Validating and Evaluating the Pain Medicine Digital Workflow Algorithm (PGS 1.0)
ConditionChronic Pain
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorPG Medical Systems Ltd.
About this trial
This is a prospective, non-randomized, double blind, single center, single arm, validation study, to evaluate the performance of PGS 1.0 algorithm in analyzing pain specific symptoms and medical history data of pain patients referred to a pain expert consultation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient is willing and capable of providing Informed Consent.
Pain persisting for at least 1 month.
Disqualifiers
None
Trial population
Male and Female patients aged 18-80, consecutively all patients referred to a pain expert.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Agreement by percent agreement
Interrater reliability defined as the agreement between the PGS 1.0 algorithm and Pain Expert in rating pain patients' pain diagnosis as measured by percent agreement.
Time frame
At the completion of patients' enrollment, agreement will be assessed between PGS 1.0 diagnosis and the expert diagnosis per patient (diagnosis of expert at the intake to the pain clinic and PGS 1.0 diagnosis as per the data the patient filled in).Secondary outcomes
1
Agreement by Cohen's Kappa coefficient.
Interrater reliability defined as the agreement between the PGS 1.0 algorithm and Pain Expert in rating pain patients' diagnosis as measured by Cohen's Kappa coefficient.
Time frame
At the completion of patients' enrollment, agreement will be assessed between PGS 1.0 diagnosis and the expert diagnosis per patient (diagnosis of expert at the intake to the pain clinic and PGS 1.0 diagnosis as per the data the patient filled in).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov