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

Caregiver Burden and Correlation With Clinical Outcome in Spinal Cord

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

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 42

Contacts and Locations

Study Locations

• Belgium
  • Ieper, Belgium, 8900
    • Jan Ypermanziekenhuis
  • Roeselare, Belgium, 8800
    • AZ Delta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients who are considered to be treated with spinal cord stimulation in AZ Delta hospital and Jan Yperman hospital between 1/1/2021 and 31/12/2021 are potentially eligible for inclusion. The inclusion is not limited to a specific device and all different types of routinely used spinal cord stimulation systems and neurostimulation modalities are included: percutaneous of surgical lead placement in both thoracic or cervical location. All patients follow the standard flow for screening and reimbursement (neuro pain platform and MAO)

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Zarit Burden index	Zarit Burden index measures the burden of a caregiver in 12 questions	baseline to 12 months
relation quality index caregiver		baseline to 12 months
caregiver strain index		baseline to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NRS pain leg and back	numeric rating scale	baseline to 12 months
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	analgetics ( paracetamol, opiates, opioids, non steroidal anti inflammatory and anti neuropathic pain medication	baseline to 12 months

Collaborators and Investigators

• Sponsor: AZ Delta

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2021
• Primary Completion (Actual): March 31, 2024
• Study Completion (Actual): March 31, 2024

Study Registration Dates

• First Submitted: January 26, 2021
• First Submitted That Met QC Criteria: January 29, 2021
• First Posted (Actual): February 4, 2021

Study Record Updates

• Last Update Posted (Actual): July 4, 2025
• Last Update Submitted That Met QC Criteria: July 2, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Neuromuscular Diseases; Behavioral Symptoms; Peripheral Nervous System Diseases; Stress, Psychological; Back Pain; Caregiver Burden; Chronic Pain; Neuralgia; Failed Back Surgery Syndrome
• Other Study ID Numbers: B1172020000048; CME AZ Delta (Other Identifier: Studie 20130)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No