Registro Italiano Dei Pazienti Affetti da Dolore Cronico

NCT06228300 | Not Yet Recruiting

• 1 other identifier: REALIZER
• Study Type: observational
• Target: 2,500
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this Multicenter, non-profit, noninterventional, prospective observational cohort study is to create a register of patients suffering from Chronic Pain of any origin in subject with diagnosis of Chronic Pain according to the IASP19 criteria (Subjects \> 4 years old - NRS \> 4) The main question\[s\] it aims to answer are: Identify the profiles of patients belonging to pain therapy centers Evaluate the proportion of patients who reach the outcome of 30 or 50% improvement Evaluate the healthcare resources used in terms of number of accesses and time needed to achieve the best outcome (30 or 50% improvement) Identify patient profiles in terms of clinically significant outcomes in relation to baseline characteristics and specific treatments performed and their intermediate surrogate outcomes in relation to specific patterns Describe the relevant clinical variables in the study population. In particular, the absolute and relative frequencies of those clinical variables relevant to the effectiveness of the treatment will be described, categorized by type of treatment, and the timing of the start of treatment with respect to the onset of pain. The data collected may be used for predictive analyses Participants with a diagnosis of chronic pain (pain lasting \> 12 weeks) will be enrolled, regardless of the etiology, modality and age of onset.

Conditions

Chronic Pain

Keywords

Chronic Pain; Invasive pain management; Medical Pain Managemnet

Outcome Measures

Primary Outcomes (5)

• Characterization of the profile of patients admitted to pain clinics in Italy: number of patients admitted

  Progressive count

  one year

• Characterization of the profile of patients admitted to pain clinics in Italy: type of pain.

  A semplified ICD-11 Classification will be used

  one year

• Characterization of the profile of patients admitted to pain clinics in Italy: proportion of patients who reach a clinically significant outcome. ; time in which a clinically significant improvement will be achieved

  The Brief Pain Inventory questionnaire will be used to assess efficacy of treatmens. 30% of reduction will be considered clinically relevant

  one year

• Characterization of the profile of patients admitted to pain clinics in Italy: type of prescribed therapies (pharmacological, neuromodulatory or implant) necessary to achieve a clinically significant improvement

  Description of treatments offered to each patient

  one year

• Characterization of the profile of patients admitted to pain clinics in Italy: time in which a clinically significant improvement will be achieved

  Number of days needed to reach a clinically relevant outcome

  one year

Secondary Outcomes (2)

• Resources employed for each patient

  one year

• Proportion of patients who reach an optimal improvemnet

  one year

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients suffering from chronic pain

You may qualify if:

• Subjects \> 4 years old
• NRS \> 4 - Diagnosis of Chronic Pain according to the IASP19 criteria
• Accession through written informed consent to participate in the study

You may not qualify if:

• Patients suffering from psychiatric pathology or severe cognitive impairment for which the enrolling doctor does not believe it is useful for the purposes of the study;
• Patients unable to sign the informed consent.

Sponsors & Collaborators

• Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva: lead

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 18, 2024
• First Posted: January 29, 2024
• Study Start: February 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: April 1, 2026
• Last Updated: January 31, 2024

Record last verified: 2024-01