An Innovative Cognitive-Behavioral Treatment For Chronic Orofacial Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorFondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Pain Reprocessing Therapy
BehavioralOne 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. Use this module to add a description of each group or cohort in the study and to list any interventions of interest.
Usual Therapy
BehavioralPatients undergo yhe usual pharmacological tretment as prescrived by neurologist
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: PRT-TAUExperimental treatment 1 intervention
Group B: TAUPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Average pain intensity over the past week.
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).
Time frame
12 monthsSecondary outcomes
1
Quality of life (EUROHIS-8)
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.
Time frame
12 months2
Depressive and anxiety symptoms (BDI-II, BAI)
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.
Time frame
12 months3
Catastrophism (PCS)
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.
Time frame
12 months4
Psychopathology (MCMI-III)
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.
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov