Psychological Evaluation After SCS Implantation

NCT ID: NCT05624814

Last Updated: 2022-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Psychological Disability Cognitive Impairment Quality of Life

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Experimental group

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

Spinal Cord Stimulation

Intervention Type DEVICE

Spinal Cord Stimulation consists of the transcutaneous or surgical implantation of different types of electrodes in the epidural space; electrodes are then connected to an Implanted Pulse Generator that generates stimulating currents.

Comparison group

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

Standard therapies

Intervention Type OTHER

Standard therapies for chronic low back pain are pharmacological, psychological, physical and occupational therapies or surgery.

Control group

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

No interventions assigned to this group

Interventions

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Spinal Cord Stimulation

Spinal Cord Stimulation consists of the transcutaneous or surgical implantation of different types of electrodes in the epidural space; electrodes are then connected to an Implanted Pulse Generator that generates stimulating currents.

Intervention Type DEVICE

Standard therapies

Standard therapies for chronic low back pain are pharmacological, psychological, physical and occupational therapies or surgery.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Magna Graecia

OTHER

Sponsor Role lead

Responsible Party

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Federico Longhini

Director of the Intensive Care and Anesthesia Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Federico Longhini, MD

Role: PRINCIPAL_INVESTIGATOR

Magna Graecia University

Locations

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AOU Mater Domini

Catanzaro, , Italy

Site Status

Countries

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Italy

Central Contacts

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Federico Longhini, MD

Role: CONTACT

+393475395967

Other Identifiers

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Psico-SCS

Identifier Type: -

Identifier Source: org_study_id

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