Registro Italiano Dei Pazienti Affetti da Dolore Cronico
Conditions: Chronic Pain
Sponsor: Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva

 
Protocol version 02 del 9/10/2022 : “Registro Italiano Dei Pazienti Affetti da Dolore Cronico- REALIZER”  
 
 
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OBSERVATIONAL STUDY PROTOCOL  
Version 02 of 9.10.2022  
TITLE OF THE STUDY  
Italian Registry of Patients Suffering from Chronic Pain  
ACRONYM OF THE STUDY: 
REALIZER (Italian Registry of Chronic Pain Patients)  
 
 
 
PROMOTER: SIAARTI  
Coordinating Centre: IRCCS Maugeri Pavia 

 
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Introduction 
This protocol defines the role and type of database that is intended to be established by 
SIAARTI. 
This registry involves the prospective collection of data from subjects suffering from Chronic 
Pain of any origin. 
Participation in the study requires each subject to sign an informed consent form. 
In this protocol the terms Registry and Database will be considered synonymous. 
In this project there will be 3 phases: 
PHASE 1 
Pilot project (3 months): Participation of 7 centers proposing the project. Objective: structuring 
of the dataset and data entry methods. Dissemination of the project. 
PHASE 2 
Project extended to centers that wish to collaborate (24 months): Centers participate on a 
voluntary basis and are distributed evenly across Italy. Objective: full operation of the register to 
meet the objectives of the project.  
FASE 3  
SIAARTI promotes the register at the institutions for the establishment of a national register 
compliant with the DECREE OF THE PRESIDENT OF THE COUNCIL OF MINISTERS 
March  3rd, 2017 “Identificazione dei sistemi di sorveglianza e dei registri di mortalita', di tumori 
e di altre patologie. (17A03142) (GU Serie Generale n.109 del 12-05-2017)”  
 
 
 

 
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Table of Contents 
1. RATIONALE TO SUPPORT THE ESTABLISHMENT OF THE  DATABASE..............................................................5 
Description of the purposes of the database ………………………………......….......................................................................6 
2.OBJECTIVES........................................................................................................................................................................7 
Primary Outcomes.....................................................................................................................................................................7 
Secondary Outcomes.................................................................................................................................................................7 
3. STUDY DESIGN…………..................................................................................................................................................7 
Setting ..................................................................................................................................................................................... 8 
Participating Center.................................................................................................................................................................8 
Deviations from protocol….......................................................................................................................................................9 
Criteria for abandoning the ongoing study..............................................................................................................................9 
Ending the Study……................................................................................................................................................................9 
4. STUDY POPULATION…...................................................................................................................................................9 
Inclusion Criteria ….................................................................................................................................................................9 
Exclusion Criteria.....................................................................................................................................................................9 
Description of the pathologies being studied............................................................................................................................9 
5. PROCEDURES EXPECTED AND INFORMATION COLLECTED................................................................................9  
Enrollment procedure...............................................................................................................................................................9 
Follow-up procedure..............................................................................................................................................................10 
Data collection........................................................................................................................................................................10 
Data collection methods and anonymization..........................................................................................................................12 
Data management and storage……........................................................................................................................................13 
Data ownership.......................................................................................................................................................................13 
Subsequent use of the data......................................................................................................................................................13 
Archiving.................................................................................................................................................................................13 
6. ENDPOINT ........................................................................................................................................................................13 
Primary Endpoint....................................................................................................................................................................13   
Secondary Endpoint................................................................................................................................................................14 
7. INFORMED CONSENT……............................................................................................................................................14 
8. STATISTICAL ANALYSIS..............................................................................................................................................15 
Sample size..............................................................................................................................................................................15 
9. DATA MANAGEMENT AND PROCEDURE TO GUARANTEE PATIENT DATA CONFIDENTIALITY………...15         
10. SECURITY AND ADVERSE EVENTS..........................................................................................................................15  
11. ADMINISTRATIVE/REGULATORY CONSIDERATIONS .......................................................................................16 
Economic considerations .......................................................................................................................................................16 
Insurance considerations .......................................................................................................................................................16 
12. ETHICAL CONSIDERATIONS ....................................................................................................................................16 
Ethics ......................................................................................................................................................................................16  
ATTACHMENT 1..................................................................................................................................................................17  
DATA GATHERED FOR EACH PATIENT.........................................................................................................................17  
LEVEL 1: 
DEMOGRAPHICS.................................................................................................................................................................17 
LEVEL 2: 
DIAGNOSIS….......................................................................................................................................................................18 
TYPE OF PAIN……................................................................................................................................................................18 

 
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AREA OF PAIN.......................................................................................................................................................................19 
PAIN INTENSITY AND INTERFERENCE.............................................................................................................................19  
EXAMS REQUESTED ...........................................................................................................................................................20  
EXAMS COMPLETED .........................................................................................................................................................21 
LEVEL 3: 
THERAPY...............................................................................................................................................................................21 
PHARMALOGICAL THERAPY .............................................................................................................................................21 
INFILTRATIVE THERAPY ....................................................................................................................................................22 
NEUROMODULATORY/NEUROABLATIVE THERAPY .....................................................................................................22 
IMPLANTS/STIMULATORS.................................................................................................................................................. 22 
 
1. RATIONALE TO SUPPORT THE ESTABLISHMENT OF THE DATABASE 
The IASP (International Association for the Study of Pain) defines pain as an unpleasant sensory 
and emotional experience associated with actual or potential tissue damage or described in terms 
of such damage1. The physiological function of pain is to serve as a warning sign of a medical 
condition or injury. In these cases, treatment of the underlying medical condition is critical and 
can resolve the pain. However, pain may persist despite adequate management of the underlying 
condition, or the underlying medical condition may not be successfully treated. If the pain 
persists or recurs for more than three months, the pain is defined as chronic2,3. Long considered a 
non-life-threatening condition and often overlooked, persistent pain over time can actually 
become the sole or predominant clinical problem in some patients, generating a chronic 
condition that significantly impacts patients' quality of life through a wide range of negative 
physical, psychological and functional effects that limit social participation 4,5,6. For this reason, 
chronic pain is a condition that deserves a specific diagnostic evaluation and appropriate 
therapeutic efforts, integrated in a multidisciplinary context of physical and psychological 
rehabilitation. According to many authors, access to adequate pain care should be considered a 
human right7,8. Recent observations have highlighted a worrying prevalence of pain throughout 
the world, with significant variations between countries (ranging from 9, 9% to 50.3%)9. For this 
reason, and due to the impact that chronic pain has on healthcare spending, adequate pain control 
is considered a global health priority. In fact, chronic pain causes the greatest loss of productivity 
compared to any other health condition10 and constitutes a significant share of healthcare 
spending with costs reaching 3-10% of the gross domestic product of European countries11,12. 
An important milestone in the European health regulatory framework is represented by Law 
38/2010, which established the citizen's right to not suffer13. The law paved the way for 
recommendations to develop structures dedicated to palliative care and pain therapies and to 
organize hospital and outpatient facilities to guarantee diagnostic-therapeutic continuity for 
patients with chronic pain. Nonetheless, the provision of adequate care appears difficult to apply 

 
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in our country. Recent data puts Italy in third place in Europe in terms of prevalence of chronic 
pain (around 24%),14 and at least a third of patients suffering from it remain without a diagnosis 
or suffer a significant delay in referral to pain management clinics15,16,17. One of the reasons this 
happens could be found in the poor implementation of pain therapy networks in the various 
Italian regions caused by the lack of knowledge of the influx and need for pain therapy centers. 
For these essential resources to streamline clinical care pathways in the effort to manage chronic 
pain, it is necessary to understand the needs of the population. The epidemiological data 
available are mostly retrospective, collected on a regional basis and not across the entire 
territory, and are often incomplete or collected with methodological biases that do not make 
them usable for public health purposes. Furthermore, there is no clear clinical characterization of 
the patients who are referred to pain therapy centers to estimate the actual needs and 
effectiveness of the proposed treatments. In addition, there are no epidemiological data on the 
distribution of chronic pain and the association with potential risk factors in Italy, as there is no 
epidemiological register on the regional or national level.  
Clinical registries play an important role in monitoring diseases and healthcare delivery patterns. 
They represent the starting point for generating "real-world" evidence and for evaluating the 
impact of treatment and service delivery models on health outcomes. Registries are useful tools 
for directing projects to improve the quality of care to improve healthcare processes, adherence 
to guidelines and standards of care, and, ultimately, to optimize the costs of providing care. It has 
also been demonstrated that the establishment of clinical registries has a significant positive 
impact on outcome 18.  
This project aims to create an Italian registry of patients suffering from chronic pain with the aim 
of collecting clinical, epidemiological and outcome information on subjects belonging to pain 
therapy centers on a regional basis as part of the pain management assistance. 
Description of the purposes of the database  
The purposes for establishing this database are the following: 
• continuously and systematically collect, evaluate, and archive relevant demographic and 
clinical information on patients belonging to chronic pain treatment centers, making it available 
for studies and research. 
• promote the use of uniform and comparable classification systems, definitions, and records 
 in the structures participating in the database. 

 
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• Define the flow of patients referring to pain therapy centers to allow adequate 
health planning and the priority areas of intervention of the national health plan. 
 
 
 
 
 
The data collected will facilitate the planning of future studies aimed to: 
• define the impact of chronic pain at a local and national level, and its territorial and temporal 
variations over time, through prevalence and incidence measures; 
• identify clinical subtypes, risk factors, predisposing and triggering factors; 
• increase knowledge in the field of chronic pain to standardize diagnostic/therapeutic pathways 
and promote adequate management strategies. 
2. Objectives  
Primary Outcomes  
Identify the profiles of patients belonging to oain therapy centers in terms of: 
1. Location and type of pain 
2. Prescribed therapies 
3. Effectiveness of therapies 
4. Time needed to reach the efficacy outcome 
Secondary Outcome 
1. Evaluate the proportion of patients who reach the outcome of 30 or 50% improvement 
2. Evaluate the healthcare resources used in terms of number of visits and time needed to achieve 
the best outcome (30 or 50% improvement) 
3. Identify patient profiles that are related to clinically significant outcomes and the specific 
treatments performed, plus their intermediate surrogate outcomes in relation to specific patterns 

 
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4. 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.  
3. Study Design 
This is a prospective, multicenter, non-profit observational cohort study. No intervention on 
patients outside of common clinical practice is envisaged. 
The study is divided into three phases. 
Phase 1, expected to last three months, involves the participation of 7 centers proposing the 
project and aims to structure the dataset and data entry methods. Actions will also be 
implemented for dissemination of the project by trying to recruit centers distributed across the 
national territory. Estimated start date 01/03/2023. 
In phase 2, the project expands to the centers that wish to join, and this protocol will be fully 
operational. 
The duration of phase 2 is two years and six months, presumably starting from 01/06/2023. 
Patient enrollment at each center will begin at different times depending on the rollout of the 
registry and local ethics committee approval. It is likely that the first patient will be prospectively 
enrolled in 01/06/2023. The last patient will be enrolled by 01/03/2025 and it will be possible to 
enter data and follow-up until 01/09/2025. The results of this study will be available by 
01/12/2025. 
Once the patient has been enrolled, it will be possible to trace the patient's personal file and 
update it at each follow-up until the end of enrollment. 
In phase 3, SIAARTI will promote the register at the institutions for the establishment of a 
national register compliant with the DECREE OF THE PRESIDENT OF THE COUNCIL OF 
MINISTERS 3 March 2017 "Identification of surveillance systems and registers of mortality, 
tumors and other pathologies. (17A03142) (GU General Series n.109 of 12-05-2017)” 
Setting  
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. 

 
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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. 
The complete list of centers involved initially is reported on the title page of the protocol. 
  
Deviations from protocol 
Any deviations from this protocol will be reported to the local Ethics Committee (EC) by the 
Principal Investigator by sending a request to modify the protocol. This request will be examined 
by the CE according to local/internal regulations. 
 
Criteria for abandoning the ongoing study 
The patient can renounce participation in the study at any moment by withdrawing informed 
consent. The data collected may be kept if made completely anonymous  and if previously 
authorized by the patient. 
 
Ending the study 
In addition to reporting the start and end dates of the study for monitoring purposes, the Principal 
Investigator will inform the EC of an early termination of the study and the related reasons. 
 
4. 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. 
 
Inclusion criteria 
- Subjects > 4 years old 
- NRS > 4 
- Diagnosis of Chronic Pain according to the IASP19 criteria 
- Adherence through written informed consent to participate in the study 

 
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Exclusion criteria 
- 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 
 
Description of the pathologies being studied 
Adult patients will be enrolled, diagnosed with Chronic Pain (pain lasting > 12 weeks), 
regardless of the etiology, modality, and age of onset. 
5. PROCEDURES EXPECTED AND INFORMATION COLLECTED 
Enrollment procedure 
Adult patients of both sexes who belong to pain therapy centers with a diagnosis of Chronic 
Pain (pain that lasts > 12 weeks), regardless of the etiology, modality and age of onset, will be 
considered eligible for enrollment.  
It will be possible to enroll patients during their first visit (FIRST ANESTHESIOLOGICAL 
VISIT), or during a check-up visit (ANESTHESIOLOGICAL CHECK-UP VISIT) or during a 
scheduled hospitalization for pain procedures (ORDINARY OR DAY HOSPITAL 
ADMISSION) 
Patients will be asked to join the study after having been informed in detail (also with the aid of a 
written information form) of the objectives of the project, as well as the methods with which 
these objectives will be pursued. Participants will be informed about the lack of informative 
feedback regarding the results of future clinical evaluations: the results of any research 
originating from the register, in fact, will not be delivered to the participants themselves. The 
subject who freely accepts will authorize the inclusion of their data in the project by signing the 
informed consent form of which they will receive a copy. It will also be clearly explained in the 
information sheet attached to the informed consent that each participant will have the possibility 
of withdrawing their participation from the study at any time, without providing any reason and 
without this jeopardizing the doctor-patient relationship with the specialists involved in the 
project. 
Patients will be informed by the manager of the patient’s pain center or the principal investigator 
for the center (assuming this is not the same individual). 
The doctor will complete the electronic CRF after evaluating the patient and classifying him 
according to the criteria of the IASP (International Association for the Study of Pain) in terms of 
primary or secondary chronic pain. In the case of a patient enrolled during a check-up or during 
hospitalization, all data relating to the time in which the patient is in care at the center, the 

 
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invasive procedures previously undertaken, the drugs prescribed, will be collected. Retrospective 
data (only for patients already being treated at the center) will be collected according to a 
predefined group (e.g.: the patient has been in the care of the center for: > 5 years; from 1 to 5 
years; from 1 year to 6 months; from 3 to 6 months; < 3 months). 
Follow-up procedure 
Once enrolled, the patient will be followed prospectively until the end of enrollment. At each 
visit it will be possible to retrieve the patient's chart and fill in the data relating to the intensity of 
pain and the treatments undertaken. It will also be possible to modify or add an etiological 
diagnosis in forms of secondary chronic pain. There is no limit to the number of follow-ups for 
each patient as long as the database is active (3 months from the date of enrollment of the last 
patient, considering a 12-month active enrollment expected for this study). 
Data gathered 
The activities of the registry do not replace routine diagnostic tests or visits to your doctor. The 
data collected by the registry will include relevant demographic data of the patient, 
comorbidities, the duration of the pain (> 5 years; from 1 to 5 years; from 1 year to 6 months; 
from 3 to 6 months), the type of pain, the location of the pain, the intensity of the pain (Brief 
Pain Inventory- Severity (BPI-S) and pain interference in daily activities (Brief Pain Inventory- 
Interference (BPI-I), treatments received (categorized according to pharmacological therapy, 
infiltrative therapy, ablative or neuromodulatory therapy, implants), the tests conducted, the 
number of other medical specialists contacted for the pathology being studied, the professional 
who sent it to the center. Specifically, the data collected is shown in Attachment 1 
In particular, patients will be characterized by: 
Type of pain (chronic primary or chronic secondary according to the scheme proposed by IASP) 

 
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Location of pain according to the following scheme (multiple options are possible) 
Lower back pain 
Thoracic 
Upper arts 
Lower limbs 
Head/Neck 
Pelvis 
 
Pain Intensity 
Brief Pain Inventory-Severity (BPI-S)  
 
Interference with daily activities 
Brief Pain Inventory-Interference (BPI-I)  
Clinical information related to the pathology 

 
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Therapy 
Pharmacological 
Infiltrative  
Implantable  
 
Data collection methods and anonymization  
 
The data collected will be used for scientific and epidemiological purposes. Each data will be 
created by a participating center and recorded on the SIAARTI Servers via a web application 
using the RedCap® data management software. 
  
The study data will be collected and managed using the REDCap20,21 electronic data acquisition 
tools made available by SIAARTI. REDCap (Research Electronic Data Capture) is a secure, 
web-based software platform designed to support data capture for research studies. It provides: 
1) an intuitive interface for acquiring validated data; 
2) Controlled channels with customized access privileges for monitoring data manipulation and 
export procedures; 
3) automated export procedures for continuous data download to common packages 
of statistical software; 
4) procedures for data integration and interoperability with external sources. 
 
Data will be recorded in the e-CRF only after being anonymized using coding procedures 
described in a separate document, in accordance with applicable data protection laws, including 
the EU GDPR. The encryption key of the anonymous data which contains the patient's name, 
surname and date of birth will be archived only in the files of the local site in a register that 
allows registration and research of the subject. 
For each center participating in the project, an account will be created on the REDCap platform. 
The data will be recorded using an encrypted data connection (HTTPS) of anonymized input via 
a web browser or mobile app. 
To enable data analysis, each patient will be assigned a unique Subject ID (Patient Identification 
Number). 
REDCap is a secure web application for creating and managing online databases. Unauthorized 
access to data is impossible since access is permitted according to a hierarchical and role-based 
criterion. Access to REDCap will be allowed only to data collection personnel of the 
participating centers, according to the methods established by this protocol. These people will 
keep the information private. 
 

 
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Data management and storage  
RedCap management software will be used for data management. The identification of 
individual patients by name will not be necessary or required at any time. During the collection 
and processing of data, therefore, all necessary measures will be adopted to effectively establish 
anonymization. SIAARTI will also take care of data storage. Each participating center can only 
access the patient data it has generated and registered on the REDCap platform. Each 
participating center is required to provide periodic ad hoc reports on the data collected. 
Data ownership 
Individual data provided by a participating center are primarily the property of the center that 
generated the data. All investigators have the right to access their data at any time. SIAARTI will 
be co-owner of the data, in agreement with each participating center. 
Subsequent use of the data  
SIAARTI and the executive committee, on behalf of the investigators, have the right to use all 
data collected in the database for scientific purposes. The executive committee and the SIAARTI 
study groups have the right to access the data in the registry, for research purposes after the 
conclusion of the research project, and with the approval of the SIAARTI Scientific Committee. 
In any case, the researchers who contributed to the project will be regularly informed about the 
ongoing study activities and will be given the opportunity to be included among the authors of 
any publications. 
Storage 
A copy of the electronic database will be kept at the SIAARTI headquarters and kept for 5 years 
for subsequent use by SIAARTI and the executive committee. 
6. ENDPOINT  
Primary Endpoint  
The number of patients referring to the centers, the type of pain, the proportion of patients who 
reach the clinically significant outcome, the type of therapies prescribed (pharmacological, 
neuromodulatory or implanted) necessary to achieve the outcome and the number of accesses 
and the Time in which a clinically significant improvement will be achieved (Change in BPI-s or 
BPI-I; a reduction of > 30% is considered clinically significant and a reduction of > 50% is 
considered optimal, the data will be evaluated for each Item). 

 
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Secondary Endpoint  
1. The effectiveness of the treatments will be described in terms of 
a. Change in pain intensity according to the Brief Pain Inventory-Severity 
questionnaire (BPI-S) A reduction of > 30% is considered clinically significant 
and optimal a reduction > of 50% the data will be evaluated for each Item) 
b. b. Change in pain interference on daily activities according to the Brief Pain 
Inventory-Interference questionnaire (BPI-I). A reduction of > 30% is considered 
clinically significant and a reduction of > 50% is considered optimal; the data will 
be evaluated for each item) 
2. Proportion of patients achieving clinically significant outcomes in relation to baseline 
characteristics and specific treatments performed and their intermediate surrogate 
outcomes in relation to specific patterns. 
3. Resources used: Number of visits to the center for each patient in a year; Number of 
ordinary or day hospitalizations for each patient in a year. 
4. The clinical variables relevant to the outcome will be described (e.g. type of pain, 
comorbidities, the time between treatment and clinically significant improvement, type of 
therapy undertaken - pharmacological, invasive, implant-based) 
 
7. INFORMED CONSENT  
Patients enrolled in the study will be given a complete and exhaustive explanation about the 
nature, purposes, possible risks, and benefits of the study. The patient will be informed that 
he/she will be free to stop the study at any time. The patient will be given the opportunity to ask 
questions and will be given as much time as desired to evaluate the information provided. For the 
pediatric population, consent will be requested from parents in the same way. 
The investigating doctor will keep the original of the signed written informed consent. 
In the written informed consent form it will be specified that the study data will be stored in 
computerized form and that the confidentiality of the data itself will be maintained in accordance 
with the provisions of current legislation. 
 

 
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8. STATISTICAL ANALYSIS 
All enrolled patients registered in the registry will be included in the analyses. A descriptive 
analysis will be performed on the collected data. In general, qualitative variables will be 
described using frequency distributions; the quantitative variables will be described by mean and 
standard deviation if normally distributed, and by median and interquartile range if 
asymmetrically distributed. As appropriate, statistical tests will be used for exploratory purposes. 
Treatment effects (Change in BPI-S and BPI-I scores) will be calculated as the ratio of the 
difference between baseline and follow-up scores to the baseline score. If the data allow it, 
inferential analysis will be applied on quantitative data (such as: comparison of Student's t 
means, Fisher's F, etc.), or on qualitative data (such as: chi square, odds ratio, Mann Whitney U, 
etc.). The prevalence of the different pathologies and the related confidence intervals will be 
estimated. Detailed statistical analysis plans will be set up in future research protocols that will 
use this database as a source of data. 
Sample Size  
Since this is an observational registry, no prior sample size calculation is required. Considering 
an expected participation of 12 centers, an estimate of 2500 patients included appears reasonable. 
9. DATA MANAGEMENT AND PROCEDURE TO GUARANTEE PATIENT DATA 
CONFIDENTIALITY  
The individual pain centers, which are the sources of the data, are responsible for detecting, 
enrolling, coding and recording cases and are functionally linked to the primary center from 
which they draw methodological indications of an operational nature. Sensitive data will be 
noted, anonymized through an encryption procedure, and stored in a secure place. 
10. SECURITY AND ADVERSE EVENTS 
This observational study will be conducted according to the current protocol. This is a non-
interventional observational study. Any study based on this registry will not receive any 
guidance on the treatment of patients. Complications and adverse events that occur during 
follow-ups will be recorded in the registry. 

 
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11. ADMINISTRATIVE/REGULATORY CONSIDERATIONS 
Economic considerations  
No additional costs will be charged to the Healthcare System. 
Insurance considerations  
Given the observational nature of the study and which involves recording what happens in 
common clinical practice without deviations from the standard of care in each participating 
center, an additional insurance policy to that already provided for normal clinical practice is not 
necessary. 
12. ETHICAL CONSIDERATIONS 
This observational study is designed and will be conducted according to the current protocol, in 
accordance with EU Directive 2001/20/EC relating to the implementation of the principles of 
good clinical practice in the conduct of clinical trials on medicinal products for human use, in 
accordance with the principles published in Good Clinical Practice (GCP) guidelines and in 
accordance with the Declaration of Helsinki on Ethical Principles for Medical Research 
Involving Human Subjects, adopted by the General Assembly of the World Medical Association 
(1996), 
The investigator guarantees that personal patient data will be protected and processed in 
accordance with the General Data Protection Regulation (EU) 2016/679 (GDPR) on data 
protection and privacy. 
 
 
 
 
 

 
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ATTACHMENT 1 
DATA GATHERED FOR EACH PATIENT 
 CENTER CODE 
 UNIQUE PATIENT CODE 
 ACCESS METHOD (TO BE COMPLETED ONLY THE FIRST TIME FOR EACH 
PATIENT 
 DATE (the CRF must be filled in each time the patient has a visit/admission)  
 SENT BY: 
• FAMILY DOCTOR 
• OTHER SPECIALIST 
• ADVICE FROM A RELATIVE/ACQUAINTANCE  
• WEB SEARCH 
 REFFERAL METHOD (TO BE COMPLETED ONLY THE FIRST TIME FOR EACH 
PATIENT) 
 FIRST ANESTHESIOLOGICAL VISIT 
 ANESTHESIOLOGICAL CHECK-UP EXAMINATION 
o UNDER CARE AT THE CENTER FOR:  
▪  > 5 years; 
▪ from 1 to 5 years; 
▪ from 1 year to 6 months; or 3 to 6 months; 
▪ < 3 months 
 ORDINARY HOSPITALIZATION 
o IN EMPLOYMENT AT THE CENTER FOR: o > 5 years; 
▪ from 1 to 5 years; 
▪ from 1 year to 6 months; or 3 to 6 months; 
▪ < 3 months 
 DAY HOSPITALITY (DAY SURGERY OR DAY HOSPITAL) 
o IN EMPLOYMENT AT THE CENTER FOR:  
▪ > 5 years; 
▪ da 1 a 5 anni; 
▪ da 1 anno a 6 mesi; o da 3 a 6 mesi; 
▪ < 3 mesi  
LEVEL 1: DEMOGRAPHICS  
 

 
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 AGE ........  
 SEX 
o M 
o F 
 
STATE/COUNTY OF RESIDENCE 
SCHOOL LEVEL  
 Not Known 
 Grade School  
 High School 
 University  
WORK 
 WORKER 
 UNEMPLOYED 
COMORBIDITIES 
 CARDIOVASCULAR 
 DIABETES 
 RESPIRATORY 
 AUTOIMMUNITY 
 CHRONIC INFLAMMATION 
 OTHER 
LEVEL 2: DIAGNOSIS  
TYPE OF PAIN  
 PRIMARY CHRONIC  
o CHRONIC WIDESPREAD PAIN 
▪ FIBROMYALGIA 
▪ OTHER 
o CRPS 

 
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o HEADACHE OR OROFACIAL PAIN 
o MUSCULOSKELATAL  
▪ LOW-BACK PAIN 
▪ ALTRO  
 SECONDARY CHRONIC 
o ONCOLOGICAL 
o POSTSURGICAL 
▪ LUMBAR 
▪ CERVICAL 
▪ BREAST 
▪ INGUINAL HERNIA 
▪ THORACOTOMY 
▪ OTHER 
o POST TRAUMATIC 
▪ CRPS  
▪ OTHER 
o NEUROPATHIC  
▪ PERIFERAL 
▪ POST-TRAUMATIC  
▪ DIABETIC 
▪ TRIGEMINAL 
▪  POST-HERPETIC 
▪ OTHER 
o CENTRAL 
▪ POST-ISCHEMIC 
▪ SM 
▪ TRIGEMINAL 
▪ NEURODEGENERATIVE DISEASES 
o HEADACHE OR OROFACIAL PAIN 
o VISCERAL 
o SKELETAL MUSCLE 
▪ LOW-BACK-PAIN  
▪ OTHER 
 
AREA OF PAIN 
 LOWER BACK PAIN 

 
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 THORACIC 
 UPPER LIMBS 
 LOWER LIMBS 
 HEAD/NECK 
 PELVIS 
PAIN INTENSITY AND INTERFERENCE 
 BPI-S 
 
WORST PAIN IN THE LAST 24 HOURS 
• 1 • 2 • 3 • 4 • 5 • 6 • 7 • 8 • 9 • 10 
LEAST PAIN IN THE LAST 24 HOURS 
• 1 • 2 • 3 • 4 • 5 • 6 • 7 • 8 • 9 • 10 
AVERAGE PAIN IN THE LAST 24 HOURS 
• 1 • 2 • 3 • 4 • 5 • 6 • 7 • 8 • 9 • 10 
CURRENT PAIN  
• 1 • 2 • 3 • 4 • 5 • 6 • 7 • 8 • 9 • 10 
HOW MUCH RELIEF HAVE YOU HAD FROM THE THERAPY (%) 
• 10• 20• 30• 40• 50• 60• 70• 80• 90• 100 
 
BPI-I (PAIN INTERFERENCE ON)  
 
ACTIVITY IN GENERAL 
• 0•1•2•3•4•5•6•7•8•9•10 
MOOD 
• 1 • 2 • 3 • 4 • 5 • 6 • 7 • 8 • 9 • 10 
ABILITY TO WALK 
• 1 • 2 • 3 • 4 • 5 • 6 • 7 • 8 • 9 • 10 
NORMAL WORKING ABILITY (both at home and outside)  
• 1 • 2 • 3 • 4 • 5 • 6 • 7 • 8 • 9 • 10 
RELATIONSHIPS WITH OTHER PEOPLE 
• 1 • 2 • 3 • 4 • 5 • 6 • 7 • 8 • 9 • 10 
 SLEEP 
• 1 • 2 • 3 • 4 • 5 • 6 • 7 • 8 • 9 • 10 

 
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PLEASURE OF LIVING 
• 1 • 2 • 3 • 4 • 5 • 6 • 7 • 8 • 9 • 10 • 1 • 2 • 3 • 4 • 5 • 6 • 7 • 8 • 9 • 10  
REQUESTED EXAMS 
 
INSTRUMENTAL EXAMS 
o XRAY 
o MRI 
o SCINTIGRAPHY 
o EMG/ENG 
o OTHER 
 
LABORATORY EXAMS 
 
COMPLETED EXAMS 
• CLINICAL EXAMINATION OF SENSITIVITY 
• QST-TEST 
• DIAGNOSTIC BLOCK 
 
LEVEL 3: THERAPY  
PHARMACOLOGICAL THERAPY  
 SNRI 
 GABAPENTINOIDS  
 TRICICLICS 
 OPIOIDS 
o TRAMADOL 
o CODEINE/PARACETAMOL 
o OXYCODONE/PARACETAMOL 
o MORPHINE SR 
o MORPHINE IR 
o OXYCODONE 
o OXYCODONE/NALOXONE 
o HYDROMORPHONE 
o TAPENTADOL 
o TRANSDERMAL FENTANYL 
o TRANSMUCOSAL FENTANYL 
o BUPRENORPHINE 
o METHADONE 

 
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 NSAIDs 
o AS NEEDED 
o INTERVALS/REGULARLY (indicate how many days) 
 COXIB 
o AS NEEDED 
o INTERVALS/REGULARLY (indicate how many days) 
 PARACETAMOL 
 OTHER 
 
 
INFILTRATIVE THERAPY  
 EPIDURAL 
 INTRA-ARTICOLAR (SHOULDER, KNEE, ANKLE, HIP, ECC) 
 SPINAL FACET JOINTS 
 SACRO-ILIAC 
 PERIPHERAL NERVE 
NEUROMODULATORY/NEUROABLATIVE THERAPY  
 GANGLIAR RADIOFREQUENCY 
 RADIOFREQUENZY OF PERIPHERAL NERVES  
 CRIOAMODULATION 
 EPIDUROLYSIS 
 EPIDUROSCOPY  
IMPLANTS  
 SCS NON-RECHARGABLE 
o CERVICAL 
o DORSAL 
 SCS RECHARGABLE 
o CERVICAL 
o DORSAL 
 STIMULATION OF PERIPHERAL NERVE 
 GANGLIAR STIMULATION 
 INTRATHECAL PUMP 

 
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PRG, Pain Researchers Group into Latium Region, Diamanti P, Coaccioli S, Tarsitani G, Cattaruzza MS. Epidemiology 
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