Actively Recruiting
An Innovative Cognitive-Behavioral Treatment For Chronic Orofacial Pain
Led by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta · Updated on 2026-02-11
60
Participants Needed
1
Research Sites
135 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Use these resources to provide understandable information about this study to patients, families, and health care providers: The present randomized clinical trial (RCT), conducted at the IRCCS Carlo Besta Neurological Institute, aims to evaluate the effectiveness of Pain Reprocessing Therapy (PRT), a form of psychological support/psychotherapy based on cognitive-behavioral therapy, which has already proven effective in the treatment of other types of primary chronic pain. Chronic Primary Orofacial Pain (CPOP) is a rare and complex form of chronic pain that predominantly affects adult women and occurs without evident lesions, yet has a significant emotional and functional impact. It was recently classified among chronic primary pain conditions in the ICD-11 and is considered a form of nociplastic pain, associated with alterations in brain connectivity. At present, pharmacological treatments have shown limited effectiveness. This randomized clinical trial (RCT), conducted at the IRCCS Carlo Besta Neurological Institute, aims to evaluate the effectiveness of Pain Reprocessing Therapy (PRT), a form of psychological support/psychotherapy based on cognitive-behavioral therapy, which has already proven effective in the treatment of other types of primary chronic pain. Sixty participants, all diagnosed with CPOP according to ICD-11 criteria, will be selected and randomly assigned to two groups: one will receive PRT, the other will receive treatment as usual (TAU). The primary outcome of the study is the assessment of pain intensity reduction. Secondary outcomes include a broad range of psychosocial variables: improvement in quality of life, reduction of anxiety-depressive symptoms, catastrophizing, and other psychopathological traits. The effects of the therapy on brain connectivity will also be analyzed using fMRI, and on pain neurophysiology through the Conditioned Pain Modulation (CPM) paradigm. The protocol provides for the evaluation of therapy effectiveness at three follow-ups (3, 6, and 12 months) in order to measure the duration of effects. Finally, through advanced statistical analysis tools and the support of artificial intelligence, the study also aims to identify specific clinical-neurofunctional profiles that may be useful for differential diagnosis and for tailoring therapeutic interventions.
CONDITIONS
Official Title
An Innovative Cognitive-Behavioral Treatment For Chronic Orofacial Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Chronic Primary Orofacial Pain (CPOP) according to ICD-11 criteria.
- Average pain rating of 4 or higher out of 10 on the Brief Pain Inventory over the past week.
- Written informed consent.
- Age 18 years or older.
You will not qualify if you...
- Age over 70 years.
- Current use of immunosuppressive medications such as steroids.
- History of cancer including breast, thyroid, prostate, and blood cancers.
- History of stroke, neurosurgical interventions, or brain tumors.
- History of inflammatory diseases such as lupus, scleroderma, rheumatoid arthritis, or polymyalgia rheumatica.
- History of severe psychiatric disorders like schizophrenia, personality disorders, dissociative identity disorder, or other psychoses.
- Unintentional weight loss of 10 kg or more in the past year.
- Difficulty participating due to logistical problems.
- Contraindications to functional magnetic resonance imaging (fMRI).
- Psychotherapy treatment within 15 months prior to assessment.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, Italy, 20133
Actively Recruiting
Research Team
L
Licia Grazzi, MD
CONTACT
A
Alessandra Telesca, phd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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