Prevalence of Pain in Hospitalized Cirrhotic Patients
NCT06062108
Acute Pain, Chronic Pain
Draguignan, Var, France
View Trial DetailsNCT Number: NCT04737746
Prospective multicentric observational trial on caregiver burden, caregiver satisfaction and clinical outcome in spinal cord stimulation for chronic neuropathic pain.
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Notify Me18 year and older
All sexes
Observational
Jan Ypermanziekenhuis, Ieper, Belgium
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: baseline to 12 months
Zarit Burden index measures the burden of a caregiver in 12 questions
Time frame: baseline to 12 months
Time frame: baseline to 12 months
Time frame: baseline to 12 months
numeric rating scale
Time frame: baseline to 12 months
Time frame: baseline to 12 months
Time frame: baseline to 12 months
Time frame: baseline to 12 months
analgetics ( paracetamol, opiates, opioids, non steroidal anti inflammatory and anti neuropathic pain medication
AZ Delta
Other
Caregiver Burden and Correlation With Clinical Outcome in Spinal Cord
Acronym: CAREstim
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