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Clinical Trials/NCT04737746
NCT04737746
Completed
Not Applicable

Caregiver Burden and Correlation With Clinical Outcome in Spinal Cord

AZ Delta2 sites in 1 country42 target enrollmentJanuary 18, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain, Chronic
Sponsor
AZ Delta
Enrollment
42
Locations
2
Primary Endpoint
caregiver strain index
Status
Completed
Last Updated
10 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 18, 2021
End Date
March 31, 2024
Last Updated
10 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
AZ Delta
Responsible Party
Principal Investigator
Principal Investigator

Dimitri Vanhauwaert

neurosurgeon

AZ Delta

Eligibility Criteria

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

Outcomes

Primary Outcomes

caregiver strain index

Time Frame: baseline to 12 months

Zarit Burden index

Time Frame: baseline to 12 months

Zarit Burden index measures the burden of a caregiver in 12 questions

relation quality index caregiver

Time Frame: baseline to 12 months

Secondary Outcomes

  • Oswestry Disability Index(baseline to 12 months)
  • NRS pain leg and back(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)

Study Sites (2)

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