Psychological Evaluation After SCS Implantation

University Magna Graecia

Status: Not yet enrolling

Conditions: Cognitive Impairment; Quality of Life; Psychological Disability

Treatments: Device: Spinal Cord Stimulation; Other: Standard therapies

Study type: Observational

Funder types: Other

Identifiers

NCT05624814

Psico-SCS

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

60 participants in 3 patient groups

Experimental group

Description:

Patients with chronic pain which failed standard therapies and with an implanted Spinal Cord Stimulator

Treatment:

Device: Spinal Cord Stimulation

Comparison group

Description:

Patients with chronic pain following traditional therapies, i.e. pharmacological, psychological, physical and occupational therapies or surgery.

Treatment:

Other: Standard therapies

Control group

Description:

Healthy volunteers matched for age and schooling to those included in the experimental group