Publications by authors named "Massimo Mammucari"

37 Publications

Web Axillary Pain Syndrome-Literature Evidence and Novel Rehabilitative Suggestions: A Narrative Review.

Int J Environ Res Public Health 2021 10 2;18(19). Epub 2021 Oct 2.

Department of Oral Medical Science and Biotechnology, G. D'Annunzio University of Chieti-Pescara, 66100 Chieti, Italy.

Axillary web syndrome (AWS) is defined as a visible and palpable network of cords in the skin of the axillary cavity that are tensed by shoulder abduction following surgery for breast cancer, causing significant functional limits of the ipsilateral upper limb (UL) and pain. The purpose of this narrative review is to discuss rehabilitation approaches for greater efficacy with respect to pain and novel suggestions. AWS is a frequent complication of axillary lymphadenectomy that necessitates a thorough follow-up in the medium to long term. Physiotherapy is effective in the treatment of functional limb deficits, the management of pain, and the treatment of upper limb disability. The best management approach involves the use of soft tissue techniques to slow the natural course of the syndrome, in association with therapeutic exercises for functional recovery and muscle strengthening. AWS is linked secondary lymphedema, requiring integration with manual lymphatic drainage. The physiotherapy management of AWS is currently fragmented, and insufficient information is available on the nature of the disease. Thus, randomized and controlled studies that compare rehabilitation approaches in AWS are desirable, including the possibility of using mesotherapy in the treatment of axillary and upper limb pain.
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http://dx.doi.org/10.3390/ijerph181910383DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8507961PMC
October 2021

Multidimensional Statistical Technique for Interpreting the Spontaneous Breakthrough Cancer Pain Phenomenon. A Secondary Analysis from the IOPS-MS Study.

Cancers (Basel) 2021 Aug 10;13(16). Epub 2021 Aug 10.

Division of Anesthesia and Pain Medicine, Istituto Nazionale Tumori, IRCCS Fondazione G. Pascale, 80100 Naples, Italy.

Breakthrough cancer pain (BTcP) is a temporary exacerbation of pain that "breaks through" a phase of adequate pain control by an opioid-based therapy. The non-predictable BTcP (NP-BTcP) is a subtype of BTcP that occurs in the absence of any specific activity. Since NP-BTcP has an important clinical impact, this analysis is aimed at characterizing the NP-BTcP phenomenon through a multidimensional statistical technique. This is a secondary analysis based on the Italian Oncologic Pain multiSetting-Multicentric Survey (IOPS-MS). A correlation analysis was performed to characterize the NP-BTcP profile about its intensity, number of episodes per day, and type. The multiple correspondence analysis (MCA) determined the identification of four groups (phenotypes). A univariate analysis was performed to assess differences between the four phenotypes and selected covariates. The four phenotypes represent the hierarchical classification according to the status of NP-BTcP: from the best (phenotype 1) to the worst (phenotype 4). The univariate analysis found a significant association between the onset time >10 min in the phenotype 1 (37.3%)' vs. the onset > 10 min in phenotype 4 (25.8%) ( < 0.001). Phenotype 1 was characterized by the gastrointestinal type of cancer (26.4%) with respect to phenotype 4, where the most frequent cancer affected the lung (28.8%) ( < 0.001). Phenotype 4 was mainly managed with rapid-onset opioids, while in phenotype 1, many patients were treated with oral, subcutaneous, or intravenous morphine (56.4% and 44.4%, respectively; = 0.008). The ability to characterize NP-BTcP can offer enormous benefits for the management of this serious aspect of cancer pain. Although requiring validation, this strategy can provide many indications for identifying the diagnostic and therapeutic gaps in NP-BTcP management.
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http://dx.doi.org/10.3390/cancers13164018DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8391336PMC
August 2021

A Call to Action by the Italian Mesotherapy Society on Scientific Research.

Drug Des Devel Ther 2021 12;15:3041-3047. Epub 2021 Jul 12.

Department of Vascular Surgery, Limb Salvage and Diabetic Foot, IDI-IRCCS, Rome, Italy.

Mesotherapy (local intradermal therapy, LIT) is a technique used to slowly spread drugs in tissues underlying the site of injection to prolong the pharmacological effect with respect to intramuscular injection. Recommendations for proper medical use of this technique have been made for pain medicine and rehabilitation, chronic venous disease, sport medicine, musculoskeletal disorders, several dermatological conditions, skin ageing, and immune-prophylaxis. Although mesotherapy is considered a valid technique, unresolved questions remain, which should be answered to standardize methodology and dosing regimen as well as to define the right indications in clinical practice. New randomized controlled trials are needed to test single products (dose, frequency of administration, efficacy and safety). Even infiltration of substances for dermo-cosmetic purposes must be guided by safety and efficacy tests before being proposed by mesotherapy. In this article, we put forth a preclinical and clinical research plan and a health technology assessment as a call to action by doctors, researchers and scientific societies to aid national health authorities in considering mesotherapy for prevention, treatment and rehabilitation paths.
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http://dx.doi.org/10.2147/DDDT.S321215DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8285234PMC
July 2021

A Longitudinal Study of Breakthrough Cancer Pain: An Extension of IOPS-MS Study.

J Clin Med 2021 May 24;10(11). Epub 2021 May 24.

Medical Oncology Department, Campus Bio-Medico University of Rome, 00128 Rome, Italy.

The aim of this study was to longitudinally assess the characteristics of background pain and breakthrough pain (BTcP), analgesic treatment, and satisfaction with treatment four weeks after the first assessment.

Methods: Adult cancer patients with a diagnosis of BTcP were included. At T0, age, gender, visit setting, cancer diagnosis, the extent of the disease, ongoing anticancer treatments, and Karnofsky level were recorded. The background pain intensity in the last 24 h (on a numerical scale 0-10), opioids used for background pain, and their doses, expressed as oral morphine equivalents (OME), as well as other analgesic drugs, were recorded. The number of BTcP episodes, their intensity, predictability and precipitating factors, onset duration of untreated episodes, and interference with daily activities were collected. Analgesics and doses used for BTcP, and the mean time to meaningful pain relief after taking medication, were assessed. The level of satisfaction with BTcP medication was also assessed. Adverse effects to be attributed to these medications were also recorded. At T4, the same data were evaluated.

Results: After one-month follow-up, patients had a lower number of BTcP episodes and peak intensity, possibly due to the optimization of background analgesia. The principal characteristics of BTcP did not change significantly.

Conclusion: A careful and continuous assessment should be guaranteed to all patients to limit the burden induced by BTcP, other than treating BTcP episodes with short-onset opioids.
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http://dx.doi.org/10.3390/jcm10112273DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8197313PMC
May 2021

Intradermal Vaccination: A Potential Tool in the Battle Against the COVID-19 Pandemic?

Risk Manag Healthc Policy 2021 20;14:2079-2087. Epub 2021 May 20.

Primary Care Unit ASL RM 1, Rome, Italy.

This narrative review is the final output of an initiative of the SIM (Italian Society of Mesotherapy). A narrative review of scientific literature on the efficacy of fractional intradermal vaccination in comparison with full doses has been conducted for the following pathogens: influenza virus, rabies virus, poliovirus (PV), hepatitis B virus (HBV), hepatitis A virus (HAV), diphtheria-tetanus-pertussis bacterias (DTP), human papillomavirus (HPV), Japanese encephalitis virus (JE), meningococcus, varicella zoster virus (VZV) and yellow fever virus. The findings suggest that the use of the intradermal route represents a valid strategy in terms of efficacy and efficiency for influenza, rabies and HBV vaccines. Some systematic reviews on influenza vaccines suggest the absence of a substantial difference between immunogenicity induced by a fractional ID dose of up to 20% and the IM dose in healthy adults, elderly, immunocompromised patients and children. Clinical studies of remaining vaccines against other pathogens (HAV, DTP bacterias, JE, meningococcal disease, VZV, and yellow fever virus) are scarce, but promising. In the context of a COVID-19 vaccine shortage, countries should investigate if a fractional dosing scheme may help to save doses and achieve herd immunity quickly. SIM urges the scientific community and health authorities to investigate the potentiality of fractionate intradermal administration in anti-COVID-19 vaccination.
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http://dx.doi.org/10.2147/RMHP.S309707DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8144901PMC
May 2021

Oxycodone/Acetaminophen: The Tailoring Combination Treatment for Specific Clinical Profile of Opioid Well-Responsive Cancer Pain.

Cancer Manag Res 2021 19;13:1747-1756. Epub 2021 Feb 19.

Primary Care Unit, ASL RM1, Rome, 00165, Italy.

Background: International guidelines recommend moderate-to-severe cancer pain to be treated with strong opioids. However, pain management remains an unsolved matter, at least in the demanding oncology and palliative care setting. Although cancer pain consists of multiple components, which interact in complex ways where combination therapy can better intercept multiple pain characteristics, few studies have used a non-opioid/opioid association to exploit possible synergistic actions. Even the efforts of a recent approach emphasizing appropriate pain assessment and accurate classification to obtain personalized pain management have not produced a satisfactory analgesic strategy.

Objective: This analysis was intended to evaluate the effectiveness of the immediate release fixed combination of oxycodone/acetaminophen (OxyIR/Par) for the treatment of moderate-to-severe intensity background pain used alone or in combination with other strong opioids in cancer patients with breakthrough cancer pain (BTcP). This is a secondary analysis of a wider observational, prospective, multicenter study [Italian Oncologic Pain multiSetting Multicentric Survey (IOPS-MS)] performed on 179 patients treated with opioids for cancer pain who received the fixed combination of oxycodone/acetaminophen (OxyIR/Par) for the treatment of background pain (BGP).

Results: Cancer patients with breakthrough cancer pain and controlled BGP (Background Pain) were classified according to the presence of analgesic therapy with tablets of fixed combination OxyIR/Par alone (group A, n=120) or tablets of fixed combination OxyIR/Par combined with other strong opioids (group B, n=59). Clinical features of group A were different to group B: higher mean Karnofsky Performance Status Index 70.3% (95% CI=67.2-73.5; median=70, CI=60-80) vs 58.3 (95% CI=53.4-63.2; median=50, CI=45-70) (<0.001), and mainly group A patients were treated in an ambulatory setting (55.0% group A vs 33.9% group B) (p<0.001). Both groups had managed BGP with similar mean dosages (group A: 12.0, CI=10.5-13.4; group B: 13.1, CI=11.0-15.1) and frequencies of OxyIR/Par alone for group A and in association to other opioids for group B, but Breakthrough cancer Pain (BTcP) exhibited different characteristics in the two groups, showing a lower mean intensity numerical rating scale (NRS) of 7.5 (95% CI=7.2-7.7; median=7, CI=7-8 group A) vs 7.9 (95% CI=7.6, 8.2; median= 8, CI=7-9 group B) (=0.04) and a higher percentage of patients had a faster onset, defined as the maximum intensity reached in less than 10 minutes, 81.7% (N=98) in group A vs 59.3% (n=35) in group B (=0.002).

Conclusion: This is the first analysis about the efficacy of an immediate-release fixed combination of OxyIR/Par in the real world for moderate-to-severe background cancer pain and breakthrough cancer pain. The oral fixed combination OxyIR/Par provided an adequate level of analgesia for moderate-severe background cancer pain, in a different cohort of cancer patients with different performance status, both in ambulatory and palliative settings. The low dosage of fixed combination OxyIR/Par was effective alone or in association with other opioids.
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http://dx.doi.org/10.2147/CMAR.S290551DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7903954PMC
February 2021

Breakthrough Cancer Pain Clinical Features and Differential Opioids Response: A Machine Learning Approach in Patients With Cancer From the IOPS-MS Study.

JCO Precis Oncol 2020 4;4. Epub 2020 Nov 4.

Pain Therapy Unit, "A. Businco" Hospital, ASL 8, Cagliari, Italy.

Purpose: A large proportion of patients with cancer suffer from breakthrough cancer pain (BTcP). Several unmet clinical needs concerning BTcP treatment, such as optimal opioid dosages, are being investigated. In this analysis the hypothesis, we explore with an unsupervised learning algorithm whether distinct subtypes of BTcP exist and whether they can provide new insights into clinical practice.

Methods: Partitioning around a k-medoids algorithm on a large data set of patients with BTcP, previously collected by the Italian Oncologic Pain Survey group, was used to identify possible subgroups of BTcP. Resulting clusters were analyzed in terms of BTcP therapy satisfaction, clinical features, and use of basal pain and rapid-onset opioids. Opioid dosages were converted to a unique scale and the BTcP opioids-to-basal pain opioids ratio was calculated for each patient. We used polynomial logistic regression to catch nonlinear relationships between therapy satisfaction and opioid use.

Results: Our algorithm identified 12 distinct BTcP clusters. Optimal BTcP opioids-to-basal pain opioids ratios differed across the clusters, ranging from 15% to 50%. The majority of clusters were linked to a peculiar association of certain drugs with therapy satisfaction or dissatisfaction. A free online tool was created for new patients' cluster computation to validate these clusters in future studies and provide handy indications for personalized BTcP therapy.

Conclusion: This work proposes a classification for BTcP and identifies subgroups of patients with unique efficacy of different pain medications. This work supports the theory that the optimal dose of BTcP opioids depends on the dose of basal opioids and identifies novel values that are possibly useful for future trials. These results will allow us to target BTcP therapy on the basis of patient characteristics and to define a precision medicine strategy also for supportive care.
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http://dx.doi.org/10.1200/PO.20.00158DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7713587PMC
November 2020

Mesotherapy: From Historical Notes to Scientific Evidence and Future Prospects.

ScientificWorldJournal 2020 1;2020:3542848. Epub 2020 May 1.

Department of Clinical Science and Translational Medicine, Tor Vergata University, Rome, Italy.

Intradermal therapy, known as mesotherapy, is a technique used to inject a drug into the surface layer of the skin. In particular, it involves the use of a short needle to deposit the drug in the dermis. The intradermal microdeposit modulates the drug's kinetics, slowing absorption and prolonging the local mechanism of action. It is successfully applied in the treatment of some forms of localized pain syndromes and other local clinical conditions. It could be suggested when a systemic drug-sparing effect is useful, when other therapies have failed (or cannot be used), and when it can synergize with other pharmacological or nonpharmacological therapies. Despite the lack of randomized clinical trials in some fields of application, a general consensus is also reached in nonpharmacological mechanism of action, the technique execution modalities, the scientific rationale to apply it in some indications, and the usefulness of the informed consent. The Italian Mesotherapy Society proposes this position paper to apply intradermal therapy based on scientific evidence and no longer on personal bias.
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http://dx.doi.org/10.1155/2020/3542848DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7305548PMC
June 2021

Doctors and Nurses' Knowledge and Attitudes Towards Pediatric Pain Management: An Exploratory Survey in a Children's Hospital.

J Pain Palliat Care Pharmacother 2019 Sep - Dec;33(3-4):107-119. Epub 2019 Nov 5.

Despite the existence of protocols for effective pain control, pediatric pain is still high, due to scarce knowledge of its treatment, especially regarding opioids. This study aimed to evaluate doctors and nurses' knowledge of pain treatment and the use of opioids in children, before and after the implementation of Law 38/2010, that represented an important step in guaranteeing patients' rights to gain access to appropriate services for pain control and palliative care in Italy and in establishing the obligation of specific training programs in this matter for health professionals. An questionnaire was developed and administered before (investigation A) and after (investigation B) the issuance of the Law. In B both doctors and nurses showed a slight but significant increase in correct answers and a reduction in incorrect ones, mainly concerning the category . In both investigations doctors and nurses showed adequate general knowledge, yet there were some gaps regarding the specific knowledge of opioid drugs. Most of the participants were not familiar with the Law and its provisions.Investigation B showed an improvement in health professionals' knowledge, perhaps due to a hospital environment that followed the provisions of Law 38/2010. Nevertheless, the establishment of training courses according to the Law is needed to improve the knowledge of opioids, as well as to dispel deeply rooted myths and prejudices on pediatric pain.
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http://dx.doi.org/10.1080/15360288.2019.1686100DOI Listing
April 2020

Factors Influencing the Clinical Presentation of Breakthrough Pain in Cancer Patients.

Cancers (Basel) 2018 Jun 1;10(6). Epub 2018 Jun 1.

PainTherapy, S. Croce e Carle Hospital, 12100 Cuneo, Italy,

The aim of this study was to identify potential variables influencing the clinical presentation of breakthrough cancer pain (BTP). Cancer patients with a diagnosis of BTP were enrolled. Demographic and clinical characteristics, as well as background pain and BTP characteristics were collected. Multivariate analyses were conducted to assess the correlation between BTP characteristics and the variables examined. Data of 4016 patients were analysed. Average daily number of BTP episodes was 2.4, mean intensity was 7.5, and a mean duration was 43.3 min. A short onset BTP was observed in 68.9% of patients. In 30.5% of patients BTP was predictable. There were 86.0% of participants who reported a marked interference of BTP with their daily activities. Furthermore, 86.8% of patients were receiving opioids for the management of BTP. The average time to meaningful pain relief was 16.5 min and 70.9% of patients were satisfied with their BTP medications. Age, head and neck cancer, Karnofsky, background pain intensity, predictable and fast onset BTP were independently associated with the number of BTP episodes. BTP pain intensity was independently associated with background pain intensity, fast onset BTP, and Karnofsky. Neuropathic pain mechanism was independently associated with unpredictable BTP. Variables independently associated with a longer duration of BTP were age, place of visit, cancer diagnosis, disease-oriented therapy, background pain intensity and mechanism, and unpredictable BTP. Age, Karnofsky, background pain intensity, fast onset, and long duration of BTP were independently associated with interference with daily activity. BTP has a variable presentation depending on interdependent relationships among its different characteristics.
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http://dx.doi.org/10.3390/cancers10060175DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6025469PMC
June 2018

Assessment and treatment of breakthrough cancer pain: from theory to clinical practice.

J Pain Res 2017 12;10:2147-2155. Epub 2017 Sep 12.

Department of Pharmacy and Biotechnology, University of Bologna, Bologna, Italy.

Breakthrough cancer pain (BTcP) is a common condition in oncological patients. However, its management is still suboptimal. Improved knowledge of BTcP and its management in clinical practice may have immediate importance for all physicians involved in the supportive care of cancer patients. This review critically discusses the most important concepts for the correct diagnosis of BTcP and presents some intriguing cases of the management of this condition in clinical practice. Overall, the most appropriate therapeutic choice appears to be a rapid-onset opioid (ROO), and in particular, the nasal route of administration is the quickest and most convenient mode of administration for the management of BTcP, especially when the patient needs rapid resolution of pain. To this end, intranasal fentanyl spray may have a particular relevance in clinical practice. Future research should focus on accepted definitions of BTcP to investigate the optimal management of this highly heterogeneous pain condition. Therapeutic decision-making of patients, clinicians, and payers will likely be driven from results of well-designed clinical trials of ROOs.
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http://dx.doi.org/10.2147/JPR.S135807DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5604430PMC
September 2017

Erratum to: Breakthrough pain and its treatment: critical review and recommendations of IOPS (Italian Oncologic Pain Survey) expert group.

Support Care Cancer 2017 08;25(8):2673-2674

Palliative Care, Pain Therapy and Rehabilitation, National Cancer Institute, Milan, Italy.

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http://dx.doi.org/10.1007/s00520-017-3739-zDOI Listing
August 2017

Breakthrough Cancer Pain: Preliminary Data of The Italian Oncologic Pain Multisetting Multicentric Survey (IOPS-MS).

Adv Ther 2017 01 21;34(1):120-135. Epub 2016 Nov 21.

Palliative Care and Oncologic Pain Service, S. Camillo-Forlanini Hospital, Rome, Italy.

Introduction: An ongoing national multicenter survey [Italian Oncologic Pain multiSetting Multicentric Survey (IOPS-MS)] is evaluating the characteristics of breakthrough cancer pain (BTP) in different clinical settings. Preliminary data from the first 1500 cancer patients with BTP enrolled in this study are presented here.

Methods: Thirty-two clinical centers are involved in the survey. A diagnosis of BTP was performed by a standard algorithm. Epidemiological data, Karnofsky index, stage of disease, presence and sites of metastases, ongoing oncologic treatment, and characteristics of background pain and BTP and their treatments were recorded. Background pain and BTP intensity were measured. Patients were also questioned about BTP predictability, BTP onset (≤10 or >10 min), BTP duration, background and BTP medications and their doses, time to meaningful pain relief after BTP medication, and satisfaction with BTP medication. The occurrence of adverse reactions was also assessed, as well as mucosal toxicity.

Results: Background pain was well controlled with opioid treatment (numerical rating scale 3.0 ± 1.1). Patients reported 2.5 ± 1.6 BTP episodes/day with a mean intensity of 7.5 ± 1.4 and duration of 43 ± 40 min; 977 patients (65.1%) reported non-predictable BTP, and 1076 patients (71.7%) reported a rapid onset of BTP (≤10 min). Higher patient satisfaction was reported by patients treated with fast onset opioids.

Conclusions: These preliminary data underline that the standard algorithm used is a valid tool for a proper diagnosis of BTP in cancer patients. Moreover, rapid relief of pain is crucial for patients' satisfaction. The final IOPS-MS data are necessary to understand relationships between BTP characteristics and other clinical variables in oncologic patients.

Funding: Molteni Farmaceutici, Italy.
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http://dx.doi.org/10.1007/s12325-016-0440-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5216057PMC
January 2017

Should the General Practitioner Consider Mesotherapy (Intradermal Therapy) to Manage Localized Pain?

Pain Ther 2016 Jun 26;5(1):123-6. Epub 2016 May 26.

Department of Clinical Science and Translational Medicine, Policlinico di Tor Vergata, University of Rome Tor Vergata, Rome, Italy.

Wide variations in the types of pain and response to analgesic pharmacotherapy mean that a variety of treatment strategies are needed. One approach is mesotherapy (intradermal therapy). This consists of microinjections into the skin and is ideally suited to the management of localized pain. Advantages include increasing the duration of drug activity, reduced risk of adverse events and interactions, and possible synergy with other therapies. Mesotherapy provides general practitioners with another tool for the treatment of local pain. However, it is important to provide patients with full details of the pros and cons of this approach and obtain informed patient consent.
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http://dx.doi.org/10.1007/s40122-016-0052-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4912973PMC
June 2016

Retrospective Evaluation of a Fixed-Dose Combination of Oxycodone and Acetaminophen to Manage Moderate Pain: The Lower the Better.

Adv Ther 2016 06 3;33(6):1025-32. Epub 2016 May 3.

Department of Clinical Science and Translational Medicine, University of Rome Tor Vergata, Rome, Italy.

Introduction: Oxycodone is one of the most commonly used opioid analgesics in the clinical management of pain. The present retrospective analysis aimed to determine the dose of oxycodone that could achieve effective control of moderate pain when combined with a fixed dose of acetaminophen, and the time required to reach a clinically relevant reduction in intensity of pain.

Methods: Data of patients treated with a combination of oxycodone (5, 10, and 20 mg) and acetaminophen (325 mg) were evaluated for gender, current disease condition, basal pain intensity, total daily dose, days of controlled pain at the initial low dose, and pain intensity after treatment using a numeric pain rating scale.

Results: Data from a total of 491 patients were assessed; of these 93.5% of patients experienced persistent non-cancer pain and had an average baseline pain score of 5.68 ± 1.35. For the overall population, the pain score was reduced to 2.49 ± 1.71 with a mean dose of 8.68 ± 4.96 mg oxycodone after 21.60 ± 6.12 days of treatment with the combination. Almost 97% of the patients who reported relief of pain received 1.61 ± 0.67 doses of oxycodone 5 mg combined with 325 mg of acetaminophen.

Conclusion: A low-dose combination of oxycodone with acetaminophen can be effective in the management of moderate pain and may help in reducing the treatment-associated adverse reactions and drug dependence.

Funding: Sponsorship for article processing charges was provided by Molteni Farmaceutici, Florence, Italy.
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http://dx.doi.org/10.1007/s12325-016-0339-0DOI Listing
June 2016

Analgesics or pain, who is the real enemy? Suggestions from the CDC guidelines.

BMJ 2016 Apr 12;353:i2028. Epub 2016 Apr 12.

Primary Care, ASL RM1, Rome, Italy.

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http://dx.doi.org/10.1136/bmj.i2028DOI Listing
April 2016

The management of chronic osteoarticular pain in the outpatient setting: results of an ASON audit.

Joints 2015 Jul-Sep;3(3):146-50. Epub 2016 Jan 28.

Local Health Authority NA 1, Naples, Italy.

Unlabelled: The management of patients with chronic osteoarticular pain requires a comprehensive clinical evaluation and a multidisciplinary approach. Thirty specialists (orthopedic specialists, rheumatologists, physiatrists), members of the National Association of Osteoarticular Specialists (ASON), attended a specific training course in the use of a standardized medical record designed for the management of osteoarticular pain in outpatients. An audit on 888 medical records was later conducted and it showed that use of this instrument led to an improvement in the diagnostic-therapeutic approach. A complete and accurate medical record compilation process may also promote collaborative interaction among the healthcare practitioners involved and this can result in greater efficiency and continuity of care. ASON recommends expediting the use of electronic tools to facilitate information-sharing among pain care specialists. This study shows that the use of electronic tools facilitates the exchange of information between healthcare providers. ASON supports the adoption of similar instruments in order to improve the management of chronic pain.

Level Of Evidence: Level III, cross-sectional survey.
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http://dx.doi.org/10.11138/jts/2015.3.3.146DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4732781PMC
February 2016

Breakthrough pain and its treatment: critical review and recommendations of IOPS (Italian Oncologic Pain Survey) expert group.

Support Care Cancer 2016 Feb 5;24(2):961-968. Epub 2015 Oct 5.

Palliative Care, Pain Therapy and Rehabilitation, National Cancer Institute, Milan, Italy.

Controversies exist about the definition and epidemiology of breakthrough cancer pain (BTcP), the pharmacological treatment options, drug dosing, and how to select the medications for BTcP among the new fentanyl products. Existing data were critically evaluated to provide recommendations by an expert group. An algorithm to diagnose BTcP should be used followed by a careful assessment. Fentanyl products provide efficacy and rapidity of action to counteract the temporal pattern of BTcP. The doses of opioids used for background pain should guide the choice of the doses of fentanyl products. The choice of fentanyl products should be based on individual clinical conditions.
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http://dx.doi.org/10.1007/s00520-015-2951-yDOI Listing
February 2016

[Multidisciplinary care pathway to manage osteoarticular chronic pain. ASON proposal].

Recenti Prog Med 2015 Mar;106(3):118-24

As recognized by law no. 38 of March 15, 2010 patients with chronic pain should have access to an appropriate diagnostic and therapeutic path with continuity of care. In addition to clinical guidelines it is necessary to implement a multidisciplinary care to manage patients with osteoarticular chronic pain to start an early analgesic treatment and to optimize the health system resources. Through a triage territorial of patients with pain we identify the most complex cases to be sent to the network of pain (Spoke and Hub), and we differentiate those that must be managed in a territorial path. The proposal by National Association Osteoarticular Specialists (ASON) suggests a multidisciplinary personalized path, coordinated by general practitioners and specialists, aims to improve patient-health system relationship.
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http://dx.doi.org/10.1701/1806.19700DOI Listing
March 2015

Italian Oncological Pain Survey (IOPS): a multicentre Italian study of breakthrough pain performed in different settings.

Clin J Pain 2015 Mar;31(3):214-21

*Anesthesia and Intensive Care & Pain Relief and Supportive Care, La Maddalena Cancer Center, Palermo †Emergency Care, Critical Care Medicine, Pain Medicine and Anesthesiology Department, Tor Vergata University of Rome ‡Anesthesiology, Resuscitation, and Pain Therapy Department, Umberto I Hospital ¶Molecular and Clinical Medicine Medical Oncology, La Sapienza University of Rome #IDI-IRCCS ‡‡‡‡Primary Care, ASL RM F, Rome §Anesthesiology, Resuscitation, and Pain Therapy Department ¶Abdominal Medical Oncology, National Cancer Institute, IRCCS Foundation Pascale ††Medical Oncology, A.O.R.N "A. Cardarelli" Hospital †††Pain Relief, A.O. Dei Colli, Monaldi Hospital, Naples ∥Palliative Care ASL3, Genoa ##Palliative Care, Gerontology and Physical Education Department, E.O. Galliera Hospitals, Genoa **Pain Relief, Palliative Care, Oncology Department, Careggi Hospital, Florence ‡‡Hematology Oncology Center Subalpine (COES), A.O. City Health and Science, Molinette §§§Palliative Care, FARO Foundation, Turin §§IRCCS Foundation National Cancer Institute of Milan, Milan ***Palliative Care, Pain Relief, ASL 13 Mirano Veneto Region ‡‡‡Palliative Care, Pain Relief, Infermi Hospital, Rimini ∥∥∥Medical Oncology, Humanitas Oncology Center of Catania, Catania ¶¶¶Medical Oncology 1, Careggi Hospital, Florence ###Pain Relief, IRCCS Veneto Oncological Institute, Padua ****Pain Relief, Palliative Care, AV3 Macerata Hospital, Macerata ††††Medical Oncology A.O. Treviglio, Bergamo, Italy ∥∥European Palliative Care Research Center, Norwegian University of Science and Technology, Trondheim, Norway.

Objective: A survey of breakthrough pain (BTP) was performed in five palliative care units (PCU), seven oncology departments (ONC), and nine pain clinics (OPC).

Methods: A standard algorithm was used to confirm the diagnosis of BTP of patients refereed to different settings.

Results: 1,412 evaluable cancer patients were enrolled. 53.9% were males and the mean age was 63.7±13.1 years. The mean intensity of background pain was 2.8±0.73. Patients reported 2.4±1.1 BTP episodes/day with a mean intensity of 7.37±1.28. 80.6% patients reported that the BTP had a significant negative impact in everyday life. The majority of patients reported a fast onset of BTP, which was predictable in 50.7% of cases, while BTP with a gradual onset (>10 min) was less predictable (29%) (P=0.001). PCU patients were older, had lower Karnofsky levels, a lower number of BTP episodes/day, a slow onset of BTP onset, and a less predictable BTP. Cancer diagnosis was performed a mean of 23.5 months (SD±32.8) before the assessment. The mean duration of background pain was 3.5 months (SD±3.5), and the mean duration of any analgesic treatment was 2.5 months (SD±3). BTP started a mean of 2.2 months (SD±1.9) before the assessment. Characteristics of BTP were influenced by the course of disease, as well as the duration of background pain and initiation of BTP. Most patients took rapid onset opioids and were satisfied with the treatment. BTP diagnosis was prevalently made by ONC and OPC physicians, and rarely by GPs.

Conclusion: This survey performed by an Italian observatory expert review group, has confirmed that the BTP represents a clinically relevant condition with a negative impact on the patient's quality of life. BTP was detected in all settings involved. A number of factors are associated with the BTP. Also factors regarding the course of disease and setting of care have been assessed. This information may help in stratifying patients or predicting the risk of development of BTP with specific characteristics.
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http://dx.doi.org/10.1097/AJP.0000000000000161DOI Listing
March 2015

[Role of intensive medical training on Law 38 to improve pain management in primary care].

Recenti Prog Med 2014 Apr;105(4):159-65

The Italian Law no. 38/2010 requires that the physician reports in the medical record the type and the intensity of pain, analgesic therapies and clinical results. We developed a training model for 256 primary care physicians (GPs). After a period of intensive training on the content of the law no. 38, diagnostic and pharmacological approach of pain, we carried out a clinical audit by a web based clinical record to assess doctor's compliance to Law no. 38 and the use of opioids. 2631 patients were assessed (age 71,5±13,7 years; median 74). The mean of chronic non oncologic pain intesity was 5.41±2.0 (static) and 6.10±2.32 (dynamic). After a systematic measurement of pain, a better control of patients was achieved (2.22±2.12 points lower for static, 2.37±2.34 lower for dynamic pain (p<0.001 vs basal time). An increased use of opioids have been detected. GPs have also used strong opioids in opioid-naïve patients, avoiding the first or the second step if intensity of pain detected was severe. In fact, a greater pain control was achieved with oxycodone compared to tramadol or codeine (all of them with normal release and combined with acetaminophen). Chronic non cancer pain remains one of the major clinical problems in the primary care setting, especially in the elderly. The standard measurement of parameters related to pain and the proper use of opioids depends on the scientific update and how this is delivered. GPs are crucial to implement the Law 38 and to increase the degree of complexity of the patient to be properly admitted to a SPOKE/HUB center.
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http://dx.doi.org/10.1701/1459.16129DOI Listing
April 2014

Management of painful bone metastases: our experience according to scientific evidence on palliative radiotherapy.

Anticancer Res 2014 Feb;34(2):1011-4

Radiation Oncology, Second University of Naples, Pza Miraglia, 80131 Naples, Italy.

Aim: Our aim was to evaluate retrospectively the role of the radiotherapy in the multi-disciplinary management of pain due to bone metastases.

Patients And Methods: A total of 305 patients received radiotherapy with or without bisphosphonate and antalgic drugs. Tolerability and efficacy were evaluated using a Numerical Rating Scale, Pain Intensity Difference evaluation scale related to administration of the drug, a 5-point verbal scale of the patients' general impression.

Results: We found differences in some patient subgroups: pain reduction was significantly more evident in patients treated with a single-fraction radiotherapy scheme. Overall, 68% of patients experienced an improvement in pain control using concomitant drugs during radiotherapy.

Conclusion: Our study underlines the role of radiotherapy in the management of metastatic bone pain. The use of rapid-onset opioids to prevent predictable pain is a crucial step in managing radiotherapy. An interdisciplinary approach is recommended.
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February 2014

[Informed consent and experimental treatments: the case of mesotherapy].

Recenti Prog Med 2013 May;104(5):214-7

Società Italiana di Mesoterapia, Rome.

Mesotherapy is a minimally invasive technique based on the introduction of pharmacologically active compounds in the surface layer of the skin. The intradermal route has been known for many years and it has the aim of reducing the dose and slowing the diffusion into the underlying tissues. Mesotherapy requires a clinical diagnosis and informed consent. Patient should be well informed about potential benefits, limitations, and risks (even mild). The process of doctor-patient interaction in mesotherapy is an example of compliance with the basic concept: "first do no harm" and, at the same time, the advantage for the patient to conclude a "therapeutic alliance". We propose a draft form to facilitate the decision-making process.
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http://dx.doi.org/10.1701/1291.14279DOI Listing
May 2013

Intradermal therapy (mesotherapy) with lymdiaral in chronic venous insufficiency and associated fibrosclerotic edema damage: a pilot study.

J Altern Complement Med 2013 Sep 26;19(9):777-81. Epub 2013 Apr 26.

1 Clinical Research of the Service of Aesthetic Medicine , Ospedale Generale San Giovanni Calibita Fatebenefratelli, Isola Tiberina, Rome, Italy .

Objectives: Chronic venous insufficiency (CVI) induces alterations that cause fibrosclerotic edema of the subcutaneous tissue. This study examined the effects of a complex naturopathic compound with vasoactive and antiedema activities (Lymdiaral®) administered intradermally.

Patients: 40 patients with signs and symptoms of CVI and associated fibrosclerotic edema of the subcutaneous tissue.

Outcome Measures: Efficacy was assessed by using clinical investigation, subjective and objective measures, and ultrasonography performed at baseline and after treatment.

Results: Thirty-four patients completed the study; 6 of the original 40 (15%) had stopped for reasons unrelated to study treatment. The treatment was well tolerated. Fifteen adverse reactions were reported among a total of 378 doses administered (3.97%). None of these reactions were severe or required discontinuation of treatment. Subjective symptoms and objective measures improved, and ultrasonography showed statistically significant changes in hypodermal thickness of the medial aspect of the knees.

Conclusions: Its open-label design and small sample size notwithstanding, this study indicates that intradermal therapy, according to the recommendation of the Italian Society of Mesotherapy, may provide a valuable contribution to the treatment of CVI and related fibrosclerotic edema of the subcutaneous tissue by prolonging the local effect of the pharmacologically active compounds. Comparative studies are needed to identify the broader clinical and economic benefits of local therapy compared with other systemic therapies.
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http://dx.doi.org/10.1089/acm.2012.0734DOI Listing
September 2013

Beyond the traditional definition of breakthrough pain: an observational study.

Adv Ther 2013 Mar 25;30(3):298-305. Epub 2013 Feb 25.

Emergency Care, Critical Care Medicine, Pain Medicine and Anesthesiology Department, Tor Vergata Polyclinic, University of Rome Tor Vergata, Rome, Italy.

Introduction: Breakthrough pain (BTP) is traditionally defined as a transitory pain flare in opioid-treated patients with chronic background pain. This definition has, however, been challenged in recent years. This study aimed to analyze BTP prevalence in different pain conditions.

Methods: This was a prospective, non-interventional, observational study conducted from June to September 2011 in two Italian pain treatment reference centres. Consecutive patients aged >18 years with oncological or non-oncological pain were eligible for this study; background pain was acute/ subacute (<3 months) or chronic (>3 months). The characteristics of pain were evaluated by means of a structured interview by physicians, and patients were asked to complete a dedicated clinical study form. The following outcomes were assessed: chronic pain duration (in patients with chronic pain), BTP prevalence, and number and severity of daily BTP episodes. All outcomes were assessed in four populations of patients with: (a) chronic oncological pain; (b) chronic non-oncological pain; (c) non-chronic oncological pain; (d) non-chronic non-oncological pain. The correlation between BTP and gender was also investigated.

Results: Of 1,270 patients with chronic pain, 1,086 had non-oncological pain (85.5%). Most patients (68.6%) with non-oncological pain were female (P = 0.001). Pain duration was significantly longer in non-oncological pain versus oncological pain groups (P = 0.002). BTP prevalence was lower in non-oncological patients (P < 0.001). No differences were reported in terms of number and severity of daily BTP episodes. BTP was more frequent in females with non-oncological pain (P = 0.04). Females had a significantly higher pain severity (P = 0.02) than males.

Conclusion: BTP is frequently reported in patients who do not have BTP according to the traditional definition. BTP frequency and severity is similar in oncological and non-oncological pain.
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http://dx.doi.org/10.1007/s12325-013-0013-8DOI Listing
March 2013

[Continuity of care in heart failure: pilot study of the Tuscany region].

G Ital Cardiol (Rome) 2012 Sep;13(9):615-21

Cardiologia Generale 1, Azienda Ospedaliero-Universitaria Careggi, 50126 Firenze, Italy.

Background: Heart failure (HF) is one of the leading causes of hospitalization and medical expenditure, especially in elderly patients. Cooperation between specialists and general practitioners may improve outcomes. A 1-year hospital-territory disease management program was designed in collaboration with the Tuscany Region and the Ministry of Health involving specialists, general practitioners and nurses to investigate the impact of our model on healthcare organization and hospitalization rates in patients with HF.

Methods: The program used a web-based clinical report form, and monitoring of patients from specialists and nurses was coordinated by the general practitioners. We enrolled 106 patients (78.3% male, mean age 74.6 years), with a mean left ventricular ejection fraction 49% and mean Charlson index 2.2.

Results: A statistically significant reduction was observed in the number of hospitalizations and emergency calls compared with the previous year. HF severity did not substantially changed in 69.8% of patients, whereas it improved in 17.0% and worsened in 13.2% (NYHA class).

Conclusions: Our preliminary data suggest that cooperation between hospitals and medical systems in the territory by means of a web-based clinical report may result in better management of healthcare interventions in the territory with subsequent reduction of hospitalizations. An extension of this model is now ongoing for collecting data from different areas, both within and outside Tuscany.
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http://dx.doi.org/10.1714/1133.12490DOI Listing
September 2012

Role of mesotherapy in musculoskeletal pain: opinions from the italian society of mesotherapy.

Evid Based Complement Alternat Med 2012 13;2012:436959. Epub 2012 May 13.

The Italian Society of Mesotherapy, Rome, Italy.

Mesotherapy is the injection of active substances into the surface layer of the skin. This method allows a slower spread, higher levels, and longer lasting effects of drugs in the tissues underlying the site of injection (skin, muscle, and joint) compared with those following intramuscular injection. This technique is useful when a local pharmacological effect is required and relatively high doses of drug in the systemic circulation are not. Mesotherapy should only be undertaken following a complete clinical workup and subsequent diagnosis. Encouraging results have been reported in randomized, controlled clinical trials and in observational studies involving patients with various forms of musculoskeletal pain. Recommendations by experts from the Italian Society of Mesotherapy for appropriate use of mesotherapy in musculoskeletal pain and an algorithm for treating localized painful conditions are provided.
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http://dx.doi.org/10.1155/2012/436959DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3359685PMC
August 2012

Breakthrough pain in patients referred to pain clinics: the Italian pain network retrospective study.

Adv Ther 2012 May 21;29(5):464-72. Epub 2012 May 21.

Emergency Care, Critical Care Medicine, Pain Medicine and Anesthesiology Department, Tor Vergata Polyclinic, University of Rome Tor Vergata, Rome, Italy.

Introduction: Despite breakthrough pain (BTP) being one of the most severe forms of pain, there are no definitive data on its prevalence.

Methods: The authors performed a retrospective survey of the prevalence of BTP in consecutive patients in four Italian pain clinics, subsequent to application of an Italian law mandating detailed clinical records on pain characteristics, treatment, and results. Mean pain intensity was assessed with a numerical rating scale from 0 to 10.

Results: The authors analyzed records of 1,401 patients (58% women, 33.1% patients with cancer). Transient episodes of severe pain or BTP were referred by 790 patients (56.4%), including 58.2% of the men (342 of 588) and 55.1% of the women (448 of 813). Among the 464 patients with cancer, 70.3% reported daily exacerbation of pain. The mean BTP intensity was 8.31 ± 1.58 and 31.1% of patients reported experiencing three episodes per day.

Conclusion: Despite some limitations of the study, the authors show that transient episodes of severe pain or BTP are significantly present both in cancer and other diseases, and that many patients are not yet receiving appropriate opioid therapy. The authors need validated tools at international level for the diagnosis and treatment of BTP in patients with cancer and for transitory and patients with severe non-cancer pain. A survey at national level is needed to estimate the prevalence of BTP in different settings, to plan specific medical education.
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http://dx.doi.org/10.1007/s12325-012-0022-zDOI Listing
May 2012
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