Registro Italiano Dei Pazienti Affetti da Dolore Cronico
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2,500
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
The study aims to collect demographic and clinical data from patients belonging to pain therapy centers recognized at the regional level and belonging to the pain therapy networks established incompliance with law 38/2010 and according to the Agreement between the Government and the Regions of 25 July 2012.
Patients will be registered regardless of the access modality (outpatient or hospitalization) and will be characterized by pathology and treatments performed. The participation of centers for the treatment of pediatric pain is expected. Data relating to patients under the age of 18 will be analyzed separately.
The database aims to follow the patients enrolled according to a code that makes them anonymous.
Participating Centers The dissemination phase constitutes an integral part of the study and is not possible to predict the definitive number of centers involved. Key professionals have been contacted who will be responsible for the dissemination and implementation of this study based on each center's records. The ethics committee of the coordinating center will be regularly updated by the Principal Investigator as new centers join the study.
STUDY POPULATION The Registry data will be collected by the structures involved in the management of patients suffering from chronic pain, regardless of the cause. It is necessary to keep the inclusion criteria as broad as possible to obtain a real picture of clinical practice at a national level.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 4 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
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
时间窗: one year
Description of treatments offered to each patient
Characterization of the profile of patients admitted to pain clinics in Italy: number of patients admitted
时间窗: one year
Progressive count
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
时间窗: one year
The Brief Pain Inventory questionnaire will be used to assess efficacy of treatmens. 30% of reduction will be considered clinically relevant
Characterization of the profile of patients admitted to pain clinics in Italy: type of pain.
时间窗: one year
A semplified ICD-11 Classification will be used
Characterization of the profile of patients admitted to pain clinics in Italy: time in which a clinically significant improvement will be achieved
时间窗: one year
Number of days needed to reach a clinically relevant outcome
次要结局
- Resources employed for each patient(one year)
- Proportion of patients who reach an optimal improvemnet(one year)
研究者
Silvia Natoli
Principal Investigator
Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva