Caregiver Burden and Correlation With Clinical Outcome in Spinal Cord Stimulation for Chronic Neuropathic Pain (CAREstim)

AZ Delta

Status: Active, not recruiting

Conditions: Pain, Chronic; Pain, Neuropathic; Failed Back Surgery Syndrome

Study type: Observational

Funder types: Other

Identifiers

NCT04737746

CME AZ Delta (Other Identifier)

B1172020000048

Details and patient eligibility

About

Prospective multicentric observational trial on caregiver burden, caregiver satisfaction and clinical outcome in spinal cord stimulation for chronic neuropathic pain.

Full description

Spinal cord stimulation is an effective therapy for chronic neuropathic pain. After careful selection, the satisfaction for the patient is often considerable. The investigators want to investigate the caregiver burden for relatives of patients who are treated with spinal cord stimulation. This will be evaluated by appropriate scores at baseline, during neurostimulator trial and 3,6 and 12 months after implantation. At the same time the patient satisfaction and pain reduction will also be evaluated independently.

In this prospective cohort different parameters will be assessed at baseline, trial, 3, 6 and 12 months follow-up for the patient and their caregiver.

For the patient this will include Numeric Rating scale (NRS) for leg and back pain, Oswestry Disability Index (ODI), EuroQuality of Life-5 Dimensions score (EQ5D), opiate use and Relation Quality Index (RQI).

For the caregiver the Zarit Burden Index (ZBI), Relation Quality Index (RQI) and Modified Caregiver Strain Index (MCSI).

With regard to the research questions, subgroup analysis will be performed regarding to age, sex, education, neurostimulation pattern, surgical vs percutaneous lead placement, working status of both patient and caregiver and caregiver relation characteristics.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients Age > 18 years
• Patients with an identified spousal or offspring caregiver
• Patients receiving neurostimulator for the first time
• Patient complies to reimbursement criteria for spinal cord stimulation in Belgium

Exclusion criteria

• Non-spinal cord type of neuromodulation (DRG, occipital, peripheral nerve, )
• Revision cases, previous neuromodulation
• Patients unable to consent for this study
• Patients without identified spousal or offspring caregiver