An observational study in Pain, Chronic, Pain, Neuropathic and Failed Back Surgery Syndrome, sponsored by AZ Delta. Completed at 2 sites in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-04.
Sponsored by AZ Delta · Observational
Prospective multicentric observational trial on caregiver burden, caregiver satisfaction and clinical outcome in spinal cord stimulation for chronic neuropathic pain.
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.
3,227 studies on the registry are indexed under Chronic Pain; 729 are open to participants now.
This study's enrollment of 42 is below the median of 120 across 753 observational studies indexed under Chronic Pain.
Browse Chronic Pain studies →AZ Delta is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Zarit Burden index
Zarit Burden index measures the burden of a caregiver in 12 questions
Time frame: baseline to 12 months
relation quality index caregiver
Time frame: baseline to 12 months
caregiver strain index
Time frame: baseline to 12 months
NRS pain leg and back
numeric rating scale
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
analgetics ( paracetamol, opiates, opioids, non steroidal anti inflammatory and anti neuropathic pain medication
Time frame: baseline to 12 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2021 to primary completion in Mar 2024, 38 months.
Of 336 non-industry observational studies under Chronic Pain, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 56. This study's 38 months is above that.
Counting every sponsor, half of 362 studies reached it within 24 months; a quarter within 12 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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