PGS 1.0 digital algorithm for diagnosing and guiding treatment of chronic pain
Prospective Validation and Performance Evaluation of the Algorithm of the Pain Medicine Digital Workflow (PGS 1.0)
This project will test whether the PGS 1.0 algorithm can analyze symptoms and medical history to suggest diagnoses and treatment pathways for patients with chronic pain referred to a pain specialist.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | PG Medical Systems Ltd. Industry-sponsored |
| Locations | 1 site (Haifa) |
| Trial ID | NCT07195162 on ClinicalTrials.gov |
What this trial studies
This is a prospective, non-randomized, double-blind, single-center, single-arm validation of the PGS 1.0 algorithm conducted at the Rambam Pain Institute. Patients (first-time or follow-up) complete an online questionnaire collecting pain-specific symptoms and medical history. The algorithm's diagnoses and recommended pathways will be compared blind to the diagnoses from pain specialists at Rambam. The study measures agreement and diagnostic performance to determine how well the tool matches expert judgment.
Who should consider this trial
Good fit: Patients visiting the Rambam Pain Institute with pain lasting at least one month who can provide informed consent are the intended participants.
Not a fit: Patients with pain under one month, those unable to complete the online questionnaire, or those treated outside Rambam are unlikely to benefit from this validation.
Why it matters
Potential benefit: If successful, the algorithm could speed up diagnosis and appropriate treatment decisions, helping more patients get timely pain care and reducing specialist wait times.
How similar studies have performed: Algorithmic symptom-analysis tools have shown promise in other medical areas but prospective, double-blind validation specifically for chronic pain diagnosis is limited, making this a relatively novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient is willing and capable of providing Informed Consent. * Pain persisting for at least 1 month. Exclusion Criteria: None
Where this trial is running
Haifa
- Pain Medicine Institute, Rambam Health Care Campus — Haifa, Israel (Recruiting)
Study contacts
- Principal investigator: Simon Vulfsons, MD — Rambam Health Care Campus
- Study coordinator: Shany Blum, MD PhD
- Email: shany@pgmeds.com
- Phone: +972545331773
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.