Failed Back Surgery Syndrome, Pain, Chronic, Pain, Neuropathic
Conditions
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.
Interventions
None listed
Sponsors
AZ Delta
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Zarit Burden index | baseline to 12 months | Zarit Burden index measures the burden of a caregiver in 12 questions |
| relation quality index caregiver | baseline to 12 months | — |
| caregiver strain index | baseline to 12 months | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| relation quality index patient | baseline to 12 months | — |
| NRS pain leg and back | baseline to 12 months | numeric rating scale |
| analgetics dose | baseline to 12 months | analgetics ( paracetamol, opiates, opioids, non steroidal anti inflammatory and anti neuropathic pain medication |
| Oswestry Disability Index | baseline to 12 months | — |
| EuroQol five dimensions EQ-5D | baseline to 12 months | — |
Countries
Belgium
Outcome results
None listed