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Pathos 2016; 23; 3. Online 2017, Jan 12
Evolution in clinical and demographic characteristics
of chronic pain patients affering to a Second Level Pain Unit
Evoluzione delle caratteristiche cliniche e demografiche
dei pazienti con dolore cronico
afferenti a un Servizio di Terapia del Dolore di Secondo Livello
_______________________________________________________
Laura Demartini,1 Luciana Armiento,1 Lucia Aurini,2
Alessandra Maria Spinelli,2 Lucia Angelini,1
Gianluca Conversa,1 Rita Melotti,2 Cesare Bonezzi1
1 Pain Unit, ICS Maugeri, Pavia, Italy
2 Anesthesia Department, University of Bologna, Italy
_______________________________________________________
Summary  Chronic pain is a common condition related to many diseases. In Italy, as in the rest of Europe, about 20 percent of adults report moderate to severe chronic pain, but very few patients refer to pain specialists and nearly half receive inadequate pain management. This leads to low health-related quality of life and psychological problems with costly issues in the Italian Health Care system. Epidemiologic studies, through an understanding of chronic pain characteristics, report the development, targeting and evaluation of interventions. In this retrospective observational study we analyzed the clinical and demographic data of a population referred for the first time, in 2014, to a specialist, in the second level Pain Unit, Fondazione Salvatore Maugeri, Pavia.
The aim was also to evaluate the improvement of pain management in our country after the approval of Law 38/2010 on the institution of the network for Palliative care, comparing the results with a previous similar survey in 2008.
We conclude that in Italy patients refer to a Pain clinic very late which causes an increase in the duration of pain and the risk of overlapping factors toward chronicity, even though we noted an improvement compared to 2008.
Riassunto  Il dolore cronico è una condizione comune correlate a molte malattie. In Italia, come nel resto d’Europa, circa il 20 per cento degli adulti lamenta un dolore da moderato a severo, ma solo pochi pazienti si rivolgono a uno specialista algologo e circa la metà di questi riceve cure inadeguate. Questo conduce a una minore qualità di vita con ripercussioni psicologiche e problemi economici nel SSN. Studi epidemiologici, attraverso la comprensione del dolore cronico, riportano lo sviluppo e la valutazione degli interventi.
In questo studio retrospettivo osservazionale abbiamo analizzato i dati clinici e demografici di una popolazione che afferiva per la prima volta, nel 2014, a uno specialista presso il Servizio di Terapia del Dolore di secondo livello della Fondazione Salvatore Maugeri di Pavia.
Lo scopo inoltre è stato valutare il miglioramento della gestione del dolore nel nostro Paese dopo la legge 38 – Marzo 2010, confrontando i risultati con una precedente indagine del 2008.
In Italia i pazienti afferiscono a un Servizio di Terapia del Dolore molto tardi, con un aumento della durata del dolore e il rischio che si sovrappongano altri fattori verso la cronicizzazione. Nonostante ciò, abbiamo notato un miglioramento rispetto al 2008.
Keywords chronic pain, epidemiology
Parole chiave epidemiologia dolore cronico

Introduction
Aging of the global population has been accompanied by a rising prevalence of chronic and degenerative diseases1 and, consequently, a higher incidence of pain and disability2-3. Good epidemiological research on chronic pain provides important information on prevalence and factors associated with its onset and persistence4. Epidemiology is the ”study of distribution and determinants of health-related states or events in specified population and the applications of this study to control health problems5.
Chronic pain of moderate to severe intensity occurs in 19 percent of adult Europeans, seriously affecting the quality of their social and working live6.  AISD (Italian Association for the Study of Pain) and GfK Eurisko in 2007 made a study about ”chronic pain in the Italian population” on a sample of 15,000 patients that was representative of the Italian adult population, by geographical area, gender and age (older than 18). The report revealed that over 20% of the respondents suffered from chronic non-cancer pain. Among them, about 4 percent (2 million Italians) suffered from neuropathic pain with severe impact on the quality of life.
The absence of sufficient knowledge and attention to pain by health professionals led to the increase of its prevalence7-10. In Italy, both general practitioners/family doctors (GPs) and patients are often unaware of dedicated pain services. Very few people were assisted by pain specialists and nearly half received inadequate pain management6; fewer than 2% of sufferers received pain care and were managed mainly in primary care setting, if anywhere11. When the patient is finally referred to a pain specialist, it is usually too late to prevent pain sensitization and the so-called pain syndromes. Data reported that the delay of pain treatment is associated with deterioration in health-related and psychological quality of life12. Untreated pain may become very costly in the Health Care System of any country13 in terms of both use of analgesic strategies and loss of working days. These data demonstrate that pain remains an important clinical problem not only for the inpatients14-15 but also for the patients at home, where the problem of failing pain management is accompanied by uncontrolled use of drugs16.
We studied the clinical and demographic characteristics of patients referred to the Pain Unit at the Fondazione Salvatore Maugeri, Pavia, in 2014, in order to compare the data with the ones obtained in a similar study in 2008 to investigate the differences in the pain population and pain management over the last 6 years, if any occurred.

Methods
The aim of this retrospective observational study was to analyze the population who came to the Pain Unit of Fondazione Salvatore Maugeri, Pavia, from January to December 2014 and to compare this sample with the previous analysis made in 2008 at the same Pain Unit. We considered the same criteria applied to the sample evaluated in 2008: patients suffering from non-cancer chronic pain, coming for the first time at our Unit were asked to fill-up a self-assessment questionnaire. We collected information about: demographic data (sex, age and geographical origin), pain areas, time passed between the pain onset and the first visit at the Unit, pain intensity (as measured with the Numerical Rating Scale, NRS and with the Verbal Rating Scale, VRS), previous pharmacological treatments (Non-Steroidal Anti-Inflammatory Drugs- NSAIDs), acetaminophen, weak opioids, strong opioids, benzodiazepines, anticonvulsants, antidepressants, steroids, muscle relaxant drugs) and interventional treatments (injections, massages, anesthetic blocks, physical therapies, acupuncture), who referred the patients to our Pain Unit (GP, specialists, other hospitals, friends, relatives, other pain specialists, media).
 
Statistical analysis
All data were analyzed by a medical doctor, who was not involved in routine clinical practice and blinded to the diagnosis. The results are expressed as means and standard deviations (SD) and range for quantitative variables and as percentages in qualitative variables.
In some categories, the sum of the percentages is not 100 percent because patients could indicate more than one data.
 
Results
In 2014, 353  patients out of the 1127 visited for the first time in Maugeri Pain Unit, filled a pain questionnaire (some patients did not receive it and others did not fill it for different reasons) compared to 234 patients evaluated at the same Unit in 2008.  
The sample included 233 (66%) females and 120 (34%) males, the mean age was 63.6 years (± 16), 62.4 (± 16.8) for males and 64.2 (± 15.6) for females (range 22-100 years) (Table 1). The sample resulted very similar to the one evaluated in 2008 (Figure 1).
More in details, only 107 patients (30.3%) completed the questionnaire in each part, the remaining  246 patients missed to report data about pain duration (9 patients), who referred him/her to the Pain Unit (50 patient), NRS (70 patients), VRS (57 patients), painful areas (14 patients),  previous pharmacological treatments (56 patients) and previous interventional treatments (166 patients). These data demonstrate a major compliance to answer the questionnaire compared to the population of 2008.
The time lapse between pain onset and the visit at our Pain Unit was mean 53 months with a range of 1-360 months. Women get to the pain center after 64 months from the pain onset while men came much earlier, after 31 months.
259 patients admitted at the Maugeri Pain Unit lived in Pavia or province (73.4%), 63 (17.8%) came from Lombardia (the region where the Pain Unit is located), 31 patients (8.8%) came from the rest of Italy (Figure 2); these data reveal a different sample from the previous one where almost 35% of the patients came from farther places.
 
The person who referred the patients of the Pain Center was mainly the GP (160 patients, 45.3%), showing an increase compared to 2008 (35.5%); 105 patients (29,5%) were referred by other specialists, (orthopedics, neurologists, physiatrists, 2.3 % were pain specialists); 7 patients (2%) were informed through media and the other 31 patients (8.8%) by relatives and friends (Figure 3).
The body areas where patients reported their pain were divided into four groups: spine, upper limbs, lower limbs and other (head, eyes, neck, mouth, hip, etc.). We found that 183 patients (51.8%) reported their pain in the spine, 63 (17.8%) in upper limbs, 166 (47%) in lower limbs, 54 (15.3%) in other regions and 16 patients (4.5%) reported generalized pain all over the body. Furthermore 204 patients (57.8%) referred  their pain in a single area, 95 (26.9%) patients in two areas and 24 (6.8%) in three areas. These data are similar to the ones collected in 2008.
The mean NRS was 6.7 (±2.6 SD), range 0-10 with no significant differences between genders. We identified different pattern depending on the age group, with the highest NRS in the population aging 61-80 years (Figure 4). The patients were asked to report their pain also with the VRS (Verbal Rating Score) and 83.7 percent answered as follow: 3.9% very mild, 5.3% mild, 24.9% moderate, 35.8% strong, 12.9% very strong pain. Interestingly 3 patients (aging more than 65 years) reported no pain.  
For pain treatment usually the patients received NSAIDS, acetaminophen, weak opioids, strong opioids, benzodiazepines, anticonvulsants, antidepressants, steroids and muscle relaxant drugs (Figure 5).
We collected data about the pain-killers taken in the past (15.8% of the patients did not answer to this question): 229 patients (64.9%) assumed at least one NSAID, 146 patients (41.4%) acetaminophen, 127 patients (36%) weak opioids, 59 patients (16.7%) strong opioids,  20 patients (5.7%) antidepressants, 29 patients (8.2%) benzodiazepines, 83 patients (23.5%) anticonvulsants, 49 patients (13.9%) steroids  and 95 patients (26.9%) muscle relaxant drugs. Noteworthy only 21.8 percent of the patients had taken 1 drug, 22.4 percent received 2 medications, 15 percent 3 and 24.9 percent received more than 3 drugs.
Many patients were also treated with physical and interventional therapies such as massage, physiotherapy, iontophoresis, acupuncture, neural blockade (e.g., epidural blocks, facet blocks, neurolysis).  We asked patients to report previously received treatments:  100 patients (28.3%) received massages, 34 (9.6%) patients magnetotherapy, 13 (3.7%) anesthetic blocks, 78 (22.1%) TENS, 66 (18.7%) injections, 12 (3.4%) tractions, 31 (8.8%) iontophoresis, 58 (16.4%) physiokinetic therapy, 28 patients (7.9%) were treated with acupuncture and 34 (9.6%) patients received other treatments.
 
Discussion
Chronic non-cancer pain is a huge problem affecting a large number of individuals. The severity and impact of pain on everyday life is the result of many factors rather than the direct extent of the tissue damage and sometimes pain becomes the disease itself.  A systematic review17 reported the prevalence of chronic pain, as defined by IASP (pain without apparent biological value that has persisted beyond the normal tissue healing time, usually taken 3 months) to be 35.5 percent in the general adult population.
First of all, in this study we need to mention the increase in the total number of patients coming at our Unit in the last years, with no difference in gender distribution compared to the previous survey. The majority of patients continued to be represented by women, although men reached the Pain Unit earlier. In 2014 the sample was also more compliant in answering the questionnaire, even though the mean age was similar.  Our population remain fairly young (mean age, 63.6 years), but it is representative of the sample who fulfilled the questionnaire.
The patients population came from areas closer to the pain center, compared to the 2008 survey, probably because more pain centers arose in the last years in Italy and at II level centers arrive only the most severe cases. The patients were referred to our Unit mostly by their GPs (45.3% versus 35.5% in 2008) than other specialists (e.g. neurologists, orthopedics or physiatrists), this data reflect the successful spread of information about pain management,  the increased attention to pain as disease to treat and the need for a pain specialist. Furthermore the patients’ knowledge about pain management and pain service grew, thanks also to media information.
However, the patients arrived to our Pain Unit after almost the same amount of time if compared to the 2008 (53 months versus 56), but the range was even wider. If considering this data in relation to the mean NRS the conclusion is that many patients keep suffering from poorly controlled pain for very long time, as confirmed from other data on pain epidemiology in western society. The referral to a Pain Center could be due to increase in pain intensity or exacerbation of recurrent pain; usually the patient is referred when other different specialists failed to provide pain relief, mainly because they tried to treat the illness rather than pain. Often the patients are not even asked about their pain intensity and if asked the doctors refer rarely to any pain scale. Probably, in our society pain is still considered a symptom and not a disease that needs a rapid and appropriate treatment. This condition drives to the unfortunate and well-known consequences of work absence, job lost, sleep impairment, depression, social and health costs.
The mean NRS score was lower than 2008 (6.7 versus 8), probably because patients receive more pain treatments. The NRS age-related pattern is the same reported in other epidemiologic studies6, accounting for the highest rate of pain in the age group 61-80 years, not corresponding with the working age.
The areas interested by pain remain similar to the ones described in 2008 survey.
Considering the pain management received by the patients before coming to our Center, we noted an increase in the overall physical therapies (i.e. massages, physiotherapy) and pain-killers use, except for antidepressant agents. Especially the anti-inflammatory drugs, including acetaminophen and steroids, have been used largely (NSAIDs have been administered to the 64.9% of the patients versus 40% in 2008, and acetaminophen 41.4% versus 20%). The NSAIDs can treat nociceptive pain with an inflammatory component but they have a list of well-known side-effects (such as gastric problems, renal impairment or bleeding), that are not reported for acetaminophen that was underused in the past despite its safety profile and its sparing effect relative to weak or strong opioids co-administration.
We noted a significant increase in the opioids use, both for weak (from 24.8% to 36% of the sample) and strong (from 4.3% to 16.7%) drugs and this is probably related to law 38/2010 facilitation of opioid prescription. Considering the mean pain score and the duration of pain, opioids use is more than reasonable from both GPs and specialists (other than pain specialist)18,19,20. However in Italy opioid consumption is still one of the lowest in Europe (IMS Health, 2015)21.
The use of adjuvant drugs is greater than reported in a European survey6, 40.7 percent of our sample received anticonvulsants, muscle relaxants and antidepressant agents, while the European use accounted for less than 5 percent. Benzodiazepines, antidepressant and antiepileptic drugs are very useful in some types of pain (i.e. neuropathic), quite often misdiagnosed with the risk of poor pain control. The biggest part of the population received at least 2 or more medications. Another important increase was observed in the number of physical or instrumental therapies (i.e. massages, physiotherapy) with the related costs compared with the lack of efficacy in our patient population.
The above mentioned results arose from a retrospective observational survey and our aim was to understand the trend in pain epidemiology and management in the last years in Italy, as we conducted the study in one of the most important Pain Unit in the country, where many patients come from the other regions.  However the database was not totally complete, as not all patients answered all the questions and the results may be influenced by the education of the patients who fulfilled the questionnaire even if we did not find age differences in the group of patients not answering the questionnaire.

Conclusion
In conclusion our results on the epidemiology show that the number of patients suffering from chronic pain who get a second level Pain Unit is large; it remarks that pain is an important health and social issue that needs a urgent answer. Pain management remains suboptimal in terms of patient’s care leading to the increase in health care costs related to pain treatment.

Published
12nd January 2017
Corresponding author
Laura Demartini
laura.demartini@icsmaugeri.it

References
21) Report by the IMS Institute for Healthcare Informatics. 2015
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