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New treatment option for Chronic Primary Orofacial Pain (CPOP)
Official title An Innovative Cognitive-Behavioral Treatment For Chronic Orofacial Pain
ClinicalTrials.gov ID: NCT07123233
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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...
- Written informed consent.
- Age 18 years or older.
You likely can't join if
- 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.
See the full eligibility 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 from previous chronic pain studies.
- Written informed consent.
- Age 18 years or older.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Milan, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Milan, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.