Pain Management – it’s a sham

If we posit that pain is an output of the brain that is based on the perception of threat, it would follow that decreasing threat, whatever it may be, would positively influence a person’s pain experience. This has led to some exciting therapeutic advances aimed at altering threat, which include encouraging patients to rewrite their pain experience using a biopsychosocial model of their pain, educating patients about the neuroscience of pain, and teaching them about body representations.

Seven years ago, our research team, led by Adriaan Louw, embarked on a series of studies aimed at developing a preoperative neuroscience education program for lumbar radiculopathy. The series was underpinned by a general theme of teaching patients about the neurophysiology and neurobiology of pain before surgery, so that when they experienced pain after surgery, they were expecting pain, they had the capacity to “embrace it” and to make healthier choices regarding their postoperative pain. An example of such healthier choices would be moving on and improving their functional abilities, despite the presence of pain; that is, that pain is normal. We would then compare them to patients not receiving preoperative neuroscience education on outcomes such as pain, disability, healthcare utilization and thoughts/ beliefs about their surgery. We did, however, have to “tip-toe” around the general idea of not trying to talk patients out of undergoing surgery…otherwise, no surgeons would consent. We felt deeply that the “holy grail” would be to teach patients getting ready for surgery so much about their pain that they would believe they might not need the surgery. And it was within this concept of empowering the brain, that we stumbled upon and revisited a very powerful issue: sham surgery. Sham surgery could be seen as the ultimate “brain trick”, when it comes to intervention, and powerfully underscores the idea that when the brain believes the treatment/surgery has minimized or eliminated a particular problem, pain and disability eases.

In 2011, we started looking into randomized controlled trials involving sham surgery. The most cited study at that time was by Moseley, JB et al on sham debridement for knee OA, but few other studies were well known. A preliminary search revealed that sham surgeries had been investigated for various medical conditions, including ligation of the internal mammary artery, Parkinson’s disease, and Meniere’s disease. In line with our interests at the time, we decided to complete a systematic review of sham surgery in orthopedics. After extensive searches, we ended up with only 3 studies. Two were on vertebroplasty for back pain[1,2] and the other was the sham debridement for OA knees by Moseley.[3]

The systematic review was completed in 2012 and we presented the findings at various conferences. It caused a significant “buzz” and our next thought was to get it published – but who, we wondered, would ever accept it for publication? We started with a series of high ranking orthopedic and medical journals. Needless to say, rejections came thick and fast and when the manuscript actually went out for review, it was obvious that reviewers wanted to reject the ‘idea’ as much as the manuscript. With each rejection and when reviewers gave constructive criticism, we reworked the new manuscript for resubmission and in fairness, in some cases it did help with the narrative. In the meantime, additional sham surgery studies were discovered and added to the systematic review. The final published review[4] included six randomized controlled trials (RCTs) involving 277 subjects. All six studies were rated as very good on methodological quality. Heterogeneity across the studies, with respect to participants, interventions evaluated, and outcome measures used, prevented meta-analyses. Narrative synthesis of results, based on effect size, demonstrated that sham surgery in orthopedics was as effective as actual surgery in reducing pain and improving disability.

Sure, there is a lot of controversy surrounding sham surgery with proponents and opponents, as expected. The concept of “useless” surgery has been trending on twitter over the past few days, after an article was published in the New York Times by Gina Kolata. The article included comments from one of the authors of a sham study included in our review, Dr. David Kallmes. For us, publication of the review is very important and we hope it can be viewed from the vantage point of tapping into the enormous potential of the brain and a human’s pain experience. From our point of view, we see sham surgery much like mirror therapy, virtual reality, etc., as a means to alter the perception of threat, although admittedly, surgery is a much more expensive, invasive and risky “trick.” It is also imperative that everyone realizes the review focused on the sham vs real surgery effects on pain and disability, and not on whether neurological deficits or other serious medical issues were restored. Surgery and the powerful rituals surrounding it are likely to involve a powerful placebo response. It reminds us of a quote by Mick Thacker: “The more powerful the procedure, the more powerful the placebo”. We’re happy to finally get this review “out there” and hopefully stir some thoughts, opinions and emotions, and generate additional and much needed dialogue in a an area of pain management that is in need of major revamping, certainly from a pain science perspective.

About Louie Puentedura

Louie_PuenteduraDr. Louie Puentedura is an Associate Professor at the University of Nevada Las Vegas, USA. He began his career as a manipulative physiotherapist in Melbourne and Ballarat, Australia in the early 1980’s and after 15 years of clinical experience moved his family to the USA and completed a post-professional Doctorate in Physical Therapy at Northern Arizona University in 2005 and a PhD at Nova Southeastern University in Fort Lauderdale, Florida in 2011. His research interests involve the safety and effectiveness of spinal manipulation, and in combining manual therapy with pain neuroscience education in clinical practice.

References

[1] Buchbinder R, Osborne RH, Ebeling PR, et al. A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures. N Engl J Med. 2009;361(6):557-568.

[2] Kallmes DF, Comstock BA, Heagerty PJ, et al. A randomized trial of vertebroplasty for osteoporotic spinal fractures. N Engl J Med. 2009;361(6):569-579.

[3] Moseley JB, O’Malley K, Petersen NJ, et al. A controlled trial of arthroscopic surgery for osteoarthritis of the knee. N. Engl. J. Med. 2002;347(2):81-88.

[4] Louw A, Diener I, Fernandez-de-Las-Penas C, Puentedura EJ. Sham Surgery in Orthopedics: A Systematic Review of the Literature. Pain Med. 2016.

Comments

  1. Dr. Puentedura, I think that what is very important that Adriaan and you do in your pre-operative teaching is highlight that pain post surgery is normal and to embrace the pain and move forward. Much easier said than done however you provide excellent tools for others to follow.

    The pictures of alarm bells (in a ‘normal’ state and an ‘excited’ state) and the baseline of neural ‘noise’ that is present all the time are extremely helpful and make sense to people.

    Frances, I realize that Dr. Ian Harris’ book is excellent and as an orthopaedic surgeon, his questions and demand for evidence is illuminating. Most of the older surgeons I work with are very sensible in their approach – we have Explaining Pain classes that are free to attend that provide 2 – 4 hours of instruction (in multiple languages). Understanding pain prior to surgery is key. However, it is not what we say to people but what they take away. HealthChange methodology approach is very important.

    Sometimes I get the sense from BIM posts that pain as a ‘conscious correlate of the implicit perception of threat to body / tissues’ is mostly a matter of feeling safe and the pain will go away whether acute – persistent or entrenched (I realize I am generalizing). It is a powerful meme and very important.
    Sometimes, consciousness seems equated only with cortex activity and that pain is ‘encased’ in the cortex – neurotags and neurosignatures appear to be scratched on the surface. Again, I realize I am not painting the best picture. Any help?

    Another excellent book is ‘The Laws of Medicine – Field Notes from an Uncertain Science’ from Siddhartha Mukherjee which highlights that ‘normals’ teach us rules; ‘outliers’ teach us laws. The work of Dr. Adahan from Israel on patients with phantom limb pain (PLP) in which he used local anaesthetic on the DRG with patients and achieved prolonged resolution of PLP and more ordered somatosensory experience highlights the importance of ‘bottom-up’ processing and feedback / forward loops and also that there are ‘layers’ to consciousness. Again, I realize most people know this. Dr. Ramchandran used to say PLP was ‘mostly central processing’. I have others tell me that this or that pain is ‘mostly peripheral.’ Perhaps we could have more discussions about defining processing / adaptation and whether language needs to change as part of a continuum.
    Any help?

  2. Frances, thanks for the update. Although I really appreciate this discussion and the insight it has provided, I am troubled by the either / or thinking in ‘Surgery the ultimate placebo’. I agree with Mick Thacker’s comments (or past comments) on the ‘stronger’ the intervention, the ‘stronger’ the placebo effect (or nocebo effect) however I think there may be confusion re the neuromatrix and the collagen matrix.
    I believe that the ‘best’ definition of pain (for me) is the conscious correlate of implied perception of threat and that the experience of pain is primed in defensive peripersonal space.
    I think the second part of this sentence has been enlightening.
    I am still learning (profess to ignorance most days).

    However, having worked with patients with rheumatoid arthritis many times in my career, I have seen a great shift in practice since introduction of biologics and assertive / aggressive early intervention. I remember reading in Explain Pain (I believe), the close relationship between pain and inflammation in RA and I agree.
    I also agree that OA is much better understood with modern neuroscience and the interaction between neurological / immunological factors. Tasha Stanton’s work is enlightening.
    It was Michael Shacklock in the mid 90’s who discussed the ‘container concept’ and the close interaction between musculoskeletal system and nervous system. Dynamic systems.
    Creating space within these dynamic systems is important.
    This seems to be lost in this discussion. Pre surgical cases in which there is little space for movement of tissues / nerves with contracture and poor movement patterns who have not returned to meaningful function may need surgical intervention. Early in my career, I was amazed when perceived contracture would ‘resolve’ under general anaesthetic however not that often. Exploring person’s emotional trauma and helping with integration is important however in most cases with contracture and altered movement patterns, is it the answer? It may help their pain but can you recreate the space necessary to return to meaningful function?
    I question the logic. I am seeking insight / understanding.
    Thanks for help of BIM.

  3. Frances Black says:

    you need the read the book
    “Surgery the ultimate placebo” by Ian Harris
    then you will be convinced

  4. Dr. Puentedura, I have been very impressed with your work and the work of Adriaan Luow in helping people with understanding pain. The research work on Therapeutic Neuroscience Education (structured tools / diagrams / pictures and text) are extremely helpful. From what I remember with the research that was done on Therapeutic Neuroscience pre lumbar radiculopathy was that patients 1 year post had better understanding of pain and less persistence than those who did not receive the education. My question is, how has your work expanded? Has it resulted in better pre-surgical support for patients in Nevada in understanding pain / persistent pain?
    I am very interested in the knowledge translation piece and cultural shift. I would appreciate your insight.

    Louie Puentedura Reply:

    Thank you for your kind words, Stu. The study Adriaan completed on Pain Neuroscience Education (PNE) pre lumbar radiculopathy found that the experimental group (that received 30 minutes one-on-one pain science education) had similar outcomes in terms of back pain, leg pain, disability, etc. but spent significantly less $$ on healthcare one year after their surgery. We have data from 3 years after surgery, and their spending on healthcare remained lower than the control group. What I find remarkable was that it was after only 30 minutes of one-on-one education. Because of the approved study design, we could not control for whether or not each patient had post-op physio/ rehab. I wonder what we might have found if the experimental group got PNE-based post-op rehab versus the control getting no PNE and an anatomically-based post-op rehab program….
    We are currently looking at the effect of pre-op PNE in patients undergoing total knee replacement, but as with the original study on lumbar radiculopathy, the experimental group get a 30 min PNE session as well as usual pre-op education about their knee replacement surgery. Hope to have data analysed on that study by early next year.
    On the question of knowledge translation, I think we are seeing a paradigm shift amongst physios working in the trenches. They are finding out about the importance of explaining pain to their patients, and seeing a difference in their clinical outcomes. Of course, this is all anecdotal at this point – evidence in the form of clinicians relaying this at seminars and conferences. It would make a great study to actually measure the translation piece!

  5. alex chisholm says:

    This is truly fascinating. Is this article ahead of print? I had trouble finding the review. Thank you again to this research group….i

  6. Monica Thomas says:

    I have to be honest and simply write that at this point, I give little to no credibility to the NY Times article. Clearly, the author, Gina Kolata, was not thorough or is simply ignorant. Just reading the abstract linked to the second blue/underlined word, “conclusions,” it is clear that journalistic integrity has gone out of the window. The systemic review does not even use research “appropriate” wording. And, comparing randomized trials of participants with received spinal fusion due to chronic lumbar pain associated with disc degeneration to participants with nonspecific pain….absurd. The Cochrane Review would have been a much better option. I have chronic lumbar back pain not due to disc degeneration, for which surgery and opiods are not an option and which CBT for fear of back pain is not helpful. And, I should know as a psychotherapist for over 21 years (I am not suggesting that CBT is not helpful – just not for me). At the same time, I do think that physicians do have the responsibility of knowing current research of particular surgeries (RTC studies) and should only put surgery on the table when all other options have been exhausted, including a holistic approach to treatment, and when the patient has been fully, with complete transparency on the part of the physician, informed of all possible outcomes, including damage, increased pain, problematic recovery, etc.

    graham yates Reply:

    The problem with your end comment is that this is where it all goes wrong.By suggesting that a persistent pain can be cut away flies against all the evidence.Also there is a risk (14-20% if my memory is correct) of adverse consequences of surgery.
    Unless it can be proven to work beyond placebo,surgery should not be “on the table”as an option.Saying its a last option is akin to saying we will give something a go and see how it turns out,which is OK if it has no harmful effects which is obviously not the case with surgery.
    Of course you would be fighting against a powerful lobby group,who are performing year on year, more spinal fixations in private practice against the evidence.
    I am not anti doctors,but they have a Hippocratic responsibility to their patients which I feel they are not addressing.

  7. PS: the pain management / intervionalist health industry should give thanks and homage to the placebo effect. Where would they be without it?

  8. Thanks for this excellent and frank article.
    Question/s (after a bit of a preamble):
    Surgery outcome success in pain and pain related disability is measured in the research largely by patient reported outcomes and comparisons to other treatments. These are referenced confidently as validated justification by proponents even when more objective measures such as analgesia use and functional capacity are contradictory (eg: spinal surgery). These were the measures by which eg: arthroscopy surgery was measured prior to sham comparisons, with positive measures even accompanied by reduced analgesia use and better function. Both of these measures are logically, and now essentially proven to be, subject to powerful and real placebo construct effects in pain and pain related disability. Yet they are still applied as ‘valid’ to all surgeries in this field that have not been subjected to sham comparisons (and even those that have).
    Do we, as a scientific community, need to have a serious rethink about these ‘validated’ measuring methods trotted out as ‘best evidence’ to justify potentially harmful and likely directly ineffective procedures? Shouldn’t there be a serious push for sham controlled trials for all pain-targeting surgeries (and especially spinal surgeries) so that science can be better equipped to combat ‘belief’?

  9. The problem for treating (persistent) pain is manual and psychological therapies only offer a mild improvement in outcomes.Medication offers help but with many negative side effects.Surgery has a massive placebo effect.
    If we were evidence based we might want to pull the carpet under the whole pain field.
    That would obviously cause distress/ fear leading to more pain.
    Until people are educated in pain and realise they need to look after themselves (sleep,stress,exercise,diet,mood etc) they will need to believe that somebody can help them.
    The best we can do is help them work on these factors and deal with thinking errors along the way.

  10. Hi Louie, I like the idea of powerful rituals for the placebo response that dont rely on a general anaesthetic ! There are many that work that allow the mind control to be relinquished in favour of the natural healing response of the body. From my experience with patients the further it is away from their reality the better. The “holy grail” is the ultimate metaphor.

  11. This is good stuff. So, as I understand it, surgery can and does alter structure and should perhaps be used when necessary for that purpose. However altering structure does not necessarily alter pain. So, really it is the “interactive effect” that leads to convincing the brain of no threat and therefore the pain experience shuts down. So the issue is how does one consistently convince/influence anther persons perception to the point that there is a consistent decrease in pain? Tough to do.

    EG Reply:

    Nicely put. Keep in mind that threat is a function of selfhood. Self is an output of mind (just like pain). To go beyond that, one needs to stop the mind through meditation. This can be done whilst treating the client.

    It is tough to do, I agree. So hard to apply consistently. But when the mind is sufficiently quiet, an unusual kind of certainty arises that the pain is going to reduce or disappear. This certaintly is impossible to conjure in a normal state of consciousness.

  12. I have three unrelated points to make:

    1) An anaesthetic has a powerful amnesic effect. It also completely shuts down the self networks/nodes, without which there can be no threat registered. IV ketamine has been used successfully to treat chronic pain. So the type of anaesthesia (twilight, none, hypnotic, level 1- 4) all need to be considered as potentially active therapeutic agents. Comparing surgery to sham surgery is useful, but greater depth of investigation around the anaesthetic is necessary.

    2) Where is the cut off point? At what point does tissue damage or structural change suddenly become relevant in terms of the necessity for surgery? OA hips get replaced with great regularity and great success [in terms of pain reduction and improved function]. What would sham THR surgery show us? I have a very strong feeling it would be equivalent to the real surgery. I hope someone has the courage to do this one day.

    3) How often have you heard this from a client? – “My surgeon told me I’d need to return in two years to have the other hip replaced… and you know what? He was spot on! Almost two years to the day”. I bet I’m not the only one who’s heard this story.