Pain Reprocessing Therapy for chronic orofacial pain

Reprocessing The Fear Of Pain - A Cognitive-Behavioral Protocol For Chronic Primary Orofacial Pain Diseases.

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

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta (Academic / other)
• Locations: 1 site (Milan)
• Trial ID: NCT07123233 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Milan

• 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

Conditions Chronic Primary Orofacial Pain; Persistent Idiopathic Facial Pain; Cognitive-behavioral therapy; Pain-Reprocessing Therapy; Chronic Primary Orofacial pain; chronic pain; chronic primary pain; nociplastic pain