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

Active, not recruiting

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

• Registration Number: NCT04737746
• Lead Sponsor: AZ Delta

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2021-01-18
• Study First Submitted: 2021-01-26
• Study First Submitted QC: 2021-01-29
• Study First Posted: 2021-02-04
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-20
• Last Update Posted: 2023-02-21
• Primary Completion: 2024-04-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
caregiver strain index	baseline to 12 months
Zarit Burden index	baseline to 12 months	Zarit Burden index measures the burden of a caregiver in 12 questions
relation quality index caregiver	baseline to 12 months

Secondary Outcome Measures

Name	Time	Method
NRS pain leg and back	baseline to 12 months	numeric rating scale
Oswestry Disability Index	baseline to 12 months
EuroQol five dimensions EQ-5D	baseline to 12 months
relation quality index patient	baseline to 12 months
analgetics dose	baseline to 12 months	analgetics ( paracetamol, opiates, opioids, non steroidal anti inflammatory and anti neuropathic pain medication

Trial Locations

Locations (2)

Jan Ypermanziekenhuis; 🇧🇪 Ieper, Belgium

AZ Delta; 🇧🇪 Roeselare, Belgium