Trials / Unknown
UnknownNCT05624814
Psychological Evaluation After SCS Implantation
Long-term Psychological Evaluation of Patients With Implanted Spinal Cord Stimulator
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 60 (estimated)
- Sponsor
- University Magna Graecia · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | 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. |
| OTHER | Standard therapies | Standard therapies for chronic low back pain are pharmacological, psychological, physical and occupational therapies or surgery. |
Timeline
- Start date
- 2023-01-01
- Primary completion
- 2023-12-31
- Completion
- 2023-12-31
- First posted
- 2022-11-22
- Last updated
- 2022-11-22
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT05624814. Inclusion in this directory is not an endorsement.