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NCT Number: NCT07123233

An Innovative Cognitive-Behavioral Treatment For Chronic Orofacial Pain

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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.

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Key information

Conditions

Chronic Primary Orofacial Pain (CPOP) Chronic Pain Neurologic Manifestations Nociplastic Pain Pain Pathological Conditions, Signs and Symptoms Persistent Idiopathic Facial Pain (PIFP) Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pain Reprocessing Therapy

Behavioral

One cohort of 30 patients (PRT+TAU group) will receive eight sessions of Pain Reprocessing Therapy (PRT) in addition to Treatment-as-Usual (TAU). PRT is a cognitive-behavioral-inspired approach aimed at helping patients reinterpret chronic pain as brain-generated rather than structurally caused.

A second cohort of 30 patients (TAU group) will undergo the same assessment phases but will receive only Treatment-as-Usual without PRT.

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Usual Therapy

Behavioral

Patients undergo yhe usual pharmacological tretment as prescrived by neurologist

Primary outcomes

  1. Average pain intensity over the past week.

    Time frame: 12 months

    Average pain intensity over the past week, measured using the Brief Pain Inventory-Short Form (BPI-SF). Score range: 0-10, with higher scores indicating greater pain intensity (worse outcome).

Secondary outcomes

  1. Quality of life (EUROHIS-8)

    Time frame: 12 months

    It includes 8 items scored from 1 to 5 using a 5-point Likert scale investigating the satisfaction on different life domains (i.e., socio-economic conditions, health conditions, satisfaction with oneself and with one's relationships, etc.). A high total score corresponds to a high perception of quality of life.

  2. Depressive and anxiety symptoms (BDI-II, BAI)

    Time frame: 12 months

    BDI-II - It consists of 21 items, each scored on a 4-point Likert scale (ranging from 0 to 3). A score above 13 points indicates the presence of clinical depression symptoms. BAI - It consists of 21 items, each scored on a 4-point Likert scale (ranging from 0 to 3). A score above 7 points indicates the presence of clinical anxiety symptoms.

  3. Catastrophism (PCS)

    Time frame: 12 months

    it measures feelings of helplessness, magnification, and rumination. It has 13 items, each reflecting different aspects of catastrophic thinking related to pain. Respondents rate each item on a 5-point Likert scale, ranging from 0 (not at all) to 4 (extremely), based on how frequently they experience the thought or feeling described. Higher scores indicate greater levels of pain catastrophizing.

  4. Psychopathology (MCMI-III)

    Time frame: 12 months

    It is a validated self-administered inventory with 175 true-false questions, assessing 14 personality disorder scales, divided into fourteen clinical patterns of personality based on Axis II disorders of DSM-IV, and ten clinical syndrome scales based on Axis I disorders of DSM-IV.

Study contacts

Contact information is provided by the study sponsor or research team.

Alessandra Telesca, phd

CONTACT

[email protected]

Licia Grazzi, MD

CONTACT

[email protected]

+ 39 02.2394

Sponsors and collaborators

Lead sponsor

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Other

Registry information

Official study title

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

Acronym: FACE-PRT

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Aug 14, 2025
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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