Reporting results in manual therapy clinical trials: A need for improvement
Background: The number of randomized clinical trials (RCTs) for manual therapy (MT) has increased exponen- tially in recent years but the quality of reporting is heterogeneous.
Objective: To assess the quality of the reporting of results in RCTs manual therapy, both in the text and in the graphs.Study design: Methodological review.
Methods: We reviewed a random sample of 120 RCTs in MT published between 2000 and 2020 in indexed journals. We identified the primary outcome for each trial, and evaluated the completeness and correctness of reporting of results in the text and in the graphs.
Results: Forty per cent of the RCTs explicitly identified the primary outcome and 47.5% reported a sample size calculation. In 46.7% of the trials, the reporting of between groups comparisons was complete (including effect size and precision). Only 29.2% used the confidence interval as a measure of precision. Fifty-eight per cent of the trials reported significant differences in the results, and 30.8% reported a value of clinical relevance for at least one variable of the study. Forty-seven per cent reported the primary outcome graphically but only 19.6% of the graphs were self explanatory and 66.1% had problems of visual clarity.
Conclusions: Our findings suggest that the reporting of the results in MT trials is generally incomplete and graphics are often poor. These shortcomings could affect the interpretation of the results and their application in clinical practice. Improvements are needed in the reporting of results in order to advance clinical practice and research in manual therapy.
Person-centered versus body-centered approaches in osteopathic care for chronic pain conditions
Ultimately, we would argue that the osteopathic care of individuals with persistent physical symptoms, such as those with FM, should only be considered from a multimodal person-centered perspective. Further, a person-centered and biopsychosocially informed approach to osteopathic care can positively modulate nociplastic changes in central pain pathways and address psychosocial factors typically present in patients with persistent physical symptoms. After repeated calls to move away from biomechanical-postural models of osteopathic care, it is also time for a change in how osteopathic research is designed and conducted to avoid wasting time and resources in the pursuit of predictable results.
Osteopathy: Italian professional profile. A professional commentary by a group of experts of the European community of practice
Osteopathy became recently regulated as a healthcare profession in Italy. The Italian legislation classifies osteopathy as a healthcare profession, which focuses on health prevention and maintenance with a role in rehabilitation and functional psychosocial recovery. The legislative framework also lays down the osteopathic professional profile. Osteopaths are described as healthcare practitioners who deliver osteopathic person- centered care focused on the musculoskeletal system and the concept of somatic dysfunction. Despite these positive developments in the legislation for osteopathy, the Italian law raises critical points regarding the validity of osteopathic care models, namely the concept of somatic dysfunction and the role of osteopaths in health promotion and prevention. The legislative developments currently occurring worldwide must be informed by a critical appraisal of osteopathic conceptual models and grounded on robust research. In the article, a panel of European osteopaths involved in clinical and academic practice, research and regulation, present this profes- sional commentary to facilitate a critical discussion on the role, competencies and scope of practice of osteopaths in the light of the recently published Italian osteopathic professional profile.
Opposing vaccine hesitancy during the COVID-19 pandemic – A critical commentary and united statement of an international osteopathic research community
The trusted role and professional standing that osteopaths have with their patients and within their wider communities requires that the information and messages they communicate are informed by and congruent with current evidence, public health guidance and scientific consensus. This expectation is even more critical during the COVID-19 pandemic, particularly in relation to sharing information and decisions with patients regarding vaccination. All osteopaths have a social, moral and professional duty to contribute to the prevention of the transmission of infectious diseases. Practitioners must be critically aware when traditional osteopathic theories, principles and ideology may appear to contradict public health advice. Osteopaths should correct erroneous reasoning, false claims or misleading messaging to ensure that their professional practice and advice follow the most robust and recent evidence, public health advice and regulatory requirements.
A national cross-sectional survey of the attitudes, skills and use of evidence-based practice amongst Spanish osteopaths
Background: Although evidence-based practice (EBP) is largely supported across healthcare professions, its implementation in manual therapy professions such as osteopathy remains limited and debated. There is currently little knowledge of how Spanish osteopaths relate to EBP.
Objectives: The main aim of this study was to investigate the attitudes, skills and use of EBP among Spanish osteopaths. A secondary aim was to identify barriers and facilitators for the adoption of EBP in the Spanish osteopathic context.
Methods: National cross-sectional survey of Spanish osteopaths registered and non-registered to an osteopathic association in Spain. Eligible participants were invited by a range of recruitment strategies including email and social media campaigns to complete the Spanish-translated Evidence-Based practice Attitude and utilization Survey (EBASE) anonymously online.
Results: A total of 567 osteopaths completed the survey which represents an approximate response rate of 9%. Participant’s attitudes toward EBP were largely positive. Most respondents agreed or strongly agreed that EBP was necessary in the practice of osteopathy (89.6%) and that professional literature and research findings were useful to their day-to-day practice (88.9%). Levels of perceived skill in EBP were reported as low to moderate with lowest levels for items related to ‘research conduct’. Except reading/reviewing professional literature and using online search engines to find practice-related literature, participant engagement in all other EBP-related activities was generally infrequent. The perceived proportion of clinical practice that was based on clinical research evidence was reported to be very small. Main barriers to EBP uptake included a lack of clinical evidence in osteopathy and insufficient skills for applying research findings. Main facilitators of EBP uptake included access to full-text articles, internet at the workplace and online databases.
Conclusions: Spanish osteopaths were largely supportive of evidence-based practice, had low to moderate skills in EBP and engaged in EBP activities infrequently. Formal regulation of the profession in Spain and the inclusion of osteopathic programs into the university sector would potentially improve EBP skills and use.
Sample size, study length, and inadequate controls were the most common self-acknowledged limitations in manual therapy trials: A methodological review
The aim of this study was to quantify and analyze the presence and type of self-acknowledged limitations (SALs) in a sample of manual therapy (MT) randomized controlled trials.
Study Design and Setting
We randomly selected 120 MT trials. We extracted data related to SALs from the original reports and classified them into 12 categories. After data extraction, specific limitations within each category were identified. A descriptive analysis was performed using frequencies and percentages for qualitative variables.
The number of SALs per trial article ranged from 0 to 8, and more than two-thirds of trials acknowledged at least two different limitations. Despite its small proportion, 9% of trials did not report SALs. The most common limitation declared, in almost half of our sample, related to sample size (47.5%) followed by limitations related to study length and follow-up (33.3%) and inadequate controls (32.5%).
Our results indicate that at least two different limitations are consistently acknowledged in MT trial reports, the most common being those related to sample size, study length, follow-up, and inadequate controls. Analysis of the reasons behind the SALs gives some insights about the main difficulties in conducting research in this field and may help develop strategies to improve future research.
Covid-19: Guía para la adaptación higiénico – sanitaria de los consultorios profesionales osteopáticos
El propósito de este documento es difundir a los osteópatas la información para la introducción de las normas higiénico-sanitarias para la prevención de la propagación de Covid-19 dentro de los consultorios profesionales, proporcionando indicaciones y listas de verificación para facilitar la adopción de las recomendaciones de prevención y control de las infecciones. Este documento puede ser un complemento adicional a las pautas actuales a nivel nacional y regional y en ningún caso puede prevalecer sobre tales indicaciones.
The Spanish Osteopathic Practitioners Estimates and RAtes (OPERA) study: A cross-sectional survey
Background: Despite the growth of the osteopathic profession in Spain in the last few years, reliable information regarding professional profile and prevalence is still lacking. The Osteopathic Practitioners Estimates and RAtes (OPERA) project was developed as a European-based survey dedicated to profiling the osteopathic profession across Europe. The present study aims to describe the characteristics of osteopathic practitioners, their professional profile and the features of their clinical practice.
Methods: A voluntary, validated online-based survey was distributed across Spain between January and May 2018. The survey, composed of 54 questions and 5 sections, was formally translated from English to Spanish and adapted from the original version. Because there is not a unique representative osteopathic professional body in Spain, a dedicated website was created for this study, and participation was encouraged through both specific agreements with national registers/associations and an e-based campaign.
Results: A total of 517 osteopaths participated in the study, of which 310 were male (60%). The majority of respondents were aged between 30–39 years (53%) and 98% had an academic degree, mainly in physiotherapy. Eighty-five per cent of the respondents completed a minimum of four-year part-time course in osteopathy. Eighty-nine per cent of the participants were self-employed. Fifty-eight per cent of them own their clinic, and 40% declared to work as a sole practitioner. Thirty-one per cent see an average of 21 to 30 patients per week for 46–60 minutes each. The most commonly used diagnostic techniques are movement assessment, palpation of structures/position and assessment of tenderness and trigger points. Regarding treatment modalities, articulatory/mobilisation techniques followed by visceral techniques and progressive inhibition of neuromuscular structures is often to always used. The majority of patients estimated by the respondents sought osteopathic treatment for musculoskeletal problems mainly localised on the lumbar and cervical region. The majority of respondents manifest a robust professional identity and a collective desire to be regulated as a healthcare profession.
Conclusions: This study represents the first published document to determine the characteristics of the osteopathic practitioners in Spain using large, national data. To date, it represents the most informative document related to the osteopathic community in Spain. It brings new information on where, how, and by whom osteopathy is practised in the country. The information provided could potentially influence the development of the profession in Spain.
Professional identity in the evolution of osteopathic models: Response to Esteves et al.
After several publications calling for changes within our profession, the recent editorial published by Esteves et al. “Models and theoretical frameworks for osteopathic care – A critical view and call for updates and research” represents a reflection worth considering for the entire osteopathic community. Osteopathy only can progress through a self-reflecting process that generates an honest debate on the strengths and shortcomings of the profession. While we support the proposal made by the authors related to the generation of new frameworks and models, in the present response we focus on some aspects that could explain why many osteopaths remain stuck in outdated models, theories and practices. We argue that these aspects constitute a barrier to close the gap between scientists, clinicians and educators and prevent the evolution towards new working models. In the core of our argument, there is the concept of “professional identity” as one of the most determining factors to explain the “osteopathic reluctance” to overcome or evolve away from old beliefs, models and traditions. In fact, the relationship between osteopathic models and professional identity is already mentioned in the first and last sentence of Esteves et al. paper.
Beliefs about chronic low back pain amongst osteopaths registered in Spain: A cross-sectional survey
Background: Healthcare providers’ (HCPs) attitudes and beliefs might influence patients’ attitudes and beliefs as well as their management approach. It was hypothesised that osteopaths have a more biopsychosocial mindset towards chronic low back pain (CLBP) because of their holistic reasoning.
Objective: The primary aim of the study was to assess the beliefs of osteopaths registered in Spain about CLBP and the presence of kinesiophobic and fear-avoidance beliefs. The secondary aim was to compare these results with previous research and cut-off values.
Method: Members of the Spanish Federation of Osteopaths (FOE) were invited to participate in an online cross-sectional survey based on three questionnaires: the Health Care providers Pain and Impairment Relationship Scale (HC-PAIRS), the Tampa Scale of Kinesiophobia 11-item version for healthcare providers (TSK(11)-HC) and the Fear Avoidance Beliefs Questionnaire for healthcare providers (FABQ-HC). The mean scores were calculated for each questionnaire and correlations were established to assess the strength of the associations between the different instruments. The results were compared to previous research with other HCPs and to cut-off scores where available.
Results: The response rate was 14.58% (n = 70). The mean score on the HC-PAIRS was 59.44 ± 12.19 [CI 95% 56.54–62.35] and there was a large variation in scores. On the TSK(11)-HC and FABQ-HC 28.6% and 25.7% of the sample respectively reached the cut-off scores.
Conclusion: The study suggests that the Spanish osteopaths do not have a more biopsychosocial orientation towards the management of CLBP than other HCPs. Approximately a quarter of them hold kinesiophobic and fear-avoidance beliefs that might negatively influence their treatment approach.
A methodological review revealed that reporting of trials in manual therapy has not improved over time
Objective: The aim of this review was to evaluate a selection of major reporting aspects in manual therapy (MT) trials, before and after the publication of the CONSORT extension for nonpharmacological trials (CONSORTnpt)
Study Design and Setting: We randomly selected 100 MT trials published between 2000 and 2015 and divided them into a pre- CONSORTnpt (n=50) and a post-CONSORTnpt (n=50) group. We extracted data on relevant issues of internal validity, reliability, and description of interventions. Two authors extracted data independently. Percentages were used for descriptive analyses, and Fisher’s exact test and the chi-square test were used for group comparisons.
Results: Six different types of MT interventions with up to 20 controls were analyzed. The most common populations/conditions studied were healthy subjects and subjects with lower back or neck pain. Over 70% of studies included multi-session interventions, and 42% of studies reported long-term followup. The only significant differences between groups were the inclusion of a flowchart diagram, the estimated effect size, precision descriptions, and the description of intervention procedures.
Conclusion: Our findings suggest that trials in MT show poor reporting even after the availability of standardized guidelines. ! 2020 Elsevier Inc. All rights reserved.
Profile of osteopathic practice in Spain: results from a standardized data collection study
There is limited research regarding patients’ profiles and consumer attitudes and habits of osteopathy in Spain. The purpose of this study was to profile patients who regularly receive osteopathic care in Spain using an internationally developed standardized data collection tool. Method: During the period between April 2014 and December 2015, a UK-developed standardized data collection tool was distributed to Spanish osteopaths who voluntarily agreed to participate in this cross-sectional study. Result: Thirty-six osteopaths participated in this study and returned a total of 314 completed datasets. Of 314 patients, 61% were women and 39% were men, with a mean age of 40 years (SD 17.02 years, range 0 to 83 years). Forty-four percent were full-time salaried workers, and in 78% of cases, receiving osteopathic treatment was the patient’s own choice. Chronic spinal pain presentations were the most frequent reasons for consultation. Seventy-five percent of patients presented with a coexisting condition, mainly gastrointestinal disorders and headaches. The main treatment approach consisted of mobilization techniques, followed by soft tissue, cranial and high velocity thrust techniques. Improvement or resolution of the complaint was experienced by 93% of patients after a small number of sessions. Adverse events were minor and occurred in 7% of all cases. Conclusion: This is the first study carried out in Spain analyzing the profile of patients who receive osteopathic care. The typical patient who receives osteopathic care in Spain is middle-aged, presents mainly with chronic spinal pain, and voluntarily seeks osteopathic treatment. Osteopathic treatment produces a significant improvement in the majority of cases with a low rate of minor adverse events reported.
Using the template for intervention description and replication (TIDieR) as a tool for improving the design and reporting of manual therapy interventions.
The detailed reporting of any research intervention is crucial to evaluate its applicability into a routinely practice-based context. However, it has been estimated that, especially in non-pharmacological interventions, the published literature typically includes incomplete intervention details. In the field of manual medicine, where interventions are delivered with a high degree of individualization and variability, poorly reported studies could compromise internal and external validity of the results. Among the various initiatives that have been undertaken to improve the intervention description, the Template for Intervention Description and Replication (TIDieR) has to be highlighted as the most promising. TID ie R offers both to researchers and clinicians helpful and comprehensive guidance on how manual therapy interventions have to be designed and reported, taking into account the clinical complexity of manual therapy and the need to satisfy research gold standards.
Comentarios a raíz del vídeo “La Osteopatía a juicio”
Gerard Alvarez MSc DO, Sonia Roura MSc DO, Daniel Ruiz MSc CO, Mayte Serrat MSc DO
YouFisio es un reciente canal de YouTube cuya finalidad es la divulgación científica en el entorno de la Fisioterapia. La acogida de este canal ha sido relevante en España acumulando actualmente más de 1000 seguidores y un fuerte impacto mediático en el colectivo. El pasado 5 de Noviembre del 2017 se publicó en dicho canal el vídeo “La Osteopatía a juicio”. Visualizado el documento, varios miembros de COME Spain, hemos sentido la necesidad de complementar y matizar algunos de los aspectos que se mencionan en el vídeo con el fin de ampliar la visión que se ofrece de las bases científicas de la Osteopatía. Manifestamos la presencia de un sesgo de publicación y la omisión de datos relevantes para poder juzgar adecuadamente las fortalezas y debilidades de la base científica de la Osteopatía. Esta no es una réplica al contenido del vídeo el cual compartimos en buena medida. Nuestra intención no es otra que la de mostrar la Osteopatía que no ha sido reflejada en el vídeo, una Osteopatía contemporánea que acepta el método científico como herramienta de progreso y evolución y que lo utiliza como elemento crítico para mejorar su aplicación.