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| ID | Type | Description | Link |
|---|---|---|---|
| CME AZ Delta | Other Identifier | Studie 20130 |
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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Zarit Burden index | Zarit Burden index measures the burden of a caregiver in 12 questions | baseline to 12 months |
| relation quality index caregiver | baseline to 12 months | |
| caregiver strain index | baseline to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| NRS pain leg and back | numeric rating scale | baseline to 12 months |
| Oswestry Disability Index | baseline to 12 months | |
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Inclusion Criteria:
Exclusion Criteria:
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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)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jan Ypermanziekenhuis | Ieper | 8900 | Belgium | |||
| AZ Delta |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D009437 | Neuralgia |
| D055111 | Failed Back Surgery Syndrome |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| EuroQol five dimensions EQ-5D |
| baseline to 12 months |
| relation quality index patient | baseline to 12 months |
| analgetics dose | analgetics ( paracetamol, opiates, opioids, non steroidal anti inflammatory and anti neuropathic pain medication | baseline to 12 months |
| Roeselare |
| 8800 |
| Belgium |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D001416 | Back Pain |