Clinical trial NCT04737746: Caregiver Burden and Correlation With Clinical Outcome in Spinal Cord Stimulation for Chronic Neuropathic Pain
Official title: Caregiver Burden and Correlation With Clinical Outcome in Spinal Cord
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pain, Chronic
Pain, Neuropathic
Failed Back Surgery Syndrome
Lead sponsor: AZ Delta
Sponsor class: OTHER
First posted: 2021-02-04
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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)

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.

Eligibility criteria: 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

Primary outcomes:
measure: Zarit Burden index
timeFrame: baseline to 12 months
measure: relation quality index caregiver
timeFrame: baseline to 12 months
measure: caregiver strain index
timeFrame: baseline to 12 months
Secondary outcomes:
measure: NRS pain leg and back
timeFrame: baseline to 12 months
measure: Oswestry Disability Index
timeFrame: baseline to 12 months
measure: EuroQol five dimensions EQ-5D
timeFrame: baseline to 12 months
measure: relation quality index patient
timeFrame: baseline to 12 months
measure: analgetics dose
timeFrame: baseline to 12 months
Other outcomes:
Locations:
city: Ieper
country: Belgium
facility: Jan Ypermanziekenhuis
city: Roeselare
country: Belgium
facility: AZ Delta
Study officials:
References: