Pain, ChronicCAREstimNCT04737746
Caregiver Burden and Correlation With Clinical Outcome in Spinal Cord Stimulation for Chronic Neuropathic Pain
An observational study of Pain, Chronic and Pain, Neuropathic, run by AZ Delta at 2 sites in Belgium.
Trial summary
Prospective multicentric observational trial on caregiver burden, caregiver satisfaction and clinical outcome in spinal cord stimulation for chronic neuropathic pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Chronic, Pain, Neuropathic, Failed Back Surgery Syndrome
- How many people
- 42 participants
- Where
- 2 sitesBelgium
- Study dates
- 18 Jan 2021to 31 Mar 2024
- How long will I take part?
- 13 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: 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.
Read the 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.
- Medical subject headings
- Chronic Pain, Neuralgia, Failed Back Surgery Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Zarit Burden index
Zarit Burden index measures the burden of a caregiver in 12 questions
Measured: baseline to 12 months
relation quality index caregiver
Measured: baseline to 12 months
caregiver strain index
Measured: baseline to 12 months
Secondary outcomes (5)
NRS pain leg and back
numeric rating scale
Measured: baseline to 12 months
Oswestry Disability Index
Measured: baseline to 12 months
EuroQol five dimensions EQ-5D
Measured: baseline to 12 months
relation quality index patient
Measured: baseline to 12 months
analgetics dose
analgetics ( paracetamol, opiates, opioids, non steroidal anti inflammatory and anti neuropathic pain medication
Measured: baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study start18 Jan 2021
- Primary completion31 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
- Target duration
- 13 Months
Sponsor and investigators
- Lead sponsor
- AZ Delta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dimitri Vanhauwaert, AZ Delta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04737746
- Sponsor's protocol ID
- B1172020000048
- Other IDs
- CME AZ Delta
- Acronym
- CAREstim
- Status last verified
- Jul 2025
- First submitted
- 26 Jan 2021
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caregiver Burden and Correlation With Clinical Outcome in Spinal Cord
- ClinicalTrials.gov ID
- NCT04737746
- Acronym / sponsor ID
- CAREstim / B1172020000048
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- AZ DeltaUniversity, hospital or other
- Study start
- 18 Jan 2021 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 4 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 13 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
5 secondary outcomes
NRS pain leg and back
Time frame: baseline to 12 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Chronic and Pain, Neuropathic, run by AZ Delta at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Zarit Burden index (time frame: baseline to 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2025.