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An international consensus on the etiology, risk factors, diagnosis and Management for individuals with Frozen Shoulder: a Delphi study

Salamh, Paul; Stoner, Brent; Ruley, Nathaniel; Zhu, Huiling; Bateman, Marcus; Chester, Rachel; Da Baets, Liesbet; Gibson, Jo; Hollmann, Luise; Kelley, Martin; Lewis, Jeremy; McClure, Philip; McCreesh, Karen; Mertens, Michel Gcam; Michener, Lori; Seitz, Amee L; Struyf, Filip; Zuckerman, Joseph; King, William
INTRODUCTION/UNASSIGNED:There has been an emergence of evidence in the area of frozen shoulder (FS) within the past decade related to risk factors, etiology, diagnosis, and management. It has become increasingly challenging for clinicians and researchers to stay up to date in these areas, particularly with the clinical practice guidelines that are available being few and outdated. To this end, the aim of this study was to produce an international consensus on the risk factors, etiology, diagnosis and management for individuals with FS. METHODS/UNASSIGNED:During phase one a steering committee was formed in order to identify experts in the area of FS, examine the current evidence related to FS and identify key areas lacking consensus. Phase two consisted of inviting experts to participate in a three-round survey with a priori consensus level set at 80%. Descriptive statistics were utilized to determine the characteristics of the expert panel, response rate, and level of consensus. RESULTS/UNASSIGNED:A total of 14 international experts responded to all three rounds of the Delphi survey with 100% response rate following round one. Consensus was reached for 101 items (57 in the first round, 37 in the second round and 7 in the third and final round). Specific to key topic areas, the following number of items reached consensus; etiology 9 items (diabetes mellitus, trauma, shoulder arthroscopy, thyroid disease, prolonged immobilization, adrenocorticotropic hormone deficiency, metabolic synderome, connective tissue disorders, and hyperlipidemia), risk factors 40 items (including biophysical factors for developing FS and biophysical and psychosocial factors influencing the Management and course of outcomes related to FS), diagnosis 19 items (4 confounding the diagnosis and 15 signs and symptoms associated with FS), Management 33 items overall and categorized into effectiveness for early and later stages of FS). CONCLUSION/UNASSIGNED:The results of this international Delphi study help to provide a consensus on key elements to consider in clinical practice related to etiology, risk factors, diagnosis, and management for those with FS.
PMID: 40042389
ISSN: 2042-6186
CID: 5820562

White blood cell concentration correlates with increased concentrations of IL-1ra and improvement in WOMAC pain scores in an open-label safety study of autologous protein solution

King, William; van der Weegen, Walter; Van Drumpt, Rogier; Soons, Hans; Toler, Krista; Woodell-May, Jennifer
BACKGROUND: There has been debate on which blood components should be included in autologous therapies. Autologous Protein Solution (APS) is a unique blood-derived therapy composed of concentrated white blood cells, platelets, and plasma to contain high concentrations of anti-inflammatory cytokines and anabolic growth factors to potentially address osteoarthritis. The primary aim of the exploratory secondary analysis was to identify characteristics of an Autologous Protein Solution (APS) that may correlate with improved Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores and OMERACT-OARSI responder status after treatment of subjects with an intra-articular injection of APS. METHODS: Eleven subjects were enrolled in a pilot study of a single intra-articular injection of APS in subjects with knee osteoarthritis. Two APS kits were processed per patient. The output of the first APS kit was injected intra-articularly. White blood cell (WBC) and cytokine concentrations were measured from the output of the second APS kit. WOMAC surveys were completed at baseline and at follow up visits. Linear regression analyses were performed on the blood components of APS with subject outcomes. Anderson-Darling analysis was used to determine whether the cytokine concentrations in whole blood and APS had a normal distribution. Either paired t-test analyses or Wilcoxon signed-rank analyses were performed for normal and non-parametrically distributed data, respectively. RESULTS: The WBC concentration in APS was significantly (p < 0.05) and strongly (R(2) > 0.7) correlated with IL-1ra in APS but not significantly correlated with IL-1beta. The ratio of IL-1ra to IL-1beta in APS was significantly correlated with improved WOMAC pain scores one week and six months post-injection. 85.7 % of subjects whose APS had a IL-1ra:IL-1beta ratio greater than 1000 or a WBC count greater than 30 k/mul were OMERACT-OARSI responders six months post-injection. CONCLUSIONS: The correlations between the IL-1ra:IL-1beta ratio and WBC concentration in a subject's APS and their WOMAC pain scores and classification as OMERACT-OARSI responders suggest the potential utility of these characteristics as diagnostic markers. Additional studies are ongoing to determine whether APS is safe and effective and to further evaluate the relationship between APS composition and clinical outcomes. TRIAL REGISTRATION: ( NCT01773226 ).
PMCID:4747972
PMID: 26915009
ISSN: 2197-1153
CID: 2127992