An observational study in Chronic Pain, sponsored by PG Medical Systems Ltd.. Recruiting at 1 site in Israel. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by PG Medical Systems Ltd. · Observational
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.
Background and Rationale:
Chronic pain is a global epidemic. On average, 20% of the Western population suffers from chronic pain, and in some countries, such as the U.S., the number reaches up to 30%. When chronic pain is not properly diagnosed and treated, it leads not only to patient suffering but also to serious comorbidities, increased use of healthcare services, and, in growing numbers, addiction and misuse of prescription drugs.
Pain medicine, a relatively young medical field, offers evidence-based diagnosis and treatment tailored to the patient's pain mechanisms. However, there is a major gap between the large number of patients and the very limited number of pain specialists (around 4,000 in the U.S. and about 80 in Israel). This shortage leads to extremely long waiting times (5-6 months) while patients continue to suffer.
To help close this gap, PG Medical Systems, together with Dr. Simon Wolfson (Head of the Pain Institute at Rambam Health Care Campus), developed an algorithm that analyzes patient symptoms and provides recommendations for pain diagnosis and treatment pathways.
Study Objective:
The study aims to prospectively validate the algorithm's performance by collecting patient data via an online questionnaire at the Rambam Pain Institute. The results will compare the algorithm's diagnoses to those of pain specialists.
Study Procedures:
Patients visiting the Rambam Pain Institute (first-time or follow-up appointments) will be invited to join the study. After signing informed consent, they will complete an online questionnaire with the help of a research assistant. This is a one-time activity, following their medical consultation. The study does not involve additional clinical follow-up. Participation will not affect the patient's diagnosis or treatment.
Duration:
Each participant will spend about 45-60 minutes, including the consent process and questionnaire completion.
Compensation:
Participants will receive 100 NIS for their time.
Data Management and Privacy:
The study will collect only non-identifiable patient data. Each participant will be assigned a code number. Identifying details will remain securely stored at Rambam, linked only by the consent form. This allows for possible follow-up research but ensures that the sponsor company has access only to de-identified data.
Data Security:
All data is stored on Amazon's secure cloud with advanced encryption. Access requires strict authentication, servers are closed to public internet, and only approved private networks can connect. All data is encrypted in transfer and storage. Importantly, the system does not collect identifiable patient information.
3,227 studies on the registry are indexed under Chronic Pain; 729 are open to participants now.
This study's planned enrollment of 200 is above the median of 120 across 753 observational studies indexed under Chronic Pain.
Browse Chronic Pain studies →This is the only study on the registry with PG Medical Systems Ltd. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Male and Female patients aged 18-80, consecutively all patients referred to a pain expert.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
None
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
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).
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.