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Completed

NCT Number: NCT04737746

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Jan Ypermanziekenhuis, Ieper, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Zarit Burden index

    Time frame: baseline to 12 months

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

  2. relation quality index caregiver

    Time frame: baseline to 12 months

  3. caregiver strain index

    Time frame: baseline to 12 months

Secondary outcomes

  1. NRS pain leg and back

    Time frame: baseline to 12 months

    numeric rating scale

  2. Oswestry Disability Index

    Time frame: baseline to 12 months

  3. EuroQol five dimensions EQ-5D

    Time frame: baseline to 12 months

  4. relation quality index patient

    Time frame: baseline to 12 months

  5. analgetics dose

    Time frame: baseline to 12 months

    analgetics ( paracetamol, opiates, opioids, non steroidal anti inflammatory and anti neuropathic pain medication

Sponsors and collaborators

Lead sponsor

AZ Delta

Other

Registry information

Official study title

Caregiver Burden and Correlation With Clinical Outcome in Spinal Cord

Acronym: CAREstim

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Feb 4, 2021
Registry last updated
Jul 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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