Prevalence of FMS Diagnosis According to ACR 2016 Revised Criteria in a Pain Therapy Centre in Italy: Observational Study.

Background and Objectives: Fibromyalgia syndrome (FMS) is a multifaceted disease with a strong preference for the female sex. It is characterised by chronic widespread pain, sleep-wake disorders, fatigue, cognitive disturbances, and several other somatic symptoms. Materials and Methods: In this prospective observational study, we analysed data regarding 302 patients who were referred to our pain centre for a first clinical assessment evaluation and were then inspected for the physician-based 2016 revision of the ACR diagnostic criteria for FMS, regardless of the final diagnosis previously made by the pain therapist. Results: Among the 280 patients who adhered to the 2016 ACR questionnaire, 20.3% displayed positive criteria for FMS diagnosis. The level of agreement between the FMS discharge diagnosis made by the pain clinician and the ACR 2016 criteria-positivity was moderate (kappa = 0.599, with moderate agreement set at a kappa value of 0.6). Only four patients (1.7%) diagnosed as suffering from FMS at discharge did not satisfy the minimal 2016 ACR diagnostic criteria. Conclusions: This prospective observational study confirmed the diagnostic challenge with FMS, as demonstrated by the moderate grade of agreement between the FMS diagnosis at discharge and the positivity for 2016 ACR criteria. In our opinion, the use of widely accepted diagnostic guidelines should be implemented in clinical scenarios and should become a common language among clinicians who evaluate and treat patients reporting widespread pain and FMS-suggestive symptoms. Further methodologically stronger studies will be necessary to validate our observation.

Epidemiological, pharmacological and sociodemographic characterisation of a population of 386 fibromyalgic patients referred to a tertiary pain centre in Italy.

Fibromyalgia's prevalence in Italy is about 4%. Apart from widespread pain and the three main conditions related to fibromyalgia that are included in its diagnosis (fatigue, unrefreshing sleep and cognitive disorders disturbances), there are a number of minor symptoms that have been associated to fibromyalgia. The current study aimed to characterise fibromyalgic patients referring to a single tertiary pain centre not only for sociodemographic data, but also with special attention on pharmacological history and "minor" symptoms. "Minor" refers to the group of symptoms that were frequently associated and reported with fibromyalgia in various epidemiological studies but are not required for diagnosis. A retrospective analysis was made on 386 patients with confirmed diagnosis based on the 2010 modified criteria. Our results partially confirmed known sociodemographic data, but the prevalence of some "minor" symptoms are impressively high in our population.

Evaluating driving abilities of patients under opioid treatment for chronic pain, by using the Vienna Test System and a newly released APP for smartphones (APP SafeDrive). The old and the new.

OBJECTIVE: The study compare two tests for evaluating the driving abilities of patients undergoing opioid therapy for chronic pain: the Vienna Test System (VTS), a software developed for this purpose, and a new free APP for smartphones (SafeDrive) measuring visual and auditory reaction times. METHODS: One hundred and five patients undergoing long term opioid therapy for chronic pain were enrolled. The driving abilities of study patients were evaluated using two tests, namely the Vienna test System (VTS) and the SafeDrive APP. The concordance between the two tests was evaluated through Cohen's test. In addition we evaluated the correlation between the results of both VTS and SafeDrive tests and prescribed Morphine Equivalent Doses (MEDs), sex, age and the specific drugs taken, by multivariate linear regression analysis. RESULTS: A statistically significant concordance (Cohen's K coefficient=0.476) was found between the SafeDrive APP and the VTS; multivariate linear regression analysis found no significant influences of dosage and type of opioid prescribed on test performances, but significant influences of sex and age. CONCLUSIONS: The Authors found a significant correlation between VTS with SafeDrive test results. The SafeDrive APP is cheaper, easier to use and faster than VTS, and is portable and "usable on the road". Complex behavioral tasks such as driving may be severely impaired by psychoactive drugs, and consequently SafeDrive could be considered a useful portable screening tool to identify drivers with drug associated psychomotor impairment.

Current trends in disability claims due to fibromyalgia syndrome.

Fibromyalgia syndrome (FMS) affects 0.4-8% of the general population predominantly in the female population with a F:M ratio of 3-9:1. It is characterised by persistent widespread pain and other associated clinical conditions such as chronic fatigue, irritable bowel syndrome (IBS), temporomandibular joint dysfunction (TMJD), sleep disorders and cognitive impairment. FMS diagnosis at present is purely clinical because no medical or laboratory examinations are able to identify it with certainty. FMS is not fully recognised worldwide, and patients often do not receive the treatment and disability benefits planned for other chronic diseases even though it gives rise to a very significant social burden due to direct and indirect healthcare costs and the loss of productivity and work. This article describes the medico-legal situation of FMS patients around the world, particularly issues related to the recognition of the disease by health institutions and the provision of disability benefits. We also discuss the current means of assessing disabilities in the medico-legal context, and their possible future improvements.

Suprascapular nerve block for the treatment of hemiplegic shoulder pain in patients with long-term chronic stroke: a pilot study.

Hemiplegic shoulder pain is the most common pain condition after stroke. Suprascapular nerve block is an effective treatment for shoulder pain. The aim of this pilot study was to evaluate the effects of suprascapular nerve block on pain intensity, spasticity, shoulder passive range of motion, and quality of life in long-term chronic stroke patients with hemiplegic shoulder pain. Ten chronic stroke patients (over 2 years from onset) with hemiplegic shoulder pain graded ≥30 mm on the Visual Analogue Scale underwent suprascapular nerve block injection with 1 mL of 40 mg/mL methylprednisolone and 10 mL 0.5% bupivacaine hydrochloride. Main outcome was the Visual Analogue Scale evaluated before and after nerve block at 1 h, 1 week, and 1 month. Secondary outcomes were the modified Ashworth scale and the shoulder elevation, abduction, and external rotation passive range of motion evaluated before the nerve block and after 1 h as well as the American Chronic Pain Association Quality of Life Scale evaluated before and after nerve block at 1 month. The Visual Analogue Scale significantly improved after nerve block at 1 h (P = 0.005) and 1 week (P = 0.011). Significant improvements were found at 1 h after nerve block in the modified Ashworth scale (P = 0.014) and the passive range of motion of shoulder abduction (P = 0.026), flexion (P = 0.007), and external rotation (P = 0.017). The American Chronic Pain Association Quality of Life Scale significantly improved at 1 month after nerve block (P = 0.046). Our findings support the use of suprascapular nerve block for treating hemiplegic shoulder pain in long-term chronic stroke patients.

Extended Treatment with Micron-Size Oral Palmitoylethanolamide (PEA) in Chronic Pain: A Systematic Review and Meta-Analysis.

Palmitoylethanolamide (PEA) emerged over the years as a promising approach in the management of chronic pain. Despite the fact that the efficacy of micron-size PEA formulations appears to be time-dependent, the optimal timing has not yet been elucidated. This systematic review and meta-analysis aim to estimate the possible advantage of an extended treatment in the relief of chronic pain. The literature search was conducted consulting scientific databases, to identify clinical trials in which micron-size PEA was administered for at least 60 days, and pain assessed by the Visual Analogue Scale (VAS) or Numeric Rating Scale (NRS). Nine studies matched the required criteria, for a total of 742 patients involved. The meta-analysis showed a statistically and clinically significant pain intensity reduction after 60 days of micron-size PEA supplementation, compared to 30 days (1.36 points, p < 0.01). The secondary analysis revealed a weighted NRS/VAS score decrease of 2.08 points within the first month of treatment. These two obtained scores corresponded to a 35.1% pain intensity reduction within the first month, followed by a further 35.4% during the second month. Overall, these results confirm the clinically relevant and time-depended pain-relieving effect of micron-size PEA and therefore the advantage of an extended treatment, especially in patient with incomplete pain management.

Anti-CGRP and Anti-CGRP Receptor Monoclonal Antibodies for Migraine Prophylaxis: Retrospective Observational Study on 209 Patients.

BACKGROUND: Migraine is a neurological disorder characterized by attacks of head pain with prevalent unilateral localization, moderate to high intensity and specifically associated accompanying symptoms. METHODS: In this retrospective observational study, we analyzed data regarding 209 patients who had previously been diagnosed with migraine and who were prescribed, between 2019 and 2022, subcutaneous injections of anti-CGRP monoclonal antibodies (mAbs) fremanezumab or galcanezumab or anti-CGRP receptors mAb erenumab regardless of the concomitant assumption of any other acute-phase or prophylactic migraine medication. RESULTS: Regarding efficacy, in the 205 analyzed patients, the change from baseline in terms of MIDAS, HIT-6, MMDs and MAD scores was statistically significant for erenumab and galcanezumab, while for fremanezumab a statistical significance was not achieved likely due to the small sample size. In the treated population, 36 patients (17.5%) reported AEs (pain during injection, transient injection site erythema, nausea, constipation and fatigue). Only 5 patients (2.4%) discontinued the treatment for AEs while 15 patients (7.3%) left for lack of efficacy. CONCLUSIONS: this retrospective study comes out in favor of both significant efficacy and safety of anti-CGRP and anti-CGRP receptors mAbs in migraine patients. Further methodologically stronger studies are necessary to validate our observation.

Persistent Idiopathic Facial Pain (PIFP) in Patients Referred to a Multidisciplinary Centre in Italy: A Retrospective Observational Study.

BACKGROUND: Persistent Idiopathic Facial Pain (PIFP), previously named Atypical Facial Pain (AFP) is a poorly understood condition, often diagnosed after several inconclusive investigations. The aim of this retrospective study was to evaluate the demographic and clinical characteristics of patients with PIFP referred to a Facial Pain Center. METHODS: Between May 2011 and September 2014, data on 41 PIFP patients were analyzed regarding temporal, topographical and descriptive pain features, including onset, localization, pain descriptors and intensity. Pharmacological pain treatments were also registered. Finally, the presence and type of previous minor oro-surgery procedures in the painful area were investigated. RESULTS: Demographic and clinical characterization were similar to PIFP patients reported in literature. The presence of previous minor oro-surgery procedures in the painful area was reported in most of these patients, in particular endodontic treatments and tooth extractions. CONCLUSIONS: This retrospective analysis showed a high prevalence of minor oro-surgery procedures in our population, while its role in PIFP pathophysiology remains unknown. A new classification of PIFP built around the main discriminant factor of presence of these procedures in the painful area could be considered while available data were still insufficient to define specific diagnostic criteria.

Bipolar Spectrum Symptoms in Patients with Fibromyalgia: A Dimensional Psychometric Evaluation of 120 Patients.

BACKGROUND: Fibromyalgia Syndrome (FMS) is characterized by chronic widespread pain, fatigue, unrefreshing sleep and cognitive dysfunction. Depressive and manic symptoms are often reported in FMS patients' history. The aim of this study was to evaluate the prevalence of bipolar spectrum symptoms (BSS) and to correlate these with quality of life (QoL) scores and antidepressant treatment. METHODS: From October 2017 to July 2018, a battery of QoL questionnaires (FIQ, PSQI and SF-12) was administered to 120 FMS patients after a clinical examination. The MOODS-SR lifetime questionnaire was then remotely administered to the patients included in the study. RESULTS: The presence of depressive and manic lifetime symptoms was found, in line with the results of the available literature. A correlation was found between the history of depressive symptoms and the severity of FIQ and SF-12 scores. Despite a low statistical strength, a trend toward a correlation between a history of manic symptoms and SNRI treatment was detected. CONCLUSIONS: The correlation between the MOOD-depressive domains and poor QoL is in line with the available literature. Further studies are needed to corroborate these findings and to elucidate the relationship between manic symptoms and SNRI treatment.

Oxycodone-Naloxone Combination Hinders Opioid Consumption in Osteoarthritic Chronic Low Back Pain: A Retrospective Study with Two Years of Follow-Up.

Chronic low back pain (CLBP) due to osteoarthritis represents a therapeutic challenge worldwide. Opioids are extensively used to treat such pain, but the development of tolerance, i.e., less susceptibility to the effects of the opioid, which can result in a need for higher doses to achieve the same analgesic effect, may limit their use. Animal models suggest that ultra-low doses of opioid antagonists combined with opioid agonists can decrease or block the development of opioid tolerance. In this retrospective study, we tested this hypothesis in humans. In 2019, 53 patients suffering from CLBP were treated with either Oxycodone and Naloxone Prolonged Release (27 patients, OXN patients) or Oxycodone Controlled Release (26 patients, OXY patients). The follow-up period lasted 2 years, during which 10 patients discontinued the treatment, 5 out of each group. The remaining 43 patients reached and maintained the targeted pain relief, but at 18 and 24 months, the OXY patients showed a significantly higher oxycodone consumption than OXN patients to reach the same level of pain relief. No cases of respiratory depression or opioid abuse were reported. There were no significant differences in the incidence of adverse effects between the two treatments, except for constipation, more common in OXY patients. From our results, we can affirm that a long-term opioid treatment with oxycodone-naloxone combination, when compared with oxycodone only, may significantly hinder the development of opioid tolerance. We were also able to confirm, in our cohort, the well known positive effect of naloxone in terms of opioid-induced bowel dysfunction incidence reduction.

Perioperative Fluid Administration in Pancreatic Surgery: a Comparison of Three Regimens.

BACKGROUND: Optimization of perioperative fluid management is a controversial issue. Weight-adjusted, fixed fluid strategies do not take into account patient hemodynamic status, so that individualized strategies guided by relevant variables may be preferable. We studied this issue in patients undergoing pancreatic surgery within our institution. METHODS: All patients who underwent a laparotomy for pancreatic cancer during a 5-month period at our hospital (AOUI of Verona, Italy) were eligible to be included in this prospective, observational study. According to the responsible anesthesiologist's free choice, patients received, during surgery, either liberal (12 ml/kg/h) or restricted (4 ml/kg/h) fixed-volume weight-guided replacement fluids or goal-directed (GD) fluid replacement using stroke volume variation (SVV) determined by the FloTrac Vigileo device. RESULTS: Eighty-six patients were included: 29 in the liberal group, 23 in the restricted group, and 34 in the GD group. The mean duration of surgery was 6 [4-7] h. Patients in the liberal group received more perioperative fluid than those in the GD and restricted groups. Nearly one third of all patients had a major complication, including delayed enteral feeding, and presented a longer duration of hospital stay. Despite the biases related to our limited cohort, there were significantly fewer postoperative complications (such as postoperative fistula, abdominal collection, and hemorrhage) in the restricted and GD groups of patients than in the liberal one. CONCLUSION: In patients undergoing pancreatic surgery, a restricted or individually guided GD strategy for management of perioperative fluids can result in fewer complications than a liberal fluid strategy. Larger and randomized investigations are warranted to confirm these data on this domain.

Comparison between Acupuncture and Nutraceutical Treatment with Migratens® in Patients with Fibromyalgia Syndrome: A Prospective Randomized Clinical Trial.

OBJECTIVES: Fibromyalgia syndrome (FMS) is a chronic clinical condition characterized by pain, fatigue, altered sleep, and cognitive disturbances. The purpose of this study was to compare two alternative treatments (nutraceutical and acupuncture) in FMS patients through a randomized clinical trial. RESEARCH METHODS: A total of 60 FMS female patients were randomized for treatment with a nutritional combination containing coenzyme Q10, vitamin D, alpha-lipoic acid, magnesium, and tryptophan (Migratens® Group) or acupuncture treatment (Acupuncture Group) performed according the principles of traditional Chinese medicine (TCM), both for 3 months. Changes in pain and in quality of life (QoL) measured with a Fibromyalgia Impact Questionnaire Score-Revised (FIQ-R) and the Fibromyalgia Severity Scale (FSS) were performed at 1, 3, and 6 months after the start of treatments. RESULTS: A total of 55 patient completed the study (21 in the Migratens® Group and 34 in the Acupuncture Group). Migratens® treatment shows a statistically significant reduction of pain 1 month after the start of therapy (T1, p = 0.025), strengthened after 3 months with maintenance of treatment (p = 0.012). The efficacy in reducing pain was apparent in the Acupuncture Group at all post-treatment determinations and at follow-up (T1 and T2 p = <0.001). Regarding QoL, improvement in FIQ-R and FSS values was revealed in both groups. CONCLUSION: The nutraceutical approach with Migratens® seems to be an effective option to for patients with FMS. Our experience confirmed also the validity of acupuncture in these patients. Considering the complexity of the management of FMS patients, our results suggest a cyclical and sequential, or even concurrent treatment with different approaches, to improve the efficacy and the compliance of patients to long-term treatment.

Ultramicronized Palmitoylethanolamide (um-PEA) as Add-on Treatment in Fibromyalgia Syndrome (FMS): Retrospective Observational Study on 407 Patients.

BACKGROUND: Fibromyalgia syndrome is a chronic multifaceted disease characterized by widespread pain, muscle stiffness, fatigue, unrefreshing sleep and cognitive disorders. To date, no medication has been shown to significantly improve pain, associated symptoms and Quality of Life in fibromyalgic patients. METHODS: In this retrospective observational study, we analyzed data regarding 407 patients with diagnosis of fibromyalgia syndrome who between 2013 and 2016 have been prescribed orally ultramicronized palmitoylethanolamide tablets (Normast® Epitech Group SpA, Saccolongo, Italy) regardless of the concomitant pharmacological therapy (add-on treatment). RESULTS: Regarding efficacy, in the 359 analyzed patients, the change over time in Visual Analogue Scale pain score was statistically significant, ranging from 75.84 (±15.15) to 52.49 (±16.73) (p<0.001). Regarding quality of life, the change over time in Fibromyalgia Impact Questionnaire score was statistically significant, ranging from 68.4 (±14.1) to 49.1 (±19.6) (p<0.001). In the treated population, only 36 patients (13,7%) reported Adverse Events predominantly of gastrointestinal type (diarrhea, dyspepsia, bloating, constipation, vomiting). Globally, 151 patients (57,63%) left the treatment due to inefficacy. CONCLUSION: The results of ultramicronized palmitoylethanolamide treatment in this retrospective analysis represent an important step for the development of a new and well-tolerated therapy for fibromyalgia syndrome, mostly suitable for these patients who need long-term treatments. Further methodologically stronger studies will be necessary to validate our observation.

Efficacy of lidocaine 5% medicated plaster (VERSATIS®) in patients with localized neuropathic pain poorly responsive to pharmacological therapy.

BACKGROUND: Localized neuropathic pain (LNP) is a subgroup of neuropathic pain characterized by consistent and circumscribed area(s) of maximum pain, associated with negative or positive sensory signs and/or spontaneous symptoms characteristic of NP. Lidocaine medicated plasters (LMP) have shown to be effective in pain relief in selective LNP syndromes. METHODS: We collected data of 130 patients in our database with LNP syndromes who used LMP. RESULTS: Forty-one patients out of 130 patients (32%) were treated with antiepileptics, antidepressants and opioids without improvement and/or with intolerable adverse effects and are not assuming systemic therapy anymore. Globally, during the 12 months follow-up, 15% of patients reached a complete pain relief without any systemic therapy, mainly in trigeminal and post-herpetic neuralgia (P=0.009), 38% of patients reduced analgesic drug consumption with the highest reduction in radiculopathy, post-herpetic neuralgia and trigeminal neuralgia. Topical and transient adverse effects, such as itching or local erythema, were seen in 19/130 (14.6%) patients; 7 of these patients (5.4%) needed to discontinue the treatment due to the occurrence of adverse effects. The dropout rate on global population (excluding cured and lost to follow-up) was 45%, and the main cause of dropouts was the inefficacy of treatment in the first 3 months of therapy with LMP. CONCLUSIONS: LMP treatment is safe and worth consideration also as add-on therapy in order to reduce analgesic drug consumption in selected LNP.

A retrospective case series of ultrasound-guided suprascapular nerve pulsed radiofrequency treatment for hemiplegic shoulder pain in patients with chronic stroke.

PURPOSE: Hemiplegic shoulder pain (HSP) is the most common pain condition after stroke. Pulsed radiofrequency (PRF) treatment of the suprascapular nerve (SSN) effectively relieves shoulder pain conditions. To date, there is no study about the effects of PRF treatment for HSP. Thus, our aim was to report on a case series about its use in chronic stroke. PATIENTS AND METHODS: Six chronic stroke patients with HSP (visual analog scale [VAS] score for pain ≥30 mm) underwent ultrasound-guided SSN PRF treatment. All were evaluated before treatment and at 4 and 16 weeks of follow-up. The main outcome was VAS score. Secondary outcomes were Modified Ashworth Scale, shoulder passive range of motion (PROM), Disability Assessment Scale (DAS), Fugl-Meyer Assessment, and EuroQol-5 dimension questionnaire (EuroQol-5D) scores. RESULTS: As compared with baseline, improvement was observed in the following parameters: VAS for pain (at 4 weeks, P=0.023; at 16 weeks, P=0.023); shoulder PROM for abduction (at 4 weeks, P=0.023; at 16 weeks, P=0.024), flexion (at 4 and 16 weeks, P=0.024), extension (at 4 and 16 weeks, P=0.02), and external rotation (4 and 16 weeks, P=0.02); DAS for hygiene (at 4 and 16 weeks, P=0.024), dressing (at 4 weeks, P=0.02; at 16 weeks, P=0.024), and pain (at 4 weeks, P=0.024; at 16 weeks, P=0.023); and EuroQol-5D (at 4 and 16 weeks, P=0.024). CONCLUSION: Our observations support the use of ultrasound-guided SSN PRF treatment for HSP in chronic stroke patients.

Procalcitonin levels in surgical patients at risk of candidemia.

OBJECTIVE: Although the majority of cases of sepsis in intensive care unit (ICU) patients are due to bacterial infection, fungal infections are common and their early identification is important so that appropriate treatment can be started. Biomarkers have been used to aid diagnosis of bacterial infections, but their role in fungal infections is less defined. In this study we assessed the value of procalcitonin (PCT) levels for the diagnosis of candidemia or bacteremia in septic patients. METHODS: We prospectively recorded PCT levels in 48 critically ill surgical patients with signs of sepsis and at high risk for fungal infection, and compared levels in patients with candidemia and bacteremia. RESULTS: Bacterial species were isolated from blood cultures in 16 patients, Candida species in 17, and mixed bacterial and Candida species in 2 patients. PCT levels were less elevated in patients with candidemia (median 0.71 [IQR 0.5-1.1]) than in those with bacteremia (12.9 [2.6-81.2]). A PCT value less than 2 ng/ml enabled bacteremia to be ruled out with a negative predictive value of 94%, and had a similar positive predictive value for candidemia. CONCLUSIONS: Our data indicate that a low PCT value in a critically ill septic patient is more likely to be related to candidemia than to bacteremia.

A prospective evaluation of the Infection Probability Score (IPS) in the intensive care unit.

OBJECTIVES: Identification of infection remains a major challenge, particularly in acutely ill patients. The Infection Probability Score (IPS) was developed to help rule out infection in acutely ill patients. In the present study, we determined the IPS in acutely ill, intensive care unit (ICU) patients to assess its use in the diagnosis and treatment of infection. METHODS: In this prospective, observational study, we enrolled 107 consecutive patients who were admitted to the ICU without antibiotic therapy. Patients were allocated to four groups according to the probability of infection determined from clinical and microbiological data and their IPS values were then evaluated daily throughout the ICU stay. RESULTS: The IPS was higher in patients with the highest clinical probability of infection and decreased significantly in these patients after 5 days of effective antimicrobial therapy. The IPS remained below the cut-off value in non-infected patients. Patients in whom inadequate antimicrobial therapy was administered had a greater mortality than the other patients. CONCLUSIONS: The IPS had a good predictive value for diagnosis of infection. In addition, dynamic evaluation of this score may help to assess the response to therapy.