At a 10-Year Follow-up, Tendon Repair Is Superior to Physiotherapy in the Treatment of Small and Medium-Sized Rotator Cuff Tears

At a 10-Year Follow-up, Tendon Repair Is Superior to Physiotherapy in the Treatment of Small and Medium-Sized Rotator Cuff Tears

To repair or not to repair, that is the question. This recent paper by Moosmayer et al (2019) appears to provide some much-needed evidence in relation to this question. The authors of this randomised controlled trial conclude: ‘At 10 years, the differences in outcome between primary tendon repair and physiotherapy for small and medium-sized rotator cuff tears had increased, with better results for primary tendon repair.’

When considering whether to go ahead with a surgical repair of the torn rotator cuff, both clinicians and patients are rightfully mindful of the long-term implications of such a decision. Therefore, this 10-year follow-up study is an important contribution to the evidence base.

However, it can be seductive to think that this study supports the need for rotator cuff repair surgery in people with small to medium-sized rotator cuff tears. As always, the devil is in the detail and it is important to read beyond the headline conclusion reported in the abstract.

There are many points of discussion that this paper raises. But, in this short blog, I will focus on statistical significance versus clinical importance and the confidence interval.

The headline figure from Moosmayer et al (2019) is that there is a statistically significant difference between the two treatment groups (surgery versus physiotherapy) in favour of the surgical group with reference to the primary outcome measure, the Constant score. However, statistical significance tells you nothing about clinical importance. For example, you might have a statistically significant difference of 0.4 points on a visual analogue scale but that difference is not recognizable or meaningful to clinicians or patients. However, with regards to this study, the difference between groups is reported as 9.6 points on the Constant Score and a clinically important difference is 10 points. So, this is close and any critique suggesting this is not relevant based on lacking 0.4 points is open to challenge given the uncertainty around determining clinically important differences.

But, and there is a big but here, the point estimate, i.e. 9.6 points on the Constant Score, does not tell the whole story. When we do research, we recruit a sample of patients rather than the whole population and then we attempt to infer the results from this sample to the wider population. Given that the smaller sample cannot be fully representative of the whole population, e.g. everyone with rotator cuff tears, there is always some uncertainty around the treatment effects observed in the sample. Often we express this uncertainty in terms of confidence intervals, i.e. the range of values In which the true population value lies. So, although the estimate of 9.6 points difference on the Constant Score might represent the sample, it doesn’t necessarily reflect the difference in the population and so we need to express a degree of uncertainty.

Despite current convention, it is interesting to note that Moosmayer et al (2019) do not report such confidence intervals in the abstract. But, when reading the full paper, they are easily accessible in Table IV where the confidence interval is reported as 3.6 to 15.7. This means that in the population of patients with rotator cuff tear, surgical repair is superior to physiotherapy and the difference in clinical outcomes, measured on the Constant Score, might range from 3.6 points (clinically meaningless) to 15.7 points (clinically meaningful).

Where from here? Well, there is still a degree of uncertainty. All thing being equal (and that is open to question), surgery offers superior clinical outcomes to physiotherapy at 10-years as measured by the Constant Score. But, that superiority might not be clinically recognisable to the patient and clinician and any decision to undergo surgery needs to consider the risk, burden, e.g. time off work, and patient preference. So, the clinical discussion might be along the following lines; ‘you have a rotator cuff tear, we have different treatment options including surgical repair, physiotherapy, or we could wait and see. Surgical repair seems to offer better clinical outcomes 10 years after surgery, not so after 1, 2 or 5 years, but the extent of this benefit is unclear. If you do opt for surgery then you need to think about the risk and burden of surgery and whether that is acceptable to you given that the clinical importance of long-term benefits are unclear.

Management of rotator cuff tears remains challenging with much uncertainty. My own view is that we need to be more balanced in reporting such research and remain open to the current uncertainty.

Thanks for making it this far – comments welcome and appreciated.

Chris

My name is Gareth, and despite conventional wisdom, I'm a man trying to do two things at once.

Understanding how to become a clinical academic is not as straight forwards as it should be, unless you know one. I hope this blog can help. My name is Gareth, I’m an MSK physio, and I’m trying to become a clinical academic, and this is how I got ‘here’. Clinically, ‘here’ for me is being 39 years old and one of a dying breed of NHS physio’s. I’m a physio without an acronym. I’m neither an ESP, or an ACP, or an FCP, because ultimately, I want to be a physio. But I want to be a physio with the ability to challenge practice and try to answer some of the many questions I have, and luckily, I’ve stumbled across a way in which I hope I can do that……one day.

I’ve been through the standard clinical journey.

Phase 1 - Knowing nothing

Phase 2 - Immersion in as many paradigms for assessment and treatment as possible.

Phase 3 - Disillusionment with the lack of consistent outcomes and now thankfully,

Phase 4 – some peace with the uncertainty of clinical practice and often equipoise.

This long, expensive journey included numerous courses, lost weekends, a masters, quite a lot of reading; and you know what? It’s been great and I love being a physio despite the uncertainties. I remain jealous of those who have strong opinions, despite the uncertainty surrounding musculoskeletal diagnosis, mechanisms of treatment effects and how to measure them. I know I’d be a rubbish NHS manager and I’ve never wanted to be an ESP (as utilising more invasive treatments in this world of uncertainty doesn’t suit me). What I want to do, is see if I can answer just some of the questions, I have from clinical practice to improve outcomes for patients. It is this desire that has brought me ‘here’, on a pathway to hopefully achieving an NIHR fellowship. The journey so far has been a world of exciting opportunities and challenges that have given me the best years of my 18-year career. If you choose to read on, then do so knowing that this is not a ‘look what I’ve achieved’ kind of blog; and is far more of a ‘I really would like to raise awareness that these amazing opportunities exist for physios like me and Chris Littlewood twisted my arm a little bit’ kind of blog.

In 2014, having been a Band 7 physio for 10 years, I achieved a split clinical / research role which allowed me two days a week, working in the Research and Development team at my NHS Trust. Here I acted as site lead for physio-lead orthopaedic studies (principal investigator) and was provided with training on the practicalities of setting up and running a research trial. This mix of training and on-the-job experience whetted my appetite to start to do my own research. However, finding a vehicle for this ambition is not easy. In 2017, however, I discovered the Health Education England (HEE) funded Masters to Doctorate Bridging Programme (MDBP).

https://www.birminghamhealthpartners.co.uk/education/clinical-academic-careers-programmes/pre-doctoral-bridging-programme/

This competitive internship supports clinicians who wish to become clinical academics via the HEE-NIHR funded Integrated Clinical Academic fellowships (link below).  This internship provided me with 15 hours of taught lectures on a variety of research topics, gave me access to the University library, provided with a network of supportive people with the same ambition as me and most importantly, provided me with the essential academic support I needed in the shape of Dr Chris Littlewood and Dr Seth O’Neill. From this point onwards, despite numerous challenges, I haven’t looked back and I will now be applying for the Clinical Doctoral Research Fellowship in April 2020. A fully salaried 3-year training fellowship which will allow me to develop the skills necessary to become a researcher in my own rite, whilst developing as a clinician and ensuring that my role can be integrated into my department on completion.

https://www.nihr.ac.uk/explore-nihr/academy-programmes/hee-nihr-integrated-clinical-academic-programme.htm

Working with Chris and Seth over the last 18-months has been challenging and rewarding in equal measure. We first constructed a plan back in November 2017. A publication plan to answer questions that will inform a trial that will be part of my fellowship (should I be successful). So far, I’ve published 2 papers as lead author, presented posters at national and international conferences and completed my first platform presentation this year. I’ve got one or two papers in the pipeline and more presentations later this year. I’ve obtained smaller HEE grants which have funded travel, accommodation and training opportunities which have enabled me to collaborate with international experts in my field of interest (Greater Trochanteric Pain Syndrome, if you’re interested..).

The working relationship with my academic supervisors has gone well and has opened more doors for me. It has also enabled me to obtain a 10-month secondment at Keele University to lead on a qualitative research study which is embedded within a pilot RCT.

https://www.keele.ac.uk/racer/

This experience of working in a Clinical Trials Unit, has also been invaluable. The chance to discuss and develop ideas with people from such a range of backgrounds is such a privilege and makes my clinical work even more rewarding. Even better still, I’ve met some great people and enjoyed a beer or two along the way. Its not been without its challenges. There are plenty of hurdles to overcome and juggling of priorities to manage. It’s also hard work; I feel like I’m almost doing a PhD, just to get on another one at times! But it has been really, really rewarding.

If you have got this far then part of you must want to pursue a career as a clinical academic. As you can see, my path has not been conventional. I took a split physio / research role almost 5-years ago now and only now really feel like I have some momentum. It can be challenging and frustrating and you HAVE to grow a thick skin pretty quickly! But there are opportunities out there that will help buy you time and most importantly, help you develop a team (YOUR TEAM IS EVERYTHING!). Once you’ve got those things then doors open and with a fair amount of hard work, you too could be ‘here’ or wherever it is on the clinical-academic pathway you wish to be.

If you’d like to get in touch about any of the above, please feel free. I’m happy to share my experiences; warts ‘n’ all.

My name’s Chris, and I’m an acdemic…

I qualified as a physiotherapist in 1998 and worked for 10 years as a clinician (UK NHS and private sector) before moving in to academia. My interest in research began very early in my training and while working full-time as a clinician I undertook an MSc in Health Services Research between 2003 and 2005. During this period I reached out to other active researchers asking if I could join them and also began writing for publication. This eventually led to a full-time position at a University and a PhD.

But, as I write this blog I have been away from clinical practice for over 10 years. My wife has been saying for a long time, ‘you can’t call yourself a physiotherapist because you don’t treat patients!’ I used to defend that point, but now I am happy to concede that she is right. I am an academic…

Let me explain my transition, my crisis of confidence and now my acceptance. As an academic, my day-to-day job includes identifying useful research questions, collaborating with patients, clinicians, and other academics for this purpose, writing grant applications, securing ethical approval, setting up and monitoring large-scale research studies, preparing reports and publications, presenting at conferences, managing a diverse group of people, and herding cats. There’s a lot more that my day-to-day job involves, including supervising, mentoring, reviewing, assessing, teaching but the reason for me stating these things is to highlight how different my role is now to that of a senior physiotherapist 10 years ago.

I often hear criticism of academics for not understanding the ‘real’ clinical world. I understand the basis for this criticism, but I think one problem is that some of this criticism is based on a lack of understanding of the academic role (yes, yes, I recognise it’s far more complicated than that but this is a blog trying to deal with one aspect of a complex issue).

Let me give you an example. The SPeEDy study (surgery versus physiotherapist-led exercise for traumatic tears of the rotator cuff) was an idea conceived over two years ago. Many clinical physiotherapists would ask me; ‘what about traumatic rotator cuff tears, what should we do with them?’ Then, a patient approached me; ‘I’ve got this problem, here’s my history; what should I do?’ So, as an academic, I looked in to the research literature. I could see that clinical views were strong but there was a real case for uncertainty and a case for further research. I reached out to clinicians (surgeons and physiotherapist), patients, and other academics to develop an application for research funding. Last year this application was funded. We will work with expert clinicians (surgeons and physiotherapists) across eight hospitals in the UK. They will be integral to the development of this study. I also reached out to physiotherapists, asking them for their input on the physiotherapist-led exercise intervention, rather than relying on my individual views. We are now in the process of setting this study up, developing study processes, seeking ethical approval etc etc. This is now my day-to-day role.

So, what is my intention for writing this blog? Principally to highlight the different skill sets; it’s not an ‘us’ versus ‘them’ type scenario, but rather a recognition of different skill sets. I recently stopped delivering my ‘rotator-cuff’ courses for a number of reasons, but a part of this was me recognising my role as an academic and naturally my case for uncertainty, which is not always a good outcome from a clinical course. I am far more comfortable now with uncertainty, not knowing, but wanting to find out the ‘right’ answer. As a young clinician I valued my training in McKenzie’s method of Mechanical Diagnosis & Therapy (MDT) tremendously. I spent a lot of time and money on this training and it helped my confidence so much. But then I began the diploma in MDT and realised that many of the claims were not substantiated. Overnight I went from a confident clinician to a blubbering idiot! This was difficult because much of my clinical efficiency and reputation had developed in relation to this approach. Essentially. I had become conflicted without knowing.

Of course, I still have conflicts, often unconscious. But I have the luxury of not having that clinical pressure when designing and delivering research. This links to the concept of equipoise which is an important concept underpinning research. Essentially if you’re an advocate of an approach then legitimately the clinical and research communities can ask whether you are the best person to be leading that research.

Working together is the answer, recognising the different skill sets.

Thanks for making it this far.

Chris

Reflections on my application for an NIHR fellowship

Each year the National Institute for Health Research (NIHR) in the UK award a range of fellowships to support individuals (clinicians, academics etc from a range of backgrounds) on a trajectory to becoming future leaders in NIHR research. What the fellowship offers is dependent on the person applying and the stage of their career, among other things. Full details of the NIHR fellowship programmes are available here .

In August of 2018 I was awarded an NIHR post-doctoral fellowship which, for me, means that my salary is covered for the next four years to undertake a bespoke training programme while undertaking further research and engaging with leading clinical and academic mentors to facilitate my development as a future leader in NIHR research. So, you can see already that an award of an NIHR fellowship provides major opportunities.

I often get requests for advice from people thinking about embarking on this journey so in this blog I want to reflect on my application process, hoping it will be useful for others. But, to add a caveat; this blog is my reflection on my experience and is not official advice from the NIHR. For those wanting official advice then the NIHR academy are easy to contact via their website and are always happy to advise. Also, I have now applied for three fellowships;

·       - The first one was successful but I thought my application could have been better and was disappointed with my performance at the interview.

·       - The second one was unsuccessful but I was really pleased with both my application and my interview!

·       - The third one was successful; I was really pleased with my application but genuinely gutted after the interview, I thought I could have done so much better, so much so that I was already making alternative plans before hearing that the fellowship had been awarded.

This tells me that I am no expert in the decision making process that leads to the award of a NIHR fellowship and I do not have any magic solutions to offer. Please bear this in mind if you choose to read on…

The process starts with the application form

In short, no it does not! Fellowships are personal awards to support the development of individuals capable of making an impact through NIHR research. The fellowship application is judged in relation to the person, the place(s) where the fellowship would be hosted as well as the supervisors or mentors, the training programme and the research project. Recognising all these components, if your thought process begins at the time the application is live then I suspect you might submit an application that you will later reflect could have been better, or might never actually get to the point of submitting.

Planning to submit an application begins months in advance. I first approached my manager at Keele, Professor Nadine Foster, in May 2017 prior to a December 2017 submission date. We both recognised that the six months window was tight but worth a go. I had the advantage of my previous NIHR fellowship which had given me a significant boost and also I had recently received funding from the NIHR for another study so my CV was ready in terms of publications, invited presentations, awards and research grant capture etc (all important academic metrics). These factors all contribute to the assessment of the person in this context. Most often, at the outset of this fellowship pathway, these aspects of the CV need to be developed and it is important to recognise this right from the start so that you are ready to submit the best application you can. This might mean that planning begins two to three years before your fellowship application is submitted. Thankfully now the NIHR, for example, offer pre-doctoral fellowships to support in this way (more details on the NIHR website here ).

The person

Unlike research project grants where funds are awarded to a project team, these fellowships are awarded to individuals, as described. So, success can be very sweet for that individual but the opposite is also true. When my first application for a post-doctoral fellowship was not supported in 2015 it really knocked me back and made me question my future steps. Not long after this rejection, Nadine Foster reached out to me from Keele to ask whether I would like to spend some time with her and her team to contribute to their research but also develop my own research ideas. Despite the resulting five hour commute from my home in Yorkshire to Keele in Staffordshire, I did not hesitate to accept the offer. Looking back, I’m not sure where I would have been now without Nadine’s offer of support; I guess that is one of those pivotal moments that happens to many of us in our lives. Why am I reflecting on this? Well, ask anyone who has been through the process; it is an emotional journey. Being offered the award is immense, but rejection can have a huge impact too that really tests your resilience – just something to be aware of and to recognise if you do, or have felt like this then you are not alone.

The place

Eighteen months prior to the award of my fellowship, I had successfully applied for a permanent position at Keele. This was helpful because of Keele's track-record and research focus. It was also helpful to be around others that have trod this path before me. To be at Keele I have moved my family from our original home in Yorkshire to be closer to work because the five hour commute just wasn’t sustainable. With three children of and approaching high-school age, this is not a decision taken lightly and I have often reflected that there is a selfishness to this. But, without the move, I am not confident that I would have been successful with the fellowship or even currently have an academic position. Again, why am I saying this? Well, the place is important; to develop you need to be in the best place possible so this needs careful thought and, unfortunately, might not always be the most convenient place.

The supervisors/ mentors

Who do you want to be like? Who is an expert in your chosen area? Who has experience of these NIHR fellowship programmes? These are good starting questions when thinking about the team you want around you to support you on this journey. Aim high and also think international.

I feel very fortunate to have the mentor team I do; Professors Nadine Foster, Amar Rangan, David Beard and Dr Julia Wade who have all already contributed in their own way. It is helpful to identify these people and get them involved as early as possible.

But, as well, don’t forget a very important group of supervisors/ mentors – the patients who the research will affect! Establishing a working relationship with patients and engaging with them in this process is immensely helpful, just make sure this is on your initial plan and not just an after thought!

The project

Most often I am approached by physiotherapists interested in applying for a doctoral fellowship; this is to be expected given my background and fellowship experience. These conversations often begin along the lines of; ‘I’ve got a great idea for a research project, I want to see if this muscle contraction is better than that muscle contraction for this condition that I’m really interested in.’ Of course, it is fine to start thinking in this way but you need to think strategically with reference to your project. Is this research idea just important to me, or would a national funder see this as an important research question that has a clear pathway to patient benefit. Often this means, for now at least, that you might not be able to follow your initial path; be open to this and let your idea(s) evolve as you engage with all the relevant stakeholders, e.g. priority setting groups, patients, colleagues, mentors/ supervisors and the funder.

But, of course; a fellowship is not an award to undertake a research project in isolation. So, you need to be thinking about how the project offers the opportunity to facilitate your development. The research project in my fellowship is a pilot trial exploring the feasibility of undertaking a larger randomised controlled trial that would compare surgery with a programme of physiotherapist-led exercise for traumatic tears of the rotator cuff. Some of the feedback that I received questioned how this project would facilitate my development as a future leader of NIHR research given that I had already led randomised controlled trials. My argument was that this will be a bigger, more challenging and complex study than I have led before, and will be complemented by other important investigations to determine feasibility (The Quintet Recruitment Intervention – Google it, very interesting) which I don’t have prior experience of. Also, the research aligns with my bespoke training programme that includes development as a leader, design of efficient randomised trials and the Quintet Recruitment Intervention. The research also provides a vehicle for me to engage with my expert mentor team which I see as a key component of my fellowship.

The training programme

I realise I’ve written too much already for the purpose of a blog so I’ll keep this penultimate section brief. It is somewhat ironic that the training programme is the last section because in the context of a fellowship this absolutely should not be the case. Fellowships provide significant opportunity to access training, in various forms, that you would typically not have access to outside of a fellowship. Think carefully about your development needs and how these link to your proposed research. For me, the most helpful think I did was to reach out to other fellowship holders to ask about their training plans and this really helped to begin to develop my ideas.

The process

Depending upon the fellowship scheme, you will likely submit an initial application that will then be scrutinised and, if short-listed, then be invited to submit a full application followed by an interview. The application process is detailed on the NIHR website so I just want to dedicate these last few words to the emotion of the interview. I prepared by reading and re-reading my application, discussing my application widely with clinical and academic colleagues and then having two mock interviews; one at Keele and one in Bristol. But, nothing quite prepares you for the day; facing 16 to 20 very clever people means that you will never anticipate the questions they ask. Following the expected five minute presentation, my opening question from the interview panel was, ‘so how does physiotherapy actually work?’ Wow, big question – wasn’t expecting that! After 20 to 25 minutes of questions from a range of clinicians, methodologists and patients you are excused and enter no-mans land – six weeks of waiting until you hear the outcome. This is a difficult time because the award means so much and I also felt that I could have done better, so was disappointed in myself. I had no clue how to answer one of the questions but felt I should have known; I stuttered for a little bit and then just admitted ‘I’m sorry, I don’t have a credible answer for you.’ I googled it as soon as I got out of the interview which made me feel even worse!

When the e-mail informing me of the outcome dropped in to my inbox, and I read the first line I genuinely cannot describe the feeling. I was working at home and my eldest son was kicking a ball in the back garden. I had to tell someone and he was the closest. ‘I got the fellowship’ I stuttered, he looked at me blankly ‘does that mean you’ll get more money?’ ‘No, son’, I said, ‘but I’m still very happy’ as he started kicking his ball again. Life goes on…

As is often the case, I could write much more…but I’ve got a fellowship to complete, so hope that some aspects of my ramblings were useful to those of you who made it this far.

Chris Littlewood (October 2018)

The SELF managed exercise programme

A few years back I reported the design, development and evaluation of a SELF managed exercise programme for rotator cuff tendinopathy here, here and here. The programme was based on the work of others, including McKenzie & May, and evolved through learning from systematic reviews (here, here and here) and a whole bunch of other literature summarised in my PhD thesis here.

The SELF managed exercise programme involved prescribing just one exercise in relation to the most painful shoulder movement and progressed over a minimum of a 12-week period guided by the symptom response, i.e. exercise should be acceptable to the patient while doing the exercise, immediately after the exercise, and 24-hours later (no use of visual analogue scales and terms such as 3, 4 or 5/10 and no time frame, i.e. it's ok providing the symptoms settle within 24 to 48 hours etc).

The SELF managed exercise was prescribed in relation to what was described as a self-managed framework including helping the patient to understand their problem along the lines of; 'this is a problem with the muscles and tendons of your shoulder, they're lacking fitness, capacity, strength' (limitations of this explanation recognised but aiming to do no harm and provide an understanding that facilitates engagement with exercise). Time is spent in the clinic with the patient practising their exercise so they feel confident to do this independently (more on this later); exercise prescription is supported with an exercise diary and used as a basis to discuss exercise adherence in subsequent follow-up sessions; goals are set using the Patient Specific Functional Scale as a guide; questions are asked about when the patient will fit the single exercise in to their daily routine before a schedule for further follow-up appointments, if required, is agreed.

Recognising that many people with this type of shoulder pain complain of abduction related pain, abduction was used as an example to guide how the SELF managed exercise would be initially prescribed and progressed in previous reports. But, it seems this has been misinterpreted by some and the SELF managed exercise programme has been seen solely an abduction loading programme; it isn't.

The single exercise programme is initially directed towards the most painful or problematic shoulder movement which could be abduction but could also be reaching up to a shelf, bench pressing, serving at tennis, reaching behind etc etc. In the clinic, clues to the most painful or problematic shoulder movement will be gained while taking the history. In terms of the examination, this begins by asking the patient to demonstrate the shoulder movement that most provokes their problem - this is now termed the baseline functional test. Then, movements of the neck are examined to see if they have an effect on the shoulder pain or movement. If they do, and increase or decrease the pain, then it is probably sensible to spend some time exploring the neck a little more before undertaking further testing of the shoulder. If movements of the neck do not influence the shoulder, then the next step is to exclude shoulder pain with stiffness and a simple lateral rotation test is done for this purpose. To confirm the provisional diagnosis of 'rotator cuff tendinopathy' resistance is then applied to the baseline functional test in the pre-symptomatic range, e.g. inner-range flexion if reaching to a shelf is a problem, with the aim of reproducing the familiar shoulder pain. If this test is positive then the next stage of the examination is initiated which aims to identify the type and dose of exercise to be prescribed.

So, for example, if reaching forward to a shelf over 90 degrees is problematic then the movement is broken down and testing could begin with isometric flexion in a step-stance position (to mimic the functional movement as far as possible). The response to 3 sets of 10 isometric flexions is examined remembering that the symptom response should be acceptable during and after and this will vary between patients. If a pain response is not acceptable to the patient then quite simply you wouldn't provoke it. After 3 sets of 10 isometric flexions, if the symptom response is acceptable the next progression could be to isotonic inner-range flexion using theraband or a hand-weight. Again, the response to 3 sets of 10 repetitions is evaluated and if the response remains acceptable then the exercise is progressed further, for example to mid-range flexion with theraband. The aim is to commence an exercise programme that directly challenges the functional problem, so in this case the aim is to introduce loading at 90 degrees of flexion and beyond.

This process helps to identify the type of exercise; begin with the most painful or problematic movement and if loading of this is unacceptable then commence the training with a different movement and return to the most painful or problematic movement when the threat response has reduced sufficiently. This process also helps to identify the dose of exercise; 3 sets of 10 is used as a starting point for the assessment but does not need to be the exercise prescription in all cases. For some, 3 sets of 10 will result in an unacceptable response so a reduced number might be prescribed. For some their functional demand might require higher repetitions so the exercise prescription would reflect this. For some their functional demand might require sustained loading so the exercise prescription would reflect this. In the previous studies listed above, the exercise was prescribed twice per day. Interestingly we still don't know what the optimal frequency is but I think prescribing a programme of this nature and doing it on most days could be a useful starting point.

One clear advantage of going through this process in the clinic is that the patient develops confidence to exercise and has a clear understanding of how to do this but also they are learning how to progress and regress their exercise. So if they want to push on they can begin to understand the principles but equally if the symptom response becomes unacceptable then they know how to regress their exercise, so hopefully enhancing self-efficacy and reducing reliance on the physiotherapist.

The exercise would be progressed over a minimum of a 12-week period based on the symptom response, and using acceptability as the guide. Patients should not begin the 12-week programme with one exercise and end doing the same exercise; progress is expected.

Consider another example; the patient who complains of pain when serving at tennis. The tennis serve could be broken down and testing could begin with isometric medial rotation with the arm by the side. Then progressed to isotonic medial rotation but still with the arm by the side. Then isotonic medial rotation with the arm in 30 degrees of abduction etc etc. Progress is based on acceptable symptom response with the aim of retraining in the zone which is most problematic. This could commence on day one or might take a number of weeks to achieve through the various progressions.

I hope this adds some clarity; no detailed recipes just some guiding principles.

As I mentioned in a previous blog here, there were methodological limitations with the SELF study which means it is not safe to conclude that this approach is better or worse than other approaches at the moment. However, it is an approach that has been developed using existing evidence and is theoretically informed but further evaluation through high-quality, adequately powered randomised controlled trials comparing against other exercise programmes and/ or wait-and-see approaches might be worthwhile to help develop our understanding.

Thanks for making it this far...
Chris

Critical Appraisal of a RCT (June 2018) - Spanish version

¡Amigos! Volvemos con un nuevo artículo para evaluar con el fin de considerar la utilidad al tomar decisiones con nuestros pacientes.

Al examinar la evidencia de la investigación con respecto a la efectividad de los tratamientos, a menudo encontramos mensajes contradictorios y pruebas que apuntan en diferentes direcciones, esto puede ser un proceso confuso.

Esto es especialmente cierto cuando se consideran los problemas que afectan la región del hombro donde las inconsistencias en la terminología y los criterios de diagnóstico para afecciones como el síndrome de pinzamiento subacromial (SAIS) pueden dificultar aún más las comparaciones entre los estudios.  

Bueno, hoy presentamos un artículo de seguimiento con un seguimiento de 10 años que compara un abordaje quirúrgico versus un enfoque conservador en pacientes con SAIS diagnosticados:

La descompresión subacromial produce mejores resultados clínicos que la terapia por si sola: un estudio prospectivo aleatorizado de pacientes con un mínimo de seguimiento de 10 años. Am J Sports Med. Mayo de 2018; 46 (6): 1397-140

Este es un ECA prospectivo con un seguimiento de 10 años, cuyo objetivo fue comparar los resultados obtenidos en pacientes diagnosticados con pinzamiento subacromial tratados con un abordaje quirúrgico de descompresión subacromial (cirugía abierta o artroscópica) o con tratamiento de fisioterapia según el protocolo de Bohmer.

Se reclutaron pacientes con dolor subacromial que persistieron después de la terapia conservadora (fisioterapia no estructurada, antiinflamatorios no esteroideos e inyección local de corticosteroides) que fueron remitidos a un departamento de ortopedia de las unidades de atención primaria. Después de reclutar 95 pacientes consecutivos con SAIS, 87 pacientes cumplieron con los criterios de inclusión y dieron su consentimiento por escrito. Los criterios de inclusión fueron dolor subacromial durante al menos 6 meses. Los criterios de exclusión fueron diabetes mellitus, trastorno neurológico o espinal de cualquier naturaleza, OA radiográfica, la presencia de trastornos articulares crónicos (p. Ej., Artritis reumatoide), ruptura completa del manguito rotador de y SAIS de grado III. 

Los pacientes fueron aleatorizados en 3 grupos utilizando una forma estratificada y ciega (sobres sellados) haciendo ajustes para los factores de confusión identificados por los autores (sexo y edad). Los grupos fueron acromioplastia abierta (grupo de cirugía abierta [OSG]), acromioplastia artroscópica (grupo de cirugía artroscópica [ASG]) o tratamiento no quirúrgico (grupo de fisioterapia [PTG]), los detalles fueron los siguientes

•         Cirugía abierta: el procedimiento se realizó de acuerdo con Rockwood y Lyons

•         Cirugía artroscópica: la descompresión subacromial artroscópica se realizó de acuerdo con Ellman

•         Tratamiento no quirúrgico: el PTG recibió tratamiento de acuerdo con el método descrito por Bohmer

Las medidas de evaluación clínica fueron: puntaje constant, SF-36, puntaje de Watson y Sonnabend, rango de movimiento en términos de elevación activa y rotación interna, y la fuerza en la abducción.

Además, se evaluaron los exámenes ecográficos y radiográficos al comienzo del estudio y durante el seguimiento.

Los autores plantean la hipótesis de que después de 10 años de tratamiento inicial, los pacientes sometidos a acromioplastia tendrían un mejor resultado clínico y un menor riesgo de desarrollar rupturas del manguito de los rotadores y la osteoartritis (OA) en comparación con los tratados con fisioterapia.

Los resultados del estudio durante el seguimiento de 10 años se informan como diferencias estadísticamente significativas a favor de las intervenciones quirúrgicas en las mediciones de rango de movimiento activo, fuerza muscular y puntaje constante. No se encontraron diferencias estadísticamente significativas en los puntajes de Watson y Sonnabend, SF-36, y en las evaluaciones radiográficas y de ultrasonido

Al igual que con muchos estudios, hay limitaciones que deben tenerse en cuenta. Para el propósito de este blog nos enfocaremos en lo siguiente:

1.       Tamaño de la muestra - poder estadístico - desgaste

2.       Diferencia en las características de referencia entre los grupos comparados

Tamaño de la muestra - poder estadístico – desgaste:

Los autores describen en la sección MÉTODOS que "El diseño del estudio se planificó para incluir 40 pacientes en cada grupo de tratamiento" y que "El tamaño de muestra estimado fue de 36 pacientes por grupo", pero luego agregan que "el estudio se cerró después de reclutar a 87 pacientes". (OSG, n = 24, ASG, n = 29, PTG, n = 34) ". En otras palabras, el estudio requería de 108 pacientes para tener un poder adecuado para detectar una diferencia. Los tamaños de muestra pequeños generalmente se asocian con un aumento del riesgo de error de tipo II (no se encuentra una diferencia significativa cuando existe) debido a la falta de poder estadístico para detectar una diferencia. Dado que se encontró una diferencia significativa entre los grupos quirúrgicos y de fisioterapia, esto es menos preocupante en este estudio, aunque en la proyección de 10 años, hubo algunos resultados que no alcanzaron significación, lo que podría explicarse por el pequeño tamaño de muestra.  Como se discutió en un blog anterior (http://research4physiotherapists.blogspot.com/2018/01/critical-appraisal-of-rct-january-2018.html), un tamaño de muestra pequeño no es solo una preocupación desde la perspectiva de la generalización, sino también en relación a hallazgos falsos positivos. Sumado a esto, durante el seguimiento, observamos un desgaste del 38% en el grupo de tratamiento quirúrgico abierto, y un desgaste general del 24,2% de los sujetos del estudio. Esto puede esperarse en un estudio de seguimiento de 10 años, pero estos factores deben considerarse al construir el diseño de la investigación y no se mencionaron estrategias estadísticas para explicar esta tasa de abandono.   

Diferencia en las características basales entre los grupos comparados:

Como hemos visto anteriormente en otras publicaciones de blog (http://research4physiotherapists.blogspot.com/2016/12/the-randomised-controlled-trial.html) una de las formas más seguras de distribuir las características de los sujetos por igual entre los diferentes grupos de tratamientos en estudios de intervención, tanto en características conocidas como desconocidas, es la aleatorización de los sujetos en los grupos de tratamiento. Entonces, a través de las reglas del azar, podemos estar seguros de que los grupos son comparables entre sí y atribuir cualquier diferencia en los resultados a la intervención que se está estudiando. En primer lugar, los autores afirman que los grupos al inicio fueron comparables, sin embargo, en un análisis más cuidadoso, observamos lo siguiente: En la duración de los síntomas de los sujetos asignados a cada grupo de tratamiento, 17 individuos (55%) pertenecientes al grupo de tratamiento conservador mostraron una duración de sus síntomas mayor a 36 meses, más del doble que los 8 presentes en el grupo de cirugía artroscópica, y mucho más alto que el grupo de cirugía abierta (11 personas).   Esto significa que los grupos que se comparan son diferentes incluso antes de que estén expuestos a los grupos de tratamiento. Por lo tanto, no podemos estar seguros de que las diferencias encontradas entre los grupos de intervención quirúrgica y el grupo de tratamiento de fisioterapia a los 10 años no estén influenciadas por estos, y otras diferencias desconocidas.

Conclusiones

Las fortalezas del estudio incluyeron una comparación aleatorizada y un seguimiento a largo plazo. Sin embargo, los resultados deben interpretarse con precaución debido a las preocupaciones sobre el tamaño de la muestra y el riesgo de hallazgos casuales, así como las diferencias iniciales en los grupos de tratamiento en relación con factores pronósticos importantes.

Estos hallazgos también deben considerarse en el contexto del reciente ensayo controlado aleatorio CSAW (https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)32457-1/fulltext ) y una revisión sistemática comparando cirugía con programas que incorporan ejercicios dirigidos por fisioterapeutas (https://www.tandfonline.com/doi/abs/10.3109/09638288.2014.907364) y también otro ECA con seguimiento de 10 años que informó que no hubo diferencia entre la cirugía y un programa incorporando ejercicios dirigidos por fisioterapeutas (https://www.ncbi.nlm.nih.gov/pubmed/28566400). 

 Tomás Parraguez, Brian Cho, Paul Regan, Chris Littlewood, Sijmen Hacquebord

Critical Appraisal of a RCT (June 2018)

We return again with a new article to appraise in order to consider usefulness when making decisions with our patients.

When examining research evidence regarding treatment effectiveness we often find contradictory messages and evidence pointing in different directions, this can prove to be a confusing process. This is especially true when considering conditions affecting the shoulder region where inconsistencies in terminology and diagnostic criteria for conditions such as subacromial impingement syndrome (SAIS), can make comparisons between studies even more difficult.

Well, today we bring up a follow-up article with a 10 year follow-up comparing a surgical approach versus a conservative approach in patients diagnosed SAIS:

Subacromial Decompression Yields a Better Clinical Outcome Than Therapy Alone: ​​A Prospective Randomized Study of Patients With a Minimum 10-Year Follow-up. Am J Sports Med. May 2018; 46 (6): 1397-140

This is a prospective RCT with a 10-year follow-up; the objective was to compare the results obtained in patients diagnosed with SAIS treated with subacromial decompression (open or arthroscopic surgery) or with physiotherapy according to the Bohmer protocol.

Patients with subacromial pain that persisted after conservative therapy (unstructured physiotherapy, non-steroidal anti-inflammatory drugs, and local injection of corticosteroids) who were referred to an orthopeadic department from primary care units were recruited. After recruiting 95 consecutive patients with SAIS, 87 patients met the inclusion criteria and gave their written consent. The inclusion criteria were subacromial pain for at least 6 months. The exclusion criteria were diabetes mellitus, neurological or spinal disorder of any nature, radiographic OA, the presence of chronic joint disorders (e.g. rheumatoid arthritis), full thickness rupture of the  rotator cuff, and SAIS stage III.

The patients were randomized into three groups; open acromioplasty (open surgery group [OSG]), arthroscopic acromioplasty (arthroscopic surgery group [ASG]) or non-surgical treatment (physical therapy group [PTG]). The details of the treatments are as follows:

•         Open surgery: The procedure was performed according Rockwood and Lyons.

•         Arthroscopic Surgery: Arthroscopic subacromial decompression was performed according to Ellman.

•         Non-surgical treatment: The PTG received treatment according to the method described by Bohmer.

The clinical evaluation measures were: The Constant score, SF-36, Watson and Sonnabend score,  range of movement in terms of active elevation and internal rotation, and strength in abduction.

In addition,  ultrasound and radiographic examinations were evaluated at the beginning of the study and during follow-up.

The authors hypothesized that after 10 years, patients who had undergone acromioplasty would have a better clinical outcome and a lower risk of developing ruptures of the rotator cuff and osteoarthritis (OA) compared to those treated with the physiotherapy programme.

The results of the study through the 10-year follow-up are reported as statistically significant differences in favour of the surgical interventions in the active range of motion measurements, muscular strength and Constant score. No statistically significant differences were found in the Watson and Sonnabend scores, SF-36, and in the radiographic and ultrasound assessments.

As with many studies, there are limitations that need to be considered. For the purpose of this blog we will focus on the following:

1.       Sample size - statistical power - attrition

2.       Difference in the baseline characteristics between the compared groups

Sample size - statistical power - attrition:

The authors describe in the METHODS section that "The study design was planned to include 40 patients in each treatment group" and that "The estimated sample size was 36 patients per group" but then they add that "the study was closed after recruiting 87 patients (GSO, n = 24, ASG, n = 29, PTG, n = 34)". In other words, the study required 108 patients to to have adequate power to detect a difference. Small sample sizes are generally associated with an increase risk of type II error (not finding a significant different when one exists) due to a lack of statistical power to detect a difference.  Since a significant difference was found between the surgical and physiotherapy groups, this is less of a concern in this study although in the 10-year projection, there were some results that did not reach significance, which could be explained by the small sample size. As discussed in a previous blog (http://research4physiotherapists.blogspot.com/2018/01/critical-appraisal-of-rct-january-2018.html) a small sample size is not only a concern from the perspective of generalisability but also risks false positive findings. Given the size of the three randomised groups in this RCT this is a concern with  this study.   Added to this, during the follow-up, a 38% attrition was observed in the open surgical treatment group, and an overall attrition of 24.2% of the study subjects. This may be expected in a 10-year follow-up study, but these factors should be considered when constructing the research design and consideration given for strategies to account for missing data.

  

Difference in baseline characteristics between the groups compared:

As we have seen previously in other blog posts (http://research4physiotherapists.blogspot.com/2016/12/the-randomised-controlled-trial.html) one of the safest ways to distribute the characteristics of subjects equally between the different treatment groups in intervention studies, both in known and unknown characteristics is through randomization. So through the rules of chance, we can be sure that the groups are comparable to each other, and attribute any differences in the results, to the intervention that is being studied. In the first instance, the authors state that the groups in the baseline were comparable, however, in a more careful analysis, consider the following: when observing the duration of the symptoms of the subjects assigned to each treatment group, 17 individuals ( 55%) belonging to the physiotherapy treatment group showed a duration of their symptoms greater than 36 months, more than double that of the 8 present in the arthroscopic surgery group, and much higher than the open surgery group (11 people). ). This means that the groups that are compared are different even before they are exposed to the treatment groups. Thus we cannot be  sure that the differences found between the surgical intervention groups and the physiotherapy treatment group at 10 years are not influenced by these, and other unknown, differences.

Conclusions:

The strengths of the study included a randomised comparison and longer-term follow-up. However, the results should be interpreted with caution because of concerns about the sample size, and risk of chance findings, as well as baseline differences in the treatment groups in relation to important prognostic factors.

These findings should also be considered in the context of the recent CSAW randomised controlled trial (https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)32457-1/fulltext) and a systematic review comparing surgery with programmes incorporating physiotherapist-led exercise (https://www.tandfonline.com/doi/abs/10.3109/09638288.2014.907364) and also one other RCT with 10-year follow-up that reported no difference between surgery and a programme incorporating physiotherapist-led exercise (https://www.ncbi.nlm.nih.gov/pubmed/28566400).

Tomas Parraguez, Brian Cho, Paul Regan, Chris Littlewood,  Sijmen Hacquebord