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An Innovative Cognitive-Behavioral Treatment For Chronic Orofacial Pain

RecruitingNAAges 18 Years - 70 YearsAllFondazione I.R.C.C.S. Istituto Neurologico Carlo …
NCT07123233 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 treatm

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📋 Eligibility rules (as published)
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.
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What it tests

  • Pain Reprocessing Therapy
  • Usual Therapy
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Where

1 site
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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