Pain Reprocessing Therapy for chronic orofacial pain
Official title: Reprocessing The Fear Of Pain - A Cognitive-Behavioral Protocol For Chronic Primary Orofacial Pain Diseases.
Run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta · NCT07123233 · Data updated 2026-11-12
This study will try Pain Reprocessing Therapy, a CBT-based psychotherapy, to reduce pain and improve function in adults with chronic primary orofacial pain who report moderate to severe pain.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta Academic / other |
| Locations | 1 site (Milan) |
| Status | Recruiting |
| Started | September 24, 2025 |
| Main results expected | May 2028 |
| Study ends | May 2028 |
| Registry record updated | November 5, 2026 |
| Trial ID | NCT07123233 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–70 with a formal ICD-11 diagnosis of Chronic Primary Orofacial Pain or Persistent Idiopathic Facial Pain who report average pain ≥4/10 and can participate in psychotherapy are ideal candidates.
✕Probably not a fit
Patients with pain from clear structural lesions, active cancer, major inflammatory disease, recent stroke or neurosurgery, severe psychotic disorders, those on immunosuppressants, or those unable to engage in psychotherapy (including people over 70 as excluded) are unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized clinical trial at the IRCCS Carlo Besta Neurological Institute compares Pain Reprocessing Therapy (a cognitive-behavioral psychotherapy) to usual therapy for adults with Chronic Primary Orofacial Pain (CPOP)/Persistent Idiopathic Facial Pain (PIFP). Eligible participants are adults aged 18–70 with an ICD-11 diagnosis of CPOP and average pain of 4/10 or higher on the Brief Pain Inventory; multiple medical and psychiatric exclusions apply. The trial tests whether a psychological treatment aimed at nociplastic pain and altered brain connectivity can reduce pain and improve daily function without relying primarily on medications. Outcomes will follow standard pain and function measures used in prior chronic pain studies.
Why it matters
Potential benefit: If successful, this approach could reduce pain and improve daily functioning for people with CPOP while minimizing reliance on medications.
How similar studies have gone: Related Pain Reprocessing Therapy and CBT-based programs have shown positive results in other types of primary chronic pain, but applying PRT specifically to CPOP is a novel extension.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of Chronic Primary Orofacial Pain (CPOP) according to ICD-11 criteria. * Patient-reported pain rating of 4 or higher out of 10 on the Brief Pain Inventory (BPI) question assessing average pain over the past week, consistent with inclusion criteria from previous chronic pain studies. * Written informed consent. * Age 18 years or older. Exclusion Criteria: * Age over 70 years. * Current use of immunosuppressive medications (e.g., steroids). * History of cancer (breast, thyroid, prostate, blood cancers, etc.). * History of stroke, neurosurgical interventions, or brain tumors. * History of specific inflammatory diseases (lupus, scleroderma, rheumatoid arthritis, polymyalgia rheumatica). * History of psychiatric disorders such as schizophrenia, personality disorders, dissociative identity disorder, or other severe psychoses. * Unexpected or unintentional weight loss of 10 kg or more in the year prior to recruitment. * Difficulty participating due to logistical problems. * Contraindications to undergoing functional magnetic resonance imaging (fMRI). * Psychotherapy treatment of any kind within 15 months prior to the assessment date.
Where it's running
-
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, Italy Recruiting
Study contacts
- Principal investigator: Licia Grazzi, MD — Fondazione IRCCS Istituto Neurologico Carlo Besta
- Study coordinator: Licia Grazzi, MD
- Email: licia.grazzi@istituto-besta.it
- Phone: + 39 02.2394
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.