Fibromyalgia is a common chronic pain condition that has a significant impact on quality of life and often leads to disability. To date, there have been few well-controlled trials assessing the utility of nonpharmacological treatment modalities such as transcutaneous electrical nerve stimulation (TENS) in the management of pain and improvement in function in individuals with fibromyalgia.The purpose of this study will be to complete a long-term, multicenter study to assess the effects of TENS in women with fibromyalgia.This will be a phase II randomized, double-blind, placebo-controlled, multicenter clinical trial.Three hundred forty-three participants with fibromyalgia will be recruited for this study.Participants will be randomly assigned to 1 of 3 groups: the intervention (TENS), placebo, or no treatment. After completing the randomized period, all participants will receive the intervention for 1 month. The participants will be asked to use TENS at the highest tolerable level for at least 2 hours daily during physical activity.The primary outcome will be pain with movement, with secondary outcomes assessing functional abilities, patient-reported outcomes, and quantitative sensory testing.Because having participants refrain from their typical medications is not practical, their usage and any change in medication use will be recorded.The results of this study will provide some of the first evidence from a large-scale, double-blind, placebo-controlled trial on the effectiveness of TENS on pain control and quality-of-life changes in patients with fibromyalgia.
Abstract Objective In evaluating the effectiveness of fibromyalgia (FM) therapies, it is important to assess the impact of those therapies on the full array of domains considered important by both clinicians and patients. The objective of this research was to identify and prioritize the key clinically relevant and important domains impacted by FM that should be evaluated by outcome assessment instruments used in FM clinical trials, and to approach consensus among clinicians and patients on the priority of those domains to be assessed in clinical care and research. Methods Group consensus was achieved using the Delphi method, a structured process of consensus building via questionnaires together with systematic and controlled opinion feedback. The Delphi exercises involved 23 clinicians with expertise in FM and 100 patients with FM as defined by American College of Rheumatology criteria. Results The Delphi exercise revealed that the domains ranked most highly by patients were similar to the domain rankings by clinicians. Pain was consistently ranked highest by both panels. Fatigue, impact on sleep, health‐related quality of life, comorbid depression, and cognitive difficulty were also ranked highly. Stiffness was ranked highly by patients but not clinicians. In contrast, side effects was important to clinicians but was not identified as important in the patient Delphi exercise. Conclusion The clinician and patient Delphi exercises identified and ranked key domains that need to be assessed in FM research. Based on these results, a conceptual framework for measuring patient‐reported outcomes is proposed.
Objective Sleep quality and duration are important for biological restoration and promotion of psychological well-being. Optimism may facilitate or result from sufficient sleep, but questions remain as to directionality. The present study tested how optimism is associated with levels of and variability in sleep quantity and quality in a longitudinal burst design. Methods Midlife and older women ( N = 199) reported their sleep quantity and quality in online diaries for a 7-day period, every 3 months for 2 years. Optimism was measured at baseline and end-of-study. Multilevel models tested the effects of optimism on sleep. Linear regression models tested the effect of sleep on optimism. Results Baseline optimism was associated with higher sleep quality ( γ = 2.13 [1.16 to 3.11], p < .0001) and lower intraindividual variability (IIV; night-to-night and wave-to-wave) in sleep quantity (night-to-night: γ = −0.07 [−0.13 to −0.005], p = .03; wave-to-wave: b = −0.07 [−0.12 to −0.02], p = .003). In turn, higher average sleep quality (but not quantity) was associated with higher optimism at end-of-study ( b = 0.02 [0.007 to 0.03], p = .002). Variability in sleep was unrelated to optimism. Conclusions Optimism may play an important role in maintaining sleep quality and consistency in sleep quantity, perhaps by buffering stress. Similarly, sleep quality may play an important role in maintaining optimism. The cycle whereby optimism and sleep enhance one another could improve physical health and psychological well-being among aging adults.
Researchers studying fibromyalgia strive to identify objective, measurable biomarkers that may identify susceptible individuals, may facilitate diagnosis, or that parallel activity of the disease. Candidate objective measures range from sophisticated functional neuroimaging to office-ready measures of the pressure pain threshold. A systematic literature review was completed to assess highly investigated, objective measures used in fibromyalgia studies. To date, only experimental pain testing has been shown to coincide with improvements in clinical status in a longitudinal study. Concerted efforts to systematically evaluate additional objective measures in research trials will be vital for ongoing progress in outcome research and translation into clinical practice.
Background: Clinicians are increasingly aware of the association of anti-neutrophil cytoplasmic antibody (ANCA) and interstitial lung disease (ILD), with or without a diagnosis of ANCA-associated vasculitis (AAV).The aim of this study was to evaluate the clinical characteristics and outcomes of patients with ILD with associated ANCA at Vanderbilt University Medical Center.Methods: The Vanderbilt Synthetic Derivative, the de-identified medical record, was queried for case records with abnormal ANCA lab value and interstitial lung disease by International Classification of Diseases, Ninth and Tenth Revisions (ICD9: 515, 515.31;ICD10 J84.112, J84.10) between January 2006 and July 2018.Clinical characteristics, diagnosis of concomitant rheumatic disease including AAV, pulmonary function, imaging data, and outcomes were abstracted from the case records.Results: Sixteen patients were identified.Most were Caucasian (94%) and female (56%).Median age at first ILD ICD9 or ICD10 code was 63.5 years old (range 36-80).Mean length of follow up was 4.6 years from diagnosis of ILD.Myeloperoxidase and perinuclear ANCA specificity were most common (n ¼ 10).Seven patients carried formal diagnoses of ANCA-associated vasculitis (6 microscopic polyangiitis, 1 granulomatosis with polyangiitis).In 4 patients, the ILD was a presenting manifestation of the AAV, while the ILD diagnosis preceded the AAV diagnosis by at least 3 months in 3 patients.Five patients had rheumatoid factor (RF) elevated greater than two times upper limits of normal, without a diagnosis of rheumatoid arthritis.Four patients had non-AAV autoimmune diagnoses, including two patients with inflammatory bowel disease, one patient with systemic sclerosis, and one patient with dermatomyositis.Imaging, histology, and treatments received in all patients are detailed in Table 1.Most patients (n ¼ 10) were prescribed home oxygen at some point in their course.Overall one-year mortality was 25%; nine patients had died by last follow up.Conclusion: Outcomes were poor in this population of patients with ANCA and ILD.Treatment approaches were varied at our institution.Interestingly, elevated RF and concomitant diagnosis of autoimmune diagnosis (other than AAV) were demonstrated in this cohort.These relationships should be evaluated in prospective cohort studies.
The Advances in Targeted Therapies meets annually, convening experts in the field of rheumatology to both provide scientific updates and identify existing scientific gaps within the field. To review the major unmet scientific needs in rheumatology. The 23rd annual Advances in Targeted Therapies meeting convened with more than 100 international basic scientists and clinical researchers in rheumatology, immunology, infectious diseases, epidemiology, molecular biology and other specialties relating to all aspects of immune-mediated inflammatory diseases. We held breakout sessions in five rheumatological disease-specific groups including: rheumatoid arthritis (RA), psoriatic arthritis (PsA), axial spondyloarthritis (axSpa), systemic lupus erythematosus (SLE), systemic sclerosis (SSc) and vasculitis, and osteoarthritis (OA). In each group, experts were asked to identify and prioritise current unmet needs in clinical and translational research. An overarching theme across all disease states is the continued need for clinical trial design innovation with regard to therapeutics, endpoint and disease endotypes. Within RA, unmet needs comprise molecular classification of disease pathogenesis and activity, pre-/early RA strategies, more refined pain profiling and innovative trials designs to deliver on precision medicine. Continued scientific questions within
