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

Overview

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

Full Title of Study: “Caregiver Burden and Correlation With Clinical Outcome in Spinal Cord”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: April 30, 2024

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.

Clinical Trial Outcome Measures

Primary Measures

  • 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
  • caregiver strain index
    • Time Frame: baseline to 12 months

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • AZ Delta
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dimitri Vanhauwaert, neurosurgeon – AZ Delta

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.