Investigating Functional Impairment in Chronic Low Back Pain: A Qualitative Study from the Patients and Specialists' Perspectives.

Prompt and appropriate treatment of chronic low back pain (cLBP) is of the utmost importance for preventing relevant disability, high burden of disease, and increasing costs for the healthcare system. Recently, the concept of functional impairment has been associated with any type of chronic pain, and mounting attention has been paid to extending the aims of treatment beyond mere pain remission, including restoration of working capacity, everyday functioning, mobility, and quality of life. Nevertheless, a shared definition of functionality is still lacking. Notably, different specialists involved in the treatment of cLBP such as general practitioners, orthopedists, pain therapists, and physiatrists, and patients themselves have different opinions on what "functional impairment" actually means. On these premises, a qualitative interview study was performed to investigate how the concept of "functionality" is interpreted by different specialists involved in the management of cLBP, and by patients. Overall, all different specialists agreed that functionality should be assessed in clinical practice. However, in spite of several instruments available for evaluating functionality, no homogeneity of behavior is observable.

Musculoskeletal Pain Management and Thermotherapy: An Exploratory Analysis of Italian Physicians' Attitude, Beliefs, and Prescribing Habits.

Purpose: In Italy, musculoskeletal (MSK) disorders are pervasive with one-third of adults seeking medical consultation for a MSK issue in the past year. MSK pain is often treated with local heat applications (LHAs) which can be integrated into MSK care by different specialists and in different settings. Compared to analgesia and physical exercise, LHAs have been less evaluated, and the quality of randomized clinical trials is generally low. The aim of the survey is to assess the knowledge, attitude, perception/practices of general practitioners (GPs), physiatrists and sports medicine doctors towards thermotherapy as delivered by superficial heat pads or wraps. Patients and Methods: The survey was conducted between June and September 2022 in Italy. An online questionnaire with 22 multiple-choice questions was administered to explore the demographics and prescribing habits of the participants; the clinical profile of MSK patients; and physicians' attitude and beliefs about the use of thermotherapy/superficial heat applications in MSK pain management. Results: GPs are at the forefront of the MSK patient journey and preferentially select NSAIDs as first-line option in arthrosis, muscle stiffness, and strain while prescribing heat wraps as preferred choice in presence of muscle spasm/contracture. Similar pattern of prescribing habits was found among specialists who, in contrast to GPs, adopted more frequently ice/cold therapy to relieve pain due to muscle strain and limited paracetamol use. Generally, survey participants agreed on the benefits of thermotherapy in MSK care management, namely increased blood flow and local tissue metabolism as well as connective tissue elasticity and pain relief which all may be of help in attaining pain control and improvement of function. Conclusion: Our findings provided the basis for further investigations aimed at optimizing the MSK patient journey while building up additional evidence supporting the benefit of using superficial heat applications to effectively manage patients with MSK disorders.

To clarify the safety profile of paracetamol for home-care patients with COVID-19: a real-world cohort study, with nested case-control analysis, in primary care.

BACKGROUND AND OBJECTIVE: This study aimed to compare the prescribing patterns of paracetamol in COVID-19 with those for similar respiratory conditions and investigated the association between paracetamol use and COVID-19-related hospitalization/death. METHODS: Using a primary care data source, we conducted a cohort study to calculate the incidence rate of paracetamol use in COVID-19 and for similar respiratory conditions in 2020 and 2019 (i.e. pre-pandemic phase), respectively. In the study cohort, we nested a case-control analyses to investigate the association between paracetamol use and COVID-19-related hospitalizations/deaths. RESULTS: Overall, 1554 (33.4 per 1000) and 2566 patients (78.3 per 1000) were newly prescribed with paracetamol to treat COVID-19 or other respiratory conditions, respectively. Those aged 35-44 showed the highest prevalence rate (44.7 or 99.0 per 1000), while the oldest category reported the lowest value (17.8 or 39.8 per 1000). There was no association for early (OR = 1.15; 95% CI: 0.92-1.43) or mid-term (OR = 1.29; 95% CI: 0.61-2.73) users of paracetamol vs. non-users. Instead, the late users of paracetamol showed a statistically significant increased risk of hospitalization/death (OR = 1.75; 95% CI: 1.4-2.2). CONCLUSIONS: Our findings provide reassuring evidence on the use and safety profile of paracetamol to treat early symptoms of COVID-19 as in other respiratory infections.

A Delphi Consensus Approach for the Management of Chronic Pain during and after the COVID-19 Era.

Due to a lack of published evidence on the topic, a modified Delphi approach was used to develop recommendations useful for chronic pain management during and after the COVID-19 pandemic. Focusing on the available literature and personal clinical expertise, an Italian board of nine professionals from different disciplines identified four main topics: prevention of chronic pain, treatment of chronic pain, consequences of inadequate treatment, and perspectives. They elaborated a semi-structured questionnaire. A multidisciplinary panel of experts in the field of pain management was requested to comment on the statements. Based on the answers provided, a structured questionnaire was prepared (Round 1). It included 21 statements divided into three categories (organizational issues; diagnosis and therapies; telemedicine and future perspectives). A five-point Likert scale was adopted. The threshold for consensus was set at a minimum of 70% of the number of respondents (level of agreement ≥ 4, Agree or Strongly Agree). A final questionnaire with rephrasing of the statements that did not reach the consensus threshold was elaborated (Round 2). A total of 29 clinicians were included in the panel. Twenty clinicians (69%) responded in both the first and second round. After two rounds, consensus (≥70%) was achieved in 20 out of 21 statements. The lack of consensus was recorded for the statement regarding the management of post-COVID pain (55%; Median 4; IQR 2.3). Another statement on telemedicine reached the threshold in the first round (70%), but the value was not confirmed in Round 2 (65%; Median 4; IQR 2). Most of the proposed items reached consensus, suggesting the need to make organizational changes, the structuring of careful diagnostic and therapeutic pathways, and the application of new technologies in pain medicine. Long-COVID-19 care is an issue that needs further research. Remote assistance for chronic pain must be regulated.

A Role for Superficial Heat Therapy in the Management of Non-Specific, Mild-to-Moderate Low Back Pain in Current Clinical Practice: A Narrative Review.

Low back pain (LBP) is a leading cause of disability. It significantly impacts the patient's quality of life, limits their daily living activities, and reduces their work productivity. To reduce the burden of LBP, several pharmacological and non-pharmacological treatment options are available. This review summarizes the role of superficial heat therapy in the management of non-specific mild-to-moderate LBP. First, we outline the common causes of LBP, then discuss the general mechanisms of heat therapy on (LBP), and finally review the published evidence regarding the impact of superficial heat therapy in patients with acute or chronic non-specific LBP. This review demonstrates that continuous, low-level heat therapy provides pain relief, improves muscular strength, and increases flexibility. Therefore, this effective, safe, easy-to-use, and cost-effective non-pharmacological pain relief option is relevant for the management of non-specific mild or moderate low back pain in current clinical practice.

Management of Osteoarthritis: Expert Opinion on NSAIDs.

Osteoarthritis (OA) is a leading cause of disability among older adults worldwide. Treatment aims are to alleviate inflammatory pain and improve physical function through non-pharmacological and pharmacological interventions. Non-steroidal anti-inflammatory drugs (NSAIDs) are recommended as first-line therapy. However, selection is challenged by patient age, comorbidities and polypharmacy, and by the drug's benefit/risk balance, all of which together influence the risk of cardiovascular (CV), gastrointestinal (GI) and renal adverse events (AEs). While the efficacy profile of the various NSAIDs is delineated, the differences in their safety profile are not straightforward. This narrative review provides practical indications by a multidisciplinary Italian expert panel for general practitioners and specialists managing OA patients with chronic inflammatory pain; the goal is to maximize therapy efficacy while reducing untoward effects caused by inappropriate NSAID use. The discussion on the best approach to NSAIDs spanned the following topics: (1) patient evaluation: investigate pain origin, duration and components together with possible risk factors for CV, GI and renal AEs; (2) non-pharmacological interventions: the physiatrist provides a person-centered, holistic approach accounting for all patient aspects; (3) pharmacological interventions: patient profile and drugs' pharmacological properties affect NSAID selection, which drugs to be used in combination or to be avoided, formulation and therapy duration; (4) the pharmacologist's, general practitioner's and pain therapist's points of view; (5) NSAID safety: the individual baseline risk and the drug's safety profile are major determinants of CV, GI and renal risk; consider possible drug-drug interactions; (6) periodical re-evaluation of treatment response and adherence, using scales to assess pain and function.

Effectiveness of ibuprofen plus paracetamol combination on persistence of acute musculoskeletal disorders in primary care patients.

Background General practitioners often deal with patients suffering acute musculoskeletal disorders. Paracetamol, non-steroidal anti-inflammatory drugs, and opioids are the most prescribed medications, according to pain intensity and patient's features. Combinations of different analgesics can be adopted to enhance pain relief, but only one fixed-dose combination has been recently launched to treat acute musculoskeletal pain. Objective This study aimed to investigate the effectiveness of ibuprofen plus paracetamol (fixed-dose) combination compared to other analgesics in preventing musculoskeletal pain persistence. Setting Italian outpatients' data extracted from a national general practice database. Method A retrospective cohort study was conducted on the Health Search Database. Patients prescribed with analgesics for acute musculoskeletal painful conditions were considered (i.e., non-chronic painful conditions, identified using a query validated by two expert General Practitioners (GPs)). For each patient, the first prescription of an analgesic was defined as index date. A new GP's visit related to musculoskeletal disorders in the first 3 months following the index date was defined as "pain persistence". Main outcome measure Risk of pain persistence among users of the ibuprofen plus paracetamol combination compared to other systemic analgesics. Results Overall, 102,216 patients were treated with systemic analgesics for acute musculoskeletal disorders. Most patients were middle-aged or elderly women. 939 (0.92%) patients were prescribed with the fixed-dose ibuprofen plus paracetamol combination for a mean duration of 7.23 ± 2.68 days, mainly for low back pain and cervicalgia. Musculoskeletal pain persistence was found in 22,125 (21.65%) patients. Compared to other systemic analgesics, the ibuprofen plus paracetamol combination resulted significantly more effective in preventing pain persistence (adjusted hazard ratio 0.72, 95% confidence interval 0.61-0.85). Conclusion These findings suggest that the fixed-dose ibuprofen plus paracetamol combination might be effective in controlling musculoskeletal pain persistence.

Quality of life and functional outcomes with tapentadol prolonged release in chronic musculoskeletal pain: post hoc analysis.

Aims: To investigate quality of life (QOL) and functionality changes in chronic pain during tapentadol prolonged release (PR) treatment. Patients & methods: Post hoc analysis of data from three Phase III trials in patients with osteoarthritis knee pain or low back pain. QOL and functionality changes were assessed by SF-36 scores. Results: All SF-36 subdomain scores improved progressively to week 3 of tapentadol titration and were sustained during 12-week maintenance treatment. Improvements in SF-36 scores were similar between tapentadol dose groups (e.g., 200 to <300 mg vs ≥500 mg), with no greater effect from higher doses. QOL and functionality improvements were consistently greater with tapentadol PR than oxycodone controlled release. Conclusion: Tapentadol PR provides consistent, clinically relevant improvements in QOL and functionality in chronic pain.

Not All Pain is Created Equal: Basic Definitions and Diagnostic Work-Up.

Chronic pain is considered a public health priority by the World Health Organization and European health institutions. It has reached alarming proportions in terms of disability, consumption of health and social resources, and impact on primary and specialist care services. Primary care physicians are often called on to manage this condition. Chronic pain management can be challenging due to its complexity. It has traditionally been considered to include nociceptive pain that that persists longer than the normal healing time, neuropathic pain lasting more than 3 months, or a combination of these. More recently, a third descriptor, nociplastic (primary) pain, was added to classify patients with chronic pain conditions such as fibromyalgia, nonspecific back pain, or mixed pain that persists or other conditions in which altered central pain modulation results in central sensitization and chronic pain in the absence of actual or threatened damage to tissues, including in the somatosensory nervous system. This document provides an overview of pain types and their underlying mechanisms. Successful pain management is facilitated by identification of the pain type. A set of diagnostic tools and a pain algorithm are presented to guide the clinician toward the correct diagnosis. The algorithm identifies cases that may require referral to a pain specialist. Once the site of origin of the pain (the "pain generator") is identified, or a primary pain syndrome is suspected, the accompanying article provides information and rationale to support treatment decisions based on patient characteristics.

Pharmacological Management of Adults with Chronic Non-Cancer Pain in General Practice.

Chronic pain is a public health priority that affects about 20% of the general population, causing disability and impacting productivity and quality of life. It is often managed in the primary care setting. Chronic pain management is most effective when the pain mechanism has been identified and addressed by appropriate therapy. This document provides an overview of pharmacological therapy for chronic non-cancer pain in the primary care setting, with the aim of improving treatment decisions based on the underlying pain mechanisms and pain neuroscience.

Prescribing Trends of Codeine-containing Medications and Other Opioids in Primary Care After A Regulatory Decision: An Interrupted Time Series Analysis.

BACKGROUND AND OBJECTIVES: In 2014, the Italian Medicines Agency (AIFA) amended the summary of product characteristics of codeine-containing medications limiting their use for maximum three days. This study attempted to clarify the impact of AIFA intervention on prescribing trends and appropriateness of use of codeine-containing medications and other opioids. METHODS: Using the Health Search Database, a quasi-experimental interrupted time series analysis was conducted to evaluate changes in prescribing trends and appropriateness of use of codeine-containing medications and opioids between 2013 and 2015. RESULTS: Prescribing trends of codeine-containing medications significantly decreased (on average, - 352 days of treatment per month of observation), while long-acting opioids (LAOs) had an overall increase. Trends of inappropriate prescriptions significantly increased for two LAOs (i.e. tapentadol, naloxone-oxycodone), both before and after AIFA intervention. CONCLUSION: The use of paracetamol-codeine combination was effectively decreased in Italy because of AIFA intervention. Instead, prescriptions of tapentadol and oxycodone-naloxone stably increased over the study period irrespective of regulatory intervention. Given that the choice of the most appropriate opioid therapy is not straightforward, especially in elderly and/or comorbid patients, general practitioners should consider carefully alternative therapies on the bases of regulatory interventions.

Celiac disease with mild enteropathy is not mild disease.

BACKGROUND & AIMS: Patients with celiac disease have varying degrees of damage to the small intestinal mucosa, ranging from lymphocytic duodenosis with normal villous structure to severe villous atrophy. We assessed whether the severity of mucosal lesions was associated with clinical and laboratory features of celiac disease. METHODS: We compared demographic, clinical, and laboratory characteristics among patients with celiac disease who were classified based on the severity of duodenal lesions. We analyzed data from 1408 adult patients seen consecutively at a tertiary referral center since 1990. Patients were classified as having villous atrophy (n = 1249) or as having mild enteropathy (n = 159) in the presence or absence of villous atrophy. RESULTS: Similar percentages of patients with villous atrophy, vs mild enteropathy, experienced weight loss (17% vs 17%), gastrointestinal manifestations (70% vs 70%), extraintestinal manifestations (66% vs 57%), and other associated conditions (19% vs 23%). More patients with villous atrophy than patients with mild enteropathy developed osteopenia or osteoporosis (22% vs 5%; P = .0005). Greater percentages of patients with villous atrophy than those with mild enteropathy also had anemia (42% vs 29%; P = .002), folate deficiency (75% vs 64%; P = .02), hypocholesterolemia (7% vs 2%; P = .02), hypocalcemia (26% vs 13%; P = .004), or hyperparathyroidism (45% vs 29%; P = .004). CONCLUSIONS: Although osteopenia, osteoporosis, and alterations in laboratory parameters are prevalent among patients with celiac disease with mild enteropathy, they are more prevalent and severe in those with villous atrophy. The prevalence of associated conditions is similar between these groups. These results indicate that celiac disease with mild enteropathy is not mild disease, but requires treatment with a gluten-free diet.

Incidence of post-infectious irritable bowel syndrome and functional intestinal disorders following a water-borne viral gastroenteritis outbreak.

OBJECTIVES: Post-infectious irritable bowel syndrome (PI-IBS) may develop in 4-31% of affected patients following bacterial gastroenteritis (GE), but limited information is available on long-term outcome of viral GE. During summer 2009, a massive outbreak of viral GE associated with contamination of municipal drinking water (Norovirus) occurred in San Felice del Benaco (Lake Garda, Italy). To investigate the natural history of a community outbreak of viral GE, and to assess the incidence of PI-IBS and functional gastrointestinal disorders, we carried out a prospective population-based cohort study with a control group. METHODS: Baseline questionnaires were administered to the resident community within 1 month of the outbreak. Follow-up questionnaires of the Italian version of Gastrointestinal Symptom Rating Scale (GSRS, a 15-item survey scored according to a 7-point Likert scale) were mailed to all patients responding to baseline questionnaire at 3 and 6 months, and to a cohort of unaffected controls, living in the same geographical area, at 6 months after the outbreak. The GSRS item were grouped in five dimensions: abdominal pain, reflux, indigestion, diarrhea, and constipation. At month 12, all patients and controls were interviewed by a health assistant to verify Rome III criteria of IBS. Student's t-test and χ(2)- or Fisher's exact test were used as appropriate. RESULTS: Baseline questionnaires were returned by 348 patients: mean age ± s.d. 45 ± 22 years, 53% female. At outbreak, nausea (scored ≥4), vomiting, and diarrhea lasting 2-3 days or more were reported by 66, 60, and 77% of patients, respectively. A total of 50% reported fever and 19% reported weight loss (mean 3 kg). Follow-up surveys were returned at month 6 by 186 patients and 198 controls: mean GSRS score was significantly higher in patients than in controls for abdominal pain, diarrhea, and constipation. At month 12, we identified 40 patients with a new diagnosis of IBS (Rome III criteria), in comparison with 3 subjects in the control cohort (P<0.0001; odds ratio 11.40; 95% confidence intervals 3.44-37.82). The 40 cases of PI-IBS were subtyped according to the predominant stool pattern as follows: 4 IBS with constipation, 7 IBS with diarrhea, 16 with mixed IBS, and 13 with unsubtyped IBS. CONCLUSIONS: Our study provides evidence that Norovirus GE leads to the development of PI-IBS in a substantial proportion of patients (13%), similar to that reported after bacterial GE.

High tissue-transglutaminase antibody level predicts small intestinal villous atrophy in adult patients at high risk of celiac disease.

BACKGROUND: Duodenal biopsy may be unnecessary to confirm celiac disease in patients with high tissue-transglutaminase antibody level. AIMS: To define a cut-off value of tissue-transglutaminase antibody with high positive likelihood ratio for duodenal atrophy in patients with suspected celiac disease. METHODS: We retrospectively identified 945 patients with suspected celiac disease and classified according to the method used for tissue-transglutaminase antibody assay: Group A (n=393, Eu-tTG® Eurospital), Group B (n=263; Eu-tTG® Eurospital) and Group C (n=289; Celikey® Phadia). Duodenal histology was graded according to Marsh. Sensitivity, specificity, and positive likelihood ratio were used to evaluate cut-off points of tissue-transglutaminase antibody as predictor of villous atrophy. RESULTS: 100% specificity and ∞ positive likelihood ratio for duodenal atrophy was observed at a cut-off value of tissue-transglutaminase antibody 5 times higher than the upper limit of normal. CD diagnosis was confirmed by concordance with antiendomysial antibodies, and by reduction of t-TG titre in all patients and improvement of duodenal histology in 80% during gluten-free diet. CONCLUSIONS: Tissue-transglutaminase antibody level 5-folds the upper limit of normal is 100% specific for duodenal atrophy and using this cut-off biopsy could by avoided in 1/3 of patients. Diagnostic criteria of celiac disease in adults need revision.

Different effects of antihypertensive regimens based on fosinopril or hydrochlorothiazide with or without lipid lowering by pravastatin on progression of asymptomatic carotid atherosclerosis: principal results of PHYLLIS--a randomized double-blind trial.

BACKGROUND AND PURPOSE: The Plaque Hypertension Lipid-Lowering Italian Study (PHYLLIS) tested whether (1) the angiotensin-converting enzyme (ACE) inhibitor fosinopril (20 mg per day) was more effective on carotid atherosclerosis progression than the diuretic hydrochlorothiazide (25 mg per day), (2) pravastatin (40 mg per day) was more effective than placebo when added to either hydrochlorothiazide or fosinopril, and (3) there were additive effects of ACE inhibitor and lipid-lowering therapies. METHODS: A total of 508 hypertensive, hypercholesterolemic patients with asymptomatic carotid atherosclerosis were randomized to: (A) hydrochlorothiazide; (B) fosinopril; (C) hydrochlorothiazide plus pravastatin; and (D) fosinopril plus pravastatin, and followed up blindly for 2.6 years. B-Mode carotid scans were performed yearly by certified sonographers in 13 hospitals and read centrally. Corrections for drift were calculated from readings repeated at study end. Primary outcome was change in mean maximum intima-media thickness of far and near walls of common carotids and bifurcations bilaterally (CBM(max)). RESULTS: CBM(max) significantly progressed (0.010+/-0.004 mm per year; P=0.01) in group A (hydrochlorothiazide alone) but not in groups B, C, and D. CBM(max) changes in groups B, C, and D were significantly different from changes in group A. Changes in group A were concentrated at the bifurcations. "Clinic" and "ambulatory" blood pressure reductions were not significantly different between groups, but total and low-density lipoprotein cholesterol decreased by approximately 1 mmol/L in groups C and D. CONCLUSIONS: Progression of carotid atherosclerosis occurred with hydrochlorothiazide but not with fosinopril. Progression could also be avoided by associating pravastatin with hydrochlorothiazide.