Ep 207: The intervention effect or the vibe? With Dr Giacomo Rossettini

[00:00:04] Hello and welcome to JOSPT Insights, the podcast that aims to help you translate quality research to quality practice. I'm Claire Ardern, the Editor-in-Chief of the Journal of Orthopedic and Sports Physical Therapy. It's great to have you listening today.

[00:00:22] So when our patients improve, how much of that is because of what we did and how much of it is due to contextual factors and nonspecific effects that lie outside of our control.

[00:00:31] Today we are joined by Dr Giacomo Rossettini, author of the recent paper entitled, Which Portion of Physiotherapy Treatment's Effect is Not Attributable to the Specific Effects in People with Musculoskeletal Pain? A Meta-Analysis of Randomized Placebo Controlled Trials.

[00:00:45] Dr Giacomo Rossettini is a physiotherapist and researcher from Italy. He completed his PhD in Neuroscience in 2018 and has been a treating physiotherapist since 2009.

[00:00:55] He currently works at the Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics and Maternal Child Sciences within the University of Genoa, where he performs research related to orthopedic surgery, physiotherapy, sports medicine and allied health sciences.

[00:01:08] My name is Dan Chapman. I'm the owner of Summit Physical Therapy in Baltimore, Maryland.

[00:01:13] Dr. Rossettini, thank you so much for coming on the show again to share your time, your effort, your knowledge, your expertise with all of our listeners.

[00:01:23] Thank you. Thank you for the invitation.

[00:01:25] What was the motivation behind looking at specific and nonspecific effects and all that fun stuff that's really hard to do?

[00:01:32] When we decided to start with this systematic review with meta-analysis, we moved from the clinical questions that every day live in the clinical practice.

[00:01:43] Because the premise is that when we apply, for example, a manual therapy techniques or a therapeutic exercise, we know that it works well with our patients with musculoskeletal pain.

[00:01:55] But when we started, we were interested to understand the amount of specific and nonspecific effects that justified what we observed in terms of improvement.

[00:02:09] The motivations arise from the clinic.

[00:02:12] Okay, so you're basically saying, hey, I know what I'm doing with this patient is working.

[00:02:17] They are getting better.

[00:02:18] But I want to find out how much of it is because of what I am doing.

[00:02:22] So let's just say this lumbar manipulation or these exercises or these low back mobilizations or soft tissue or dry needling or what have it.

[00:02:30] So let's just say this.

[00:02:31] So let's just say, how much of it is.

[00:02:33] How much of it is either the things that I can't control like natural history or some other sort of nonspecific effects.

[00:02:42] Yes, when we started, we aim to quantify the proportion or attributable to the specific effects of the different physical therapy interventions for musculoskeletal pain.

[00:02:53] During this journey within the research, it was really nice to become aware that the amount of nonspecific effects is really large and can influence the effects of what we every day apply in our clinical practice.

[00:03:10] And that's, I think, one of the most surprising results.

[00:03:14] For our listeners who might not know exactly what is a specific effect versus a nonspecific effect, can you go into that a little bit and then also just give us some examples again for our clinicians of what might be a specific effect and what might be a nonspecific effect in a clinical setting?

[00:03:31] When we consider the outcome of the treatment, it is a result of specific effects derived from the intervention itself, such as a manual therapy techniques or therapeutic exercises.

[00:03:44] And also nonspecific effects that is an umbrella term so that encompass different elements such as the open effect, the natural history, the regression to the mean and also the contextual factors.

[00:03:57] And both the dimensions, the specific and non-specific, interacting with each other can modulate and explain the overall therapeutic outcomes and the overall therapeutic effects that we observe within the randomized controlled trial, of course, but also within our clinical practice.

[00:04:16] Okay.

[00:04:17] And so just to kind of flesh those out a little bit more, I think you mentioned the Hawthorne effect.

[00:04:21] Is that right?

[00:04:23] Yeah.

[00:04:23] So that's kind of the idea that there might be some human behavior or reactivity that occurs when people are aware that they are being observed.

[00:04:31] Is that accurate?

[00:04:32] Yeah, it is.

[00:04:34] Great.

[00:04:34] And then we have the idea of natural history.

[00:04:37] And so somebody getting better on their own without us working with them at all.

[00:04:41] And so how that factors into the clinic is that we see them getting better as we work with them.

[00:04:45] But some of that is actually just them getting better as they would anyways.

[00:04:49] And then there are other non-specific effects such as, okay, it might be the therapeutic alliance between the patient and the clinician or simply just the act of me touching my client.

[00:05:03] Right.

[00:05:04] And not actually the specific effect that I'm going for, like a low back mobilization or a manipulation to the spine or the dry needling, but actually just me making physical contact with their body has a non-specific effect, which is going to help them.

[00:05:21] And that itself is separate from what I am actually trying to do with my manual therapy technique.

[00:05:28] Is that accurate?

[00:05:29] Yeah, it is.

[00:05:31] It is nice to see that these two dimensions that describe the overall therapeutic outcomes are really influencing each other during the administration of the treatment.

[00:05:44] So within the clinical practice, where we manage the treatment and we administer the intervention with our patients, we cannot separate them because when we administer the specificity of the treatment, always there is a human contact, a contextual dimension.

[00:06:04] And also there is a human contact, and also there is a human contact with our patients, and also there are regressions in the mean and the natural history of the disease.

[00:06:09] We cannot separate it within the clinical encounter.

[00:06:12] We know it.

[00:06:13] But what we have tried to do with this meta-analysis is try to observe and quantify the proportion attributable to the specific effects compared to the non-specific effects.

[00:06:27] We aim to observe these dimensions from a scientific perspective.

[00:06:34] We all went through a lot of studies.

[00:06:38] I believe there are 68 studies that were included, 54 of them were placebo-controlled trials.

[00:06:44] How do you as researchers try to separate out the specific from non-specific effects?

[00:06:51] Our approach aims to clarify the relative contributions of the specific treatments, effects, and the non-specific effects.

[00:07:01] And we estimate how much the treatment outcome can be attributed to the factors behind the specific therapeutic interventions.

[00:07:09] Within this meta-analysis, we adopted a matrix that was named as PCE, proportion of contextual effects that also encompass all the dimensions of the non-specific effects as well.

[00:07:25] And these elements, these metrics, offer us two values that range from 0 to 1, indicating the 0% contribution from factors not related to the intervention itself.

[00:07:47] We have these two values that we should consider.

[00:07:51] We use and we adopt this metric for two main reasons.

[00:07:54] The first one is that was largely adopted within the research and the evidence, because we have other examples in literature that have just applied these metrics, for example, to quantify the non-specific dimension in osteoarthritis and those in fibromyalgia.

[00:08:13] These are only two examples.

[00:08:15] And the second reason was that there were not randomized controlled trials composed by three arms.

[00:08:25] To quantify the specific and non-specific effects, we should have a randomized controlled trial composed by three arms.

[00:08:32] An active treatment, a placebo treatment, and a wait-and-see group.

[00:08:37] And this is the goal standard to assess the specific and non-specific contribution.

[00:08:43] And also within the non-specific contribution, to observe the contextual dimensions compared to the other dimensions, such as the natural history of the disease and the regression techniques.

[00:08:53] However, such trials are arranged in physical therapy, often due to the ethical concerns when including a non-treatment.

[00:09:02] So for that reason, we adopt this and be aware that this is not the, and this was not the gold standard, but this is only a strategy that offers us the possibility to introduce a discussion on this topic.

[00:09:17] That is not the final word, but it is the first step that should, I think, encourage all the scientific communities and clinicians to see and to conceive what we do every day in clinical practice composed by different elements.

[00:09:34] Okay, so to summarize, let's just say I have a patient who comes into the clinic with low back pain.

[00:09:40] We get them 90% better over the course of six weeks, and we did lumbar manipulation, soft tissue work, dry needling, and a whole bunch of physical exercise.

[00:09:49] We want to know how much of that was, how much of that improvement was actually due to the specific techniques and exercises that I put this patient through.

[00:10:00] And then how much of that 90% was due to the non-specific effects?

[00:10:06] So again, either the Hawthorne effect, natural history, regression to the mean, and then other non-specific contextual effects that we've been talking about.

[00:10:13] When we observed the results of our systematic review, we were surprised because a large amount of the overall therapeutic effects was described by the non-specific dimensions.

[00:10:27] So there is a specific dimensions, of course, but also the non-specific dimensions matters.

[00:10:35] And I think that as a clinician, we should be aware that when we apply hand-hand-hand techniques, such as manual therapy, spinal mobilization, joint manipulation, or soft tissue techniques,

[00:10:49] but also when we apply hand-hand and soft tissue techniques, such as therapeutic exercises, we should be aware that every time the specificity of what we do strongly interacts with the non-specific dimension, we cannot eliminate it.

[00:11:05] We should accept it, and when possible, try to emphasize also the use of this non-specific dimension.

[00:11:13] Because at the end, what we really want is that our patients improve.

[00:11:18] We have strong evidence-based treatments, and when we apply it, we should be aware that they work using specific mechanisms, but also non-specific ones.

[00:11:29] And the combination of both could help us to explain why the patients improve pain and disability, for example.

[00:11:37] The results from our systematic review observes a large amount of non-specific effects for the different techniques when we consider pain as an outcome, but also disability.

[00:11:49] Let's just dive into some of the numbers here for our listeners that might be wondering, okay, just how much of a percentage did the non-specific effects take?

[00:11:59] I love how you also separated this into immediate short-term and long-term effects.

[00:12:04] For example, when we try to have a look at the immediate effects and we consider dry needling, for example, the 74% of the total therapeutic outcome could be explained by the non-specific dimensions.

[00:12:22] But also, when we deal at the immediate effects and we describe the manipulation, we have the 71% of the effects explained by the non-specific dimensions.

[00:12:33] When, for example, when we describe the use of soft tissue techniques, we can use the non-specific dimensions to explain the 81% of the overall therapeutic outcome.

[00:12:43] The numbers are very, very large, but they help us to understand that it is not only a matter of specificity.

[00:12:52] It exists, it is important, but also other dimensions matters.

[00:12:59] Absolutely.

[00:12:59] Yeah, I don't think the takeaway of this is that nothing we do matters and the points are all made up.

[00:13:05] There are specific effects from the techniques that we're implementing on our patients, but there are also non-specific effects.

[00:13:12] And we shouldn't shy away from that because that's still patient improvement.

[00:13:16] At the end of the day, it's still the patient coming into your office and leaving and getting better.

[00:13:21] And I think the way that you phrased it, I really like, I think you said, it's evidence-based.

[00:13:26] If someone asks you, why are you doing the low back mobilization?

[00:13:31] You can say, this is evidence-based to decrease your pain and disability.

[00:13:36] That is evidence-based to decrease your pain and disability.

[00:13:39] We see it right here.

[00:13:39] It's a mixture of specific and non-specific effects, but it doesn't restrict you as a clinician.

[00:13:46] It doesn't prevent you from doing any of these techniques because, again, they're shown to help.

[00:13:51] It's just the makeup of what goes into it may be different than we may have previously thought.

[00:13:56] You have introduced one of the most important findings and I hope take a take-home message of this paper.

[00:14:06] The existence of these non-specific effects should not justify the pseudoscience.

[00:14:14] We apply as healthcare providers the best evidence-based treatments, following the guidelines and also the scientific knowledge.

[00:14:23] Through this application, we can have an improvement in terms of pain and disability with patients with musculoskeletal pain.

[00:14:32] We cannot change this element.

[00:14:34] It is important to follow the best practice.

[00:14:37] But I think that this systematic review could inform us that when we apply the best evidence,

[00:14:44] the effects that we observe in our patients at the end of the day could be explained not only by the specificity of what we do,

[00:14:54] but also by the non-specific dimension that encompasses several factors,

[00:15:01] such as contextual dimensions, contextual factors, for example,

[00:15:05] but also the other elements such as the natural history and the reverberations to the mean.

[00:15:10] We should be aware and accept it and use the techniques and the therapeutic strategies with more awareness

[00:15:19] to help our patients every day in the clinic.

[00:15:23] I think that the paper doesn't suggest to avoid evidence-based practice.

[00:15:29] Instead, it helps the clinicians to apply the best evidence with more awareness.

[00:15:35] Yes.

[00:15:35] We're trained to improve our specific effects as best as we can, right?

[00:15:40] Through training in school and continuing education and hands-on techniques.

[00:15:44] I don't know of any continuing education that helps you improve your clinical non-specific effects, right?

[00:15:50] You know, I had to ask because I'm curious if there was anything that came out of this that said,

[00:15:54] okay, this is what we should be doing or consideration for trying to improve our non-specific effects.

[00:16:01] Some elements of the non-specific dimensions.

[00:16:05] Of course, we know that the regressions to the mean and the natural history of the disease

[00:16:10] is outside of the control of the clinicians.

[00:16:14] But clinicians, of course, could be aware about this and monitor the progress of the patients

[00:16:21] and continue to investigate and study, for example, the prognosis or the natural course of the disease.

[00:16:29] But there is another factor within the non-specific dimension that is represented by the contextual dimensions,

[00:16:37] of course, the contextual factors that can be used by the clinicians when they apply the hands-on and soft techniques.

[00:16:46] So, for example, when you are using manual therapy techniques such as joint mobilization or spinal manipulation,

[00:16:54] when you administer it, remember that you can use the right words with your patients.

[00:17:00] You can manage the patient's expectation, consider the patient's previous negative or positive experience with those techniques, of course.

[00:17:10] And also remember that the rituals, the rituality encapsulated within the treatment can influence the therapeutic outcomes.

[00:17:19] So, I think it is natural within the clinical practice to administer techniques and boost it using all the dimensions of the context.

[00:17:29] Of course, we cannot use only a single dimension of the context, for example, the words.

[00:17:34] But when we administer treatment, every time there are a strong relationship between what is the words,

[00:17:44] also the rituality, the rule of touch, the engagement of the patient, the therapeutic alliance,

[00:17:51] and all these dimensions can be used to boost this dimension of the non-specific effects.

[00:17:59] There are non-specific effects that you can't control, necessarily like regression to the mean or natural history,

[00:18:05] but there are the non-specific effects that you can control, like the contextual factors that you talked about.

[00:18:11] And they don't need to be necessarily separated between specific and non-specific because, for instance,

[00:18:16] an example might be that the more that I train my specific techniques, right?

[00:18:22] A specific being in quotation marks, the more comfortable and confident I am going to be.

[00:18:28] And that confidence and comfort is going to carry over to the therapeutic alliance with the patient in front of me

[00:18:34] and make them more comfortable and confident, which is going to help the overall outcomes,

[00:18:38] which is an argument to say that we need to be practicing our specific techniques,

[00:18:44] if only to harness and improve our non-specific outcomes.

[00:18:48] And we've all been there, right?

[00:18:50] When you first do a spinal manipulation or you first do a joint mobilization and you're in school

[00:18:54] and you're nervous and you're trying to explain it to the patient and you just see that your patient does not believe

[00:19:00] that you know what you're doing, and that might actually have some effects on your overall outcomes.

[00:19:07] Not necessarily because you did the actual thing wrong, but because of the non-specific contextual effects that you conveyed.

[00:19:15] And so I just, you know, I love the study because of all these different things that factor into it.

[00:19:21] When you have the possibility to train on specific elements such as spinal manipulation or drain needling during the weekend

[00:19:29] and you came back to the clinic on Monday, all the patients improve using these techniques.

[00:19:35] It could be explained because you have trained the specificity of the techniques, of course,

[00:19:40] and when you administer it, you have a rituality that encompasses a strong message of professionality on the eyes of our patients.

[00:19:51] And this could help to boost the overall therapeutic outcomes.

[00:19:54] All the clinicians and researchers that read this paper and treat patients could understand the key message that we wanted to share with us.

[00:20:09] Couldn't agree more.

[00:20:11] The most important message is that what we do should be evidence-based.

[00:20:17] You all did phenomenal work.

[00:20:19] You obviously have an amazing team that you're working with.

[00:20:22] Thank you so much for the time and effort that you put into this paper.

[00:20:26] Thank you so much for coming on the show and sharing your time and expertise with our listeners.

[00:20:30] Thank you so much.

[00:20:31] Have a good day and have a good read.

[00:20:34] Once again, we want to thank Dr. Rosettini for coming onto the show and sharing his time and his expertise with us and you.

[00:20:41] And as always, we want to thank you for listening to JOSPT Insights.

[00:20:48] Thanks for listening to this episode of JOSPT Insights.

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