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      Clostridium histolyticum (AA4500) for the Treatment of Adhesive Capsulitis of the Shoulder: A Randomised Double-Blind, Placebo-Controlled Study for the Safety and Efficacy of Collagenase – Single Site Report

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          Abstract

          Background/Hypothesis

          Adhesive capsulitis of the shoulder results in pain and restricted movement of the glenohumeral joint. Hypothesis: There would be a difference in active range of movement in the affected shoulder of patients with adhesive capsulitis after receiving a series of injections of collagenase Clostridium histolyticum (CCH) compared to placebo.

          Methods

          This study reports the results from a single site that was part of a 321-participant, multicenter, double-blind, prospective parallel-group, randomized controlled clinical trial. Inclusion criteria: over 18 years of age, unilateral idiopathic adhesive capsulitis for >3 months, but <12 months. Exclusion criteria: recent physical therapy, injections, subacromial impingement, calcific tendonitis or glenohumeral joint arthritis in the affected shoulder. Subjects were randomized 3:1 to receive CCH 0.58 mg or placebo under ultrasound guidance. Injections were on days 1, 22, and 43. The primary outcome measure was a functional assessment of active range of movement.

          Results

          Overall, 37 patients were screened, 26 subjects were excluded, and 11 subjects were randomly assigned to the treatment group (n=9) or the control group (n=2). Both control and treatment groups showed improvement in ROM between baseline and day 95. In the treatment group, AROM improved from the baseline of 272.89° (SD 86.25) to 462.11° (SD 96.89) and the control group from 246.00° (SD 5.66) to 451.50° (SD 50.20) at day 95 with no statistical difference between groups p=0.78. Site data were in line with the whole study findings. Treatment-related adverse events at the injection site, including haematoma (bruising) and localised pain and swelling, were common.

          Conclusion

          Although the participants showed improvement in function, statistical significance was neither reached in the site nor the overall study cohort. Given the adverse events and the potential risks of the procedure, we would not recommend this drug for the treatment of adhesive capsulitis of the shoulder.

          Level of Evidence

          2, cohort from one site of RCT.

          Related collections

          Most cited references 13

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          Diagnosis and management of adhesive capsulitis

          Adhesive capsulitis is a musculoskeletal condition that has a disabling capability. This review discusses the diagnosis and both operative and nonoperative management of this shoulder condition that causes significant morbidity. Issues related to medications, rehabilitation, and post surgical considerations are discussed.
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            Adhesive capsulitis of the shoulder: review of pathophysiology and current clinical treatments.

             Hai Le (corresponding) ,  Stella Lee,  Ara Nazarian (2017)
            Adhesive shoulder capsulitis, or arthrofibrosis, describes a pathological process in which the body forms excessive scar tissue or adhesions across the glenohumeral joint, leading to pain, stiffness and dysfunction. It is a debilitating condition that can occur spontaneously (primary or idiopathic adhesive capsulitis) or following shoulder surgery or trauma (secondary adhesive capsulitis). Here, we review the pathophysiology of adhesive shoulder capsulitis, highlighting its clinical presentation, natural history, risk factors, pathoanatomy and pathogenesis. Both current non-operative and operative treatments for adhesive capsulitis are described, and evidence-based studies are presented in support for or against each corresponding treatment. Finally, the review also provides an update on the gene expression profile of adhesive capsulitis and how this new understanding can help facilitate development of novel pharmacological therapies.
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              Evaluation of Adhesive Capsulitis of the Shoulder With Fat-Suppressed T2-Weighted MRI: Association Between Clinical Features and MRI Findings

              The purpose of this study was to examine the association between clinical features and MRI findings in adhesive capsulitis of the shoulder.
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                Author and article information

                Journal
                Drug Des Devel Ther
                Drug Des Devel Ther
                DDDT
                dddt
                Drug Design, Development and Therapy
                Dove
                1177-8881
                10 July 2020
                2020
                : 14
                : 2707-2713
                Affiliations
                [1 ]Centre for Health and Exercise Sports Medicine, School of Health Sciences, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne , Parkville, VIC, Australia
                [2 ]Joint Health Institute , Melbourne, VIC, Australia
                [3 ]Medical School, College of Health and Medicine, Australian National University , Acton, ACT, Australia
                [4 ]Orthopaedic Surgery Department, School of Medicine, Pontifical Catholic University of Chile , Santiago, Chile
                Author notes
                Correspondence: Jane Fitzpatrick Centre for Health and Exercise Sports Medicine, School of Health Sciences, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne , Level 7, Allan Gilbert Building, 161 Barry Street, Melbourne, VIC, Australia Email jane.fitzpatrick@unimelb.edu.au
                Article
                259228
                10.2147/DDDT.S259228
                7360415
                © 2020 Fitzpatrick et al.

                This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms ( https://www.dovepress.com/terms.php).

                Page count
                Figures: 1, Tables: 3, References: 16, Pages: 7
                Funding
                Funding was received for this study from Auxilium Pharmaceuticals USA.
                Categories
                Original Research

                Pharmacology & Pharmaceutical medicine

                collagenase, frozen shoulder, adhesive capsulitis

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