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.

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.

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.

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.

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.

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.