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      Effects of 12 Weeks of Progressive Early Active Exercise Therapy After Surgical Rotator Cuff Repair: 12 Weeks and 1-Year Results From the CUT-N-MOVE Randomized Controlled Trial

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          Abstract

          Background:

          Traumatic full-thickness rotator cuff tears are typically managed surgically, followed by rehabilitation, but the load progression to reach an optimal clinical outcome during postoperative rehabilitation is unknown.

          Purpose:

          To evaluate whether there was a superior effect of 12 weeks of progressive active exercise therapy on shoulder function, pain, and quality of life compared with usual care.

          Study Design:

          Randomized controlled trial; Level of evidence, 1.

          Methods:

          Patients with surgically repaired traumatic full-thickness rotator cuff tears were recruited from 2 orthopaedic departments and randomized to progressive active exercise therapy (PR) or limited passive exercise therapy (UC [usual care]). The primary outcome was the change in the Western Ontario Rotator Cuff Index (WORC) score between groups from before surgery to 12 weeks after surgery. Secondary outcomes included changes in the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire score, pain, range of motion, and strength. Adverse events were registered during the intervention period.

          Results:

          A total of 82 patients were randomized to the PR (n = 41) or UC (n = 41) group. All 82 patients (100%) participated in the 12-week assessment and 79 in the 1-year follow-up. At 12 weeks, there was no significant difference between the groups in the change in the WORC score from baseline adjusted for age, sex, and center (physical symptoms: P = .834; sports and recreation: P = .723; work: P = .541; lifestyle: P = .508; emotions: P = .568). Additionally, there was no between-group difference for the secondary outcomes including the WORC score at 1 year and the DASH score, pain, range of motion, and strength at 12 weeks and 1 year. Both groups showed significant improvements over time in all outcomes. In total, there were 13 retears (16%) at 1-year follow-up: 6 in the PR group and 7 in the UC group.

          Conclusion:

          PR did not result in superior patient-reported and objective outcomes compared with UC at either short- or long-term follow-up (12 weeks and 1 year).

          Registration:

          NCT02969135 ( ClinicalTrials.gov identifier)

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          Most cited references48

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          Development of an upper extremity outcome measure: the DASH (disabilities of the arm, shoulder and hand) [corrected]. The Upper Extremity Collaborative Group (UECG)

          This paper describes the development of an evaluative outcome measure for patients with upper extremity musculoskeletal conditions. The goal is to produce a brief, self-administered measure of symptoms and functional status, with a focus on physical function, to be used by clinicians in daily practice and as a research tool. This is a joint initiative of the American Academy of Orthopedic Surgeons (AAOS), the Council of Musculoskeletal Specialty Societies (COMSS), and the Institute for Work and Health (Toronto, Ontario). Our approach is consistent with previously described strategies for scale development. In Stage 1, Item Generation, a group of methodologists and clinical experts reviewed 13 outcome measurement scales currently in use and generated a list of 821 items. In Stage 2a, Initial Item Reduction, these 821 items were reduced to 78 items using various strategies including removal of items which were generic, repetitive, not reflective of disability, or not relevant to the upper extremity or to one of the targeted concepts of symptoms and functional status. Items not highly endorsed in a survey of content experts were also eliminated. Stage 2b, Further Item Reduction, will be based on results of field testing in which patients complete the 78-item questionnaire. This field testing, which is currently underway in 20 centers in the United States, Canada, and Australia, will generate the final format and content of the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire. Future work includes plans for validity and reliability testing.
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            Recommended methods for determining responsiveness and minimally important differences for patient-reported outcomes.

            The objective of this review is to summarize recommendations on methods for evaluating responsiveness and minimal important difference (MID) for patient-reported outcome (PRO) measures. We review, summarize, and integrate information on issues and methods for evaluating responsiveness and determining MID estimates for PRO measures. Recommendations are made on best-practice methods for evaluating responsiveness and MID. The MID for a PRO instrument is not an immutable characteristic, but may vary by population and context, and no one MID may be valid for all study applications. MID estimates should be based on multiple approaches and triangulation of methods. Anchor-based methods applying various relevant patient-rated, clinician-rated, and disease-specific variables provide primary and meaningful estimates of an instrument's MID. Results for the PRO measures from clinical trials can also provide insight into observed effects based on treatment comparisons and should be used to help determine MID. Distribution-based methods can support estimates from anchor-based approaches and can be used in situations where anchor-based estimates are unavailable. We recommend that the MID is based primarily on relevant patient-based and clinical anchors, with clinical trial experience used to further inform understanding of MID.
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              Prevalence and risk factors of a rotator cuff tear in the general population.

              Little information is available about the epidemiology of rotator cuff tears in a population-based study. The purpose of this study was to elucidate the true prevalence of rotator cuff tears regardless of the presence or absence of symptoms in the general population and to assess the relationship between tears and their backgrounds. A medical check-up was conducted for residents of a mountain village in Japan. The subjects consisted of 683 people (total of 1,366 shoulders), including 229 males and 454 females with a mean age of 57.9 years (range, 22-87). We examined their background factors, physical examinations and ultrasonographic examinations on both shoulders. Rotator cuff tears were present in 20.7% and the prevalence increased with age. Thirty-six percent of the subjects with current symptoms had rotator cuff tears, while 16.9% of the subjects without symptoms also had rotator cuff tears. Rotator cuff tears in the general population were most commonly associated with elderly patients, males, affected the dominant arm, engaged in heavy labor, having a history of trauma, positive for impingement sign, showed lesser active forward elevation and weaker muscle strength in abduction and external rotation. A logistic regression analysis revealed the risk factors for a rotator cuff tear to be a history of trauma, dominant arm and age. 20.7% of 1,366 shoulders had full-thickness rotator cuff tears in the general population. The risk factors for rotator cuff tear included a history of trauma, dominant arm and age. Level 3.
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                Author and article information

                Journal
                The American Journal of Sports Medicine
                Am J Sports Med
                SAGE Publications
                0363-5465
                1552-3365
                February 2021
                January 20 2021
                February 2021
                : 49
                : 2
                : 321-331
                Affiliations
                [1 ]Department of Physical and Occupational Therapy, Copenhagen University Hospital Bispebjerg Frederiksberg, Copenhagen, Denmark
                [2 ]Department of Sports Science and Clinical Biomechanics, Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark
                [3 ]Institute of Sports Medicine, Department of Orthopaedic Surgery M, Copenhagen University Hospital Bispebjerg Frederiksberg, Copenhagen, Denmark
                [4 ]Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark
                [5 ]The Parker Institute, Copenhagen University Hospital Bispebjerg Frederiksberg, Copenhagen, Denmark
                [6 ]Section for Sports Traumatology, Department of Orthopaedic Surgery, Copenhagen University Hospital Bispebjerg Frederiksberg, Copenhagen, Denmark
                [7 ]Shoulder-Elbow Unit, Department of Orthopaedic Surgery, Copenhagen University Hospital Herlev Gentofte, Copenhagen, Denmark
                Article
                10.1177/0363546520983823
                33471547
                d4e101df-7775-4342-8a27-2cbf2174d973
                © 2021

                http://journals.sagepub.com/page/policies/text-and-data-mining-license

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