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

Pain, Chronic Clinical Trial

— CAREstim  

Official title:

Caregiver Burden and Correlation With Clinical Outcome in Spinal Cord

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04737746
• Other study ID #: B1172020000048
• Secondary ID: CME AZ Delta
• Status: Active, not recruiting
• Start date: January 18, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: February 2023
• Source: AZ Delta
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 42
• Est. completion date: June 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Caregiver Burden
• Chronic Pain
• Failed Back Surgery Syndrome
• Neuralgia
• Pain, Chronic
• Pain, Neuropathic

Locations

Country	Name	City	State
Belgium	Jan Ypermanziekenhuis	Ieper
Belgium	AZ Delta	Roeselare

Sponsors (1)

Lead Sponsor	Collaborator
AZ Delta

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Zarit Burden index	Zarit Burden index measures the burden of a caregiver in 12 questions	baseline to 12 months
Primary	relation quality index caregiver		baseline to 12 months
Primary	caregiver strain index		baseline to 12 months
Secondary	NRS pain leg and back	numeric rating scale	baseline to 12 months
Secondary	Oswestry Disability Index		baseline to 12 months
Secondary	EuroQol five dimensions EQ-5D		baseline to 12 months
Secondary	relation quality index patient		baseline to 12 months
Secondary	analgetics dose	analgetics ( paracetamol, opiates, opioids, non steroidal anti inflammatory and anti neuropathic pain medication	baseline to 12 months