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      Corticosteroid Injections Give Small and Transient Pain Relief in Rotator Cuff Tendinosis: A Meta-analysis

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          Abstract

          <div class="section"> <a class="named-anchor" id="d396414e166"> <!-- named anchor --> </a> <h5 class="section-title" id="d396414e167">Background</h5> <p id="Par1">The ability of injection of corticosteroids into the subacromial space to relieve pain ascribed to rotator cuff tendinosis is debated. The number of patients who have an injection before one gets relief beyond what a placebo provides is uncertain. </p> </div><div class="section"> <a class="named-anchor" id="d396414e171"> <!-- named anchor --> </a> <h5 class="section-title" id="d396414e172">Questions/purposes</h5> <p id="Par2">We asked: (1) Do corticosteroid injections reduce pain in patients with rotator cuff tendinosis 3 months after injection, and if so, what is the number needed to treat (NNT)? (2) Are multiple injections better than one single injection with respect to pain reduction at 3 months? </p> </div><div class="section"> <a class="named-anchor" id="d396414e176"> <!-- named anchor --> </a> <h5 class="section-title" id="d396414e177">Methods</h5> <p id="Par3">We systematically searched seven electronic databases for randomized controlled trials of corticosteroid injection for rotator cuff tendinosis compared with a placebo injection. Eligible studies had at least 10 adults and used pain intensity as an outcome measure. The Hedges’s g as adjusted pooled standardized mean difference (SMD) (which expresses the size of the intervention effect in each study relative to the total variability observed among pooled studies) and NNT were calculated at assessment points less than 1 month, 1–2 months, and 2–3 months. The protocol of this study was registered at the international prospective register of systematic reviews. Eleven studies of 726 patients satisfied our criteria for data pooling. Three studies containing 292 patients used repeat injections. A random effects model was used owing to substantial heterogeneity among studies. The funnel plot indicated the possibility of some missing studies, but Orwin’s fail-safe N and Duval and Tweedie’s trim and fill suggested that missing studies would not significantly affect the results. </p> </div><div class="section"> <a class="named-anchor" id="d396414e181"> <!-- named anchor --> </a> <h5 class="section-title" id="d396414e182">Results</h5> <p id="Par4">Corticosteroid injection did not reduce pain intensity in adult patients with rotator cuff tendinosis more than a placebo injection at the 3-month assessment. A small transient pain relief occurred at the assessment between 4 and 8 weeks with a SMD of 0.52 (range, 0.27–0.78) (p &lt; 0.001). At least five patients must be treated for one patient’s pain to be transiently reduced to no more than mild. Multiple injections were not found to be more effective than a single injection at any time. </p> </div><div class="section"> <a class="named-anchor" id="d396414e186"> <!-- named anchor --> </a> <h5 class="section-title" id="d396414e187">Conclusions</h5> <p id="Par5">Corticosteroid injections provide—at best—minimal transient pain relief in a small number of patients with rotator cuff tendinosis and cannot modify the natural course of the disease. Given the discomfort, cost, and potential to accelerate tendon degeneration associated with corticosteroids, they have limited appeal. Their wide use may be attributable to habit, underappreciation of the placebo effect, incentive to satisfy rather than discuss a patient’s drive toward physical intervention, or for remuneration, rather than their utility. </p> </div><div class="section"> <a class="named-anchor" id="d396414e191"> <!-- named anchor --> </a> <h5 class="section-title" id="d396414e192">Level of Evidence</h5> <p id="Par6">Level I, therapeutic study.</p> </div><div class="section"> <a class="named-anchor" id="d396414e196"> <!-- named anchor --> </a> <h5 class="section-title" id="d396414e197">Electronic supplementary material</h5> <p id="d396414e199">The online version of this article (doi:10.1007/s11999-016-5002-1) contains supplementary material, which is available to authorized users. </p> </div>

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          Most cited references38

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          Interpreting the clinical importance of group differences in chronic pain clinical trials: IMMPACT recommendations.

          An essential component of the interpretation of results of randomized clinical trials of treatments for chronic pain involves the determination of their clinical importance or meaningfulness. This involves two distinct processes--interpreting the clinical importance of individual patient improvements and the clinical importance of group differences--which are frequently misunderstood. In this article, we first describe the essential differences between the interpretation of the clinical importance of patient improvements and of group differences. We then discuss the factors to consider when evaluating the clinical importance of group differences, which include the results of responder analyses of the primary outcome measure, the treatment effect size compared to available therapies, analyses of secondary efficacy endpoints, the safety and tolerability of treatment, the rapidity of onset and durability of the treatment benefit, convenience, cost, limitations of existing treatments, and other factors. The clinical importance of individual patient improvements can be determined by assessing what patients themselves consider meaningful improvement using well-described methods. In contrast, the clinical meaningfulness of group differences must be determined by a multi-factorial evaluation of the benefits and risks of the treatment and of other available treatments for the condition in light of the primary goals of therapy. Such determinations must be conducted on a case-by-case basis, and are ideally informed by patients and their significant others, clinicians, researchers, statisticians, and representatives of society at large.
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            Efficacy and safety of corticosteroid injections and other injections for management of tendinopathy: a systematic review of randomised controlled trials.

            Few evidence-based treatment guidelines for tendinopathy exist. We undertook a systematic review of randomised trials to establish clinical efficacy and risk of adverse events for treatment by injection. We searched eight databases without language, publication, or date restrictions. We included randomised trials assessing efficacy of one or more peritendinous injections with placebo or non-surgical interventions for tendinopathy, scoring more than 50% on the modified physiotherapy evidence database scale. We undertook meta-analyses with a random-effects model, and estimated relative risk and standardised mean differences (SMDs). The primary outcome of clinical efficacy was protocol-defined pain score in the short term (4 weeks, range 0-12), intermediate term (26 weeks, 13-26), or long term (52 weeks, ≥52). Adverse events were also reported. 3824 trials were identified and 41 met inclusion criteria, providing data for 2672 participants. We showed consistent findings between many high-quality randomised controlled trials that corticosteroid injections reduced pain in the short term compared with other interventions, but this effect was reversed at intermediate and long terms. For example, in pooled analysis of treatment for lateral epicondylalgia, corticosteroid injection had a large effect (defined as SMD>0·8) on reduction of pain compared with no intervention in the short term (SMD 1·44, 95% CI 1·17-1·71, p<0·0001), but no intervention was favoured at intermediate term (-0·40, -0·67 to -0·14, p<0·003) and long term (-0·31, -0·61 to -0·01, p=0·05). Short-term efficacy of corticosteroid injections for rotator-cuff tendinopathy is not clear. Of 991 participants who received corticosteroid injections in studies that reported adverse events, only one (0·1%) had a serious adverse event (tendon rupture). By comparison with placebo, reductions in pain were reported after injections of sodium hyaluronate (short [3·91, 3·54-4·28, p<0·0001], intermediate [2·89, 2·58-3·20, p<0·0001], and long [3·91, 3·55-4·28, p<0·0001] terms), botulinum toxin (short term [1·23, 0·67-1·78, p<0·0001]), and prolotherapy (intermediate term [2·62, 1·36-3·88, p<0·0001]) for treatment of lateral epicondylalgia. Lauromacrogol (polidocanol), aprotinin, and platelet-rich plasma were not more efficacious than was placebo for Achilles tendinopathy, while prolotherapy was not more effective than was eccentric exercise. Despite the effectiveness of corticosteroid injections in the short term, non-corticosteroid injections might be of benefit for long-term treatment of lateral epicondylalgia. However, response to injection should not be generalised because of variation in effect between sites of tendinopathy. None. Copyright © 2010 Elsevier Ltd. All rights reserved.
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              Meta-analysis and subgroups.

              Subgroup analysis is the process of comparing a treatment effect for two or more variants of an intervention-to ask, for example, if an intervention's impact is affected by the setting (school versus community), by the delivery agent (outside facilitator versus regular classroom teacher), by the quality of delivery, or if the long-term effect differs from the short-term effect. While large-scale studies often employ subgroup analyses, these analyses cannot generally be performed for small-scale studies, since these typically include a homogeneous population and only one variant of the intervention. This limitation can be bypassed by using meta-analysis. Meta-analysis allows the researcher to compare the treatment effect in different subgroups, even if these subgroups appear in separate studies. We discuss several statistical issues related to this procedure, including the selection of a statistical model and statistical power for the comparison. To illustrate these points, we use the example of a meta-analysis of obesity prevention.
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                Author and article information

                Journal
                Clinical Orthopaedics and Related Research®
                Clin Orthop Relat Res
                Springer Nature
                0009-921X
                1528-1132
                January 2017
                July 28 2016
                : 475
                : 1
                : 232-243
                Article
                10.1007/s11999-016-5002-1
                5174041
                27469590
                fcb9cbff-a264-4ccd-8c3c-5b94a3cd9004
                © 2016

                http://www.springer.com/tdm

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