Assessment of description and implementation fidelity of clinical trials involving exercise-based treatment in individuals with rotator cuff tears: a scoping review.

BACKGROUND: For evidence-based practice, clinicians and researchers can rely on well-conducted randomized clinical trials that exhibit good methodological quality, provide adequate intervention descriptions, and implementation fidelity. OBJECTIVE: To assess the description and implementation fidelity of exercise-based interventions in clinical trials for individuals with rotator cuff tears. METHODS: A systematic search was conducted in PubMed, Embase, CINAHL, LILACS, Cochrane Library, Web of Science, SCOPUS and SciELO. Randomized clinical trials that assessed individuals with rotator cuff tears confirmed by imaging exam were included. All individuals must have received an exercise-based treatment. The methodological quality was scored with the Physiotherapy Evidence Database (PEDro) scale. The Template for Intervention Description and Replication (TIDieR) checklist and the National Institutes of Health Behaviour Change Consortium (NIHBCC) were used to assess intervention description and implementation fidelity, respectively. RESULTS: A total of 13 studies were included. Despite their adequate methodological quality, the description of the intervention was poor with TIDieR scores ranging from 6 to 15 out of 24 total points. The TIDieR highest-scoring item was item 1 (brief name) that was reported in all studies. Considering fidelity, only one of the five domains of NIHBCC (i.e., treatment design) reached just over 50%. CONCLUSION: Exercise-based interventions used in studies for individuals with rotator cuff tears are poorly reported. The description and fidelity of the intervention need to be better reported to assist clinical decision-making and support evidence-based practice.

Localized and widespread pressure pain hypersensitivity in patients with episodic or chronic migraine: A systematic review and meta-analysis.

OBJECTIVE: This meta-analysis compared pressure pain sensitivity in trigeminal, cervical spine and remote pain-free areas between migraine patients and headache-free controls considering diagnosis (episodic versus chronic) and sex.Databases and data treatment: Electronic databases were searched for cross-sectional or prospective case-control studies comparing pressure pain thresholds between migraine and headache-free controls. Data were extracted by two reviewers. The risk of bias and methodological quality was assessed by Newcastle-Ottawa Quality Assessment Scale. Meta-analyses of trigeminal, extra-trigeminal (cervical spine) and remote pain-free areas were compared. Frequency of migraine and sex were taken into account. Mean differences (MD) and random effects were calculated. RESULTS: Eighteen studies were included. Patients with migraine showed lower pressure pain thresholds than headache-free controls: trigeminal (MD -71.33 kPa, 95%CI -92.14 to -50.53), cervical spine (MD -68.50 kPa, 95%CI -84.67 to -52.33), and remote pain-free (MD -62.49 kPa, 95%CI -99.52 to -25.45) areas. Differences were consistently significant for episodic migraine in all locations, but only significant in the trigeminal area for chronic migraine (MD -67.36 kOPa, 95%CI -101.31 to -33.42). Overall, women had lower pressure pain thresholds than men. The methodological quality of most studies (66.7%) was good. The results showed a high heterogeneity. CONCLUSION: This meta-analysis found low to high quality evidence showing lower pressure pain thresholds in trigeminal, extra-trigeminal, and remote pain-free areas in migraine sufferers when compared with headache-free controls. Hypersensitivity to pressure pain locally and widespread was consistently observed in episodic migraine, but locally in chronic migraine as compared to headache-free controls. Women with migraine were more sensitive than men.Registration number: https://doi.org/10.17605/OSF.IO/YJTAK.

Has the Phase of the Menstrual Cycle Been Considered in Studies Investigating Pressure Pain Sensitivity in Migraine and Tension-Type Headache: A Scoping Review.

OBJECTIVE: The aim of this scoping review was to identify if the phase of the menstrual cycle was considered in observational studies comparing pressure pain sensitivity between women with migraine or tension-type headache (TTH) and headache-free women. METHODS: A systematic electronic literature search in PubMed, Medline, Web of Science, Scopus, and CINAHL databases was conducted. Observational studies including one or more groups with TTH and/or migraine comparing pressure pain thresholds (PPTs) were included. The methodological quality (risk of bias) was assessed with the Newcastle-Ottawa Scale. Authors, objectives, inclusion/exclusion criteria, size sample, female sample, tool to assess PPTs, mean age, and the use of any medication were extracted and analyzed independently by two authors. RESULTS: From a total of 1404 and 1832 identified articles for TTH and migraine, 30 and 18 studies satisfied the criteria and were included. Nineteen (63.4%) studies assessing TTH patients and eleven (61.1%) assessing migraine patients showed a high risk of bias. The most common flaws were attributed to improper selection of control and control over other additional factors. Based on the systematic review, just one study including TTH and one including migraine patients considered the menstrual cycle. CONCLUSION: The results of this scoping review identified that the phase of the menstrual cycle has been rarely considered in studies investigating sensitivity to pressure pain in primary headaches, such as TTH or migraine, although there is evidence showing the relevance of the phase of the menstrual cycle in pain perception.