(At patient's inclusion)
- Resilience, Perceived Self-efficacy, and Coping Styles - Brief Resilience Scale(At patient's inclusion)
- Resilience, Perceived Self-efficacy, and Coping Styles - Pain Self-Efficacy Questionnaire(At patient's inclusion)
- Resilience, Perceived Self-efficacy, and Coping Styles - Coping Scale(At patient's inclusion)
- Interoception - Heartbeat Detection Task(At patient's inclusion)
- Interoception - Self Awareness Questionnaire(At patient's inclusion)
- Interoceptive awareness(At patient's inclusion)