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Background Fibromyalgia (FM) is a complex chronic pain disorder characterized by widespread musculoskeletal pain and symptoms suggesting autonomic dysfunction. Small fiber neuropathy (SFN) has been described in a subgroup of patients. We aimed to explore the value of structured symptom assessment to identify patients with SFN or autonomic neuropathy. Methods Forty‐six female FM patients were assessed in a cross‐sectional study including clinical examinations, validated questionnaires (modified neuropathic pain symptom inventory (m‐NPSI), PainDETECT and the composite autonomic symptom score (COMPASS 31)) and diagnostic tests (intraepidermal nerve fiber density (IENFD), quantitative sensory testing (QST) and quantitative sudomotor axon reflex test (QSART)). m‐NPSI > 58, PainDETECT > 18, and COMPASS 31 > 16 were defined as suggestive of neuropathic pain and dysautonomia, respectively. SFN was defined as negative findings (hypoalgesia and reduced thermal sensation) and an abnormal diagnostic test (IENFD, thermal detection thresholds or QSART). Cardiovascular autonomic neuropathy (CAN) was defined as two abnormal cardiovascular reflex tests. Symptom scores were compared with patient controls and patients with an established diagnosis of neuropathy. Results Among FM patients, one had SFN, while two had definite CAN. Thirty‐two, 20, and 43 of the FM patients had NPSI, PainDETECT, and COMPASS 31 scores suggesting neuropathy/dysautonomia. NPSI was higher in FM than in neuropathy patients. Increased mechanical pain sensitivity (15/46) and paradoxical heat sensation (23/46) were frequent QST findings in the FM group. Conclusion SFN or autonomic neuropathy was infrequent in FM patients and not related to symptom scores, which were higher than those for patients with neuropathy.

Increasing recognition of chronic pain diseases, including Fibromyalgia, warrants the need for tools to monitor the impact of the disease as well as the efficacy of interventions. The Revised Fibromyalgia Impact Questionnaire (FIQR) has previously proved to be a valuable tool in both clinical and research settings. The study objective was to translate and validate the FIQR in Danish. A forward/backward translation, following the WHO-guidelines, was used to develop the Danish version of FIQR. The Danish translation of FIQR was answered by 101 patients suffering from fibromyalgia. The patients simultaneously answered the Hospital Anxiety and Depression Scale (HADS) and the 36-Item Short-Form Health Survey (SF-36) for validation. The Danish FIQR showed excellent internal consistency, and reliability with Interclass Correlation Coefficients above 0.9. The correlations to HADS and SF-36 ranged from fair to very good. All results were found to have a p-value <0.05. The present version of the Danish FIQR presents a valid and reliable tool for monitoring the impact of fibromyalgia.

Background Low-dose naltrexone (LDN) is used widely as an off-label treatment for pain despite limited evidence for its effectiveness. A few small trials with a high risk of bias have investigated the effect of LDN on pain associated with fibromyalgia in women, but larger and more methodologically robust studies are needed. The primary aim of this randomized controlled trial is to investigate if 12 weeks of LDN treatment is superior to placebo in reducing the average pain intensity during the last 7 days in women with fibromyalgia. Methods A single-center, permuted block randomized, double-blind, placebo-controlled, parallel-group trial will be performed in Denmark. Randomization comprises 100 women aged 18–64 years diagnosed with fibromyalgia who will be treated with either LDN or placebo for 12 weeks including a 4-week titration phase. The primary outcome is change in average pain intensity (during the last 7 days) from baseline to 12 weeks. Secondary outcomes are other fibromyalgia-related symptoms, i.e., tenderness, fatigue, sleep disturbance, stiffness, memory problems, depression, anxiety and measures of global assessment, physical function, impact of fibromyalgia, pain distribution, and health-related quality of life. Intention-to-treat analysis will be performed, and the number of responders with a more than 15%, 30%, and 50% improvement of pain after 12 weeks will be calculated for the LDN and placebo groups. Exploratory outcomes include measures of pain sensitivity, muscle performance, and biomarkers. Discussion This study will contribute with high-level evidence on the efficacy of low-dose naltrexone for the treatment of pain in women with fibromyalgia. Secondary outcomes include both disease-specific and generic components investigating whether LDN influences other symptoms than pain. Explorative outcomes are included to provide greater insight into the mechanism of action of LDN and possibly a better understanding of the underlying pathology in fibromyalgia. Trial registration EudraCT 2019-000702-30. Registered on 12 July 2019. ClinicalTrials.gov NCT04270877. Registered on 17 February 2020

PurposeTo assess long-term outcomes of restrictive versus standard intravenous (IV) fluid therapy in adult intensive care unit (ICU) patients with septic shock included in the European Conservative versus Liberal Approach to Fluid Therapy in Septic Shock in Intensive Care (CLASSIC) trial.MethodsWe conducted the pre-planned analyses of mortality, health-related quality of life (HRQoL) using EuroQol (EQ)-5D-5L index values and EQ visual analogue scale (VAS), and cognitive function using Mini Montreal Cognitive Assessment (Mini MoCA) test at 1 year. Deceased patients were assigned numerical zero for HRQoL as a state equal to death and zero for cognitive function outcomes as worst possible score, and we used multiple imputation for missing data on HRQoL and cognitive function.ResultsAmong 1554 randomized patients, we obtained 1-year data on mortality in 97.9% of patients, HRQoL in 91.3%, and cognitive function in 86.3%. One-year mortality was 385/746 (51.3%) in the restrictive-fluid group versus 383/767 (49.9%) in the standard-fluid group, absolute risk difference 1.5%-points [99% confidence interval (CI) − 4.8 to 7.8]. Mean differences were 0.00 (99% CI − 0.06 to 0.05) for EQ-5D-5L index values, − 0.65 for EQ VAS (− 5.40 to 4.08), and − 0.14 for Mini MoCA (− 1.59 to 1.14) for the restrictive-fluid group versus the standard-fluid group. The results for survivors only were similar in both groups.ConclusionsAmong adult ICU patients with septic shock, restrictive versus standard IV fluid therapy resulted in similar survival, HRQoL, and cognitive function at 1 year, but clinically important differences could not be ruled out.