The best available data show that a combination of manual therapy and exercise may not be as effective as glucocorticoid injection in the short-term. It is unclear whether a combination of manual therapy, exercise and electrotherapy is an effective adjunct to glucocorticoid injection or oral NSAID. Following arthrographic joint distension with glucocorticoid and saline, manual therapy and exercise may confer effects similar to those of sham ultrasound in terms of overall pain, function and quality of life, but may provide greater patient-reported treatment success and active range of motion. High-quality RCTs are needed to establish the benefits and harms of manual therapy and exercise interventions that reflect actual practice, compared with placebo, no intervention and active interventions with evidence of benefit (e.g. glucocorticoid injection).
Despite identifying 60 eligible trials, only one trial compared a combination of manual therapy and exercise reflective of common current practice to placebo. We judged it to be of high quality and found no clinically important differences between groups in any outcome. Effects of manual therapy and exercise may be similar to those of glucocorticoid injection and arthroscopic subacromial decompression, but this is based on low quality evidence. Adverse events associated with manual therapy and exercise are relatively more frequent than placebo but mild in nature. Novel combinations of manual therapy and exercise should be compared with a realistic placebo in future trials. Further trials of manual therapy alone or exercise alone for rotator cuff disease should be based upon a strong rationale and consideration of whether or not they would alter the conclusions of this review.
Based upon low quality evidence from one trial, LLLT for six days may be more effective than placebo in terms of global treatment success at six days. Based upon moderate quality evidence from one trial, LLLT plus exercise for eight weeks may be more effective than exercise alone in terms of pain up to four weeks, and function up to four months. It is unclear whether PEMF is more or less effective than placebo, or whether other electrotherapy modalities are an effective adjunct to exercise. Further high quality randomised controlled trials are needed to establish the benefits and harms of physical therapy interventions (that comprise electrotherapy modalities, manual therapy and exercise, and are reflective of clinical practice) compared to interventions with evidence of benefit (for example glucocorticoid injection or arthrographic joint distension).
Based on low quality evidence, therapeutic ultrasound may have short-term benefits over placebo in people with calcific tendinitis, and LLLT may have short-term benefits over placebo in people with rotator cuff disease. Further high quality placebo-controlled trials are needed to confirm these results. In contrast, based on low quality evidence, PEMF may not provide clinically relevant benefits over placebo, and therapeutic ultrasound, LLLT and PEMF may not provide additional benefits when combined with other physical therapy interventions. We are uncertain whether TENS is superior to placebo, and whether any electrotherapy modality provides benefits over other active interventions (e.g. glucocorticoid injection) because of the very low quality of the evidence. Practitioners should communicate the uncertainty of these effects and consider other approaches or combinations of treatment. Further trials of electrotherapy modalities for rotator cuff disease should be based upon a strong rationale and consideration of whether or not they would alter the conclusions of this review.
Background:Outcome measures are an important part of clinical practice to assist with the care of individuals with lower-limb absence (LLA). They aid with the devising and evaluation of rehabilitation plans, and guide decisions regarding the provision and funding of prosthetic services worldwide. To date, no outcome measure has been identified as a gold standard for use in individuals with LLA. Furthermore, the large number of outcome measures available has created uncertainty regarding outcome measures that are most appropriate for individuals with LLA.Objective:To critically appraise the existing literature related to the psychometric properties of outcome measures for use in individuals with LLA and provide evidence as to which outcome measures may be most appropriate for this clinical population.Study design:This is a systematic review protocol.Methods:CINAHL, Embase, MEDLINE (PubMed), and PsycINFO databases will be searched using a combination of Medical Subject Headings terms and keywords. Search terms that define the population (people with LLA or amputation), intervention (outcome measures), and outcome (psychometric properties) will be used to identify studies. The reference lists of included studies will be hand-search to identify other pertinent articles, with a further search conducted through Google Scholar to ensure that all studies not yet indexed through MEDLINE are captured. Full-text peer-reviewed journal studies published in English will be included, with no date limit set. Included studies will be appraised using the 2018 and 2020 COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklists. Data extraction and study appraisal will be completed by two authors, with a third author serving as an adjudicator. Quantitative synthesis will be used to summarize characteristics of the included studies, with kappa statistics used to determine agreement between authors for study inclusion and the application of COSMIN. Qualitative synthesis will be conducted to report on both quality of the included studies and psychometric properties of the included outcome measures.Conclusion:This protocol was designed to identify, appraise, and summarize patient-reported and performance-based outcome measures that have been psychometrically tested in people with LLA. Results from this review will be used to guide a consensus process on outcome measure use for people with LLA.Systematic review registration: PROSPERO registry number: CRD42020217820.
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