Effect of Pain Reprocessing Therapy vs Placebo and Usual Care for Patients With Chronic Back Pain an RCT, 2021, Asher, Gordon et al

JohnTheJack

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https://jamanetwork.com/journals/jamapsychiatry/fullarticle/2784694


Key Points

Question Can a psychological treatment based on the reappraisal of primary chronic back pain as due to nondangerous central nervous system processes provide substantial and durable pain relief?

Findings In this randomized clinical trial, 33 of 50 participants (66%) randomized to 4 weeks of pain reprocessing therapy were pain-free or nearly pain-free at posttreatment, compared with 10 of 51 participants (20%) randomized to placebo and 5 of 50 participants (10%) randomized to usual care, with gains largely maintained through 1-year follow-up. Treatment effects on pain were mediated by reduced beliefs that pain indicates tissue damage, and longitudinal functional magnetic resonance imaging showed reduced prefrontal responses to evoked back pain and increased resting prefrontal-somatosensory connectivity in patients randomized to treatment relative to patients randomized to placebo or usual care.

Meaning Psychological treatment focused on changing beliefs about the causes and threat value of primary chronic back pain may provide substantial and durable pain relief.
 
Treatment effects on pain were mediated by reduced beliefs that pain indicates tissue damage

There always seems to be an assumption in papers spouting this belief, that tissue damage will always be found if it is there to be found. But this belief of the authors simply isn't true. Many, many people will have tissue damage that nobody looked for, or it was looked for by someone incompetent, or it was looked for using the wrong kind of scan or test, or it was looked for in the wrong place, or the science simply isn't developed enough to find the damage. And, of course, once tissue damage has been dismissed as a possibility it is almost impossible to get anyone to look for it again.
 
Pain is pain it matters not one iota what you think causes it it destroys your quality of life the ability to sleep for a reasonable period of time and regardless of the cause will wear you down . so this so called research/opinion of people who have not had to live with a chronic pain condition is worthless waste of time and money . the people who fund this really should wake up to the consequences of ignoring the harm done by denying the lived experience of a very significant number of people .
 
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Columns are: Pain Reprocessing Trmt: Placebo: Treatment as usual

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So, on average, the people with the brainwashing treatment were drinking more alcohol at the end of the treatment, while people in the other two arms were drinking less. They were using more opioid pills while the people in the other two arms were either not using much both before and after, or were using less after. On average, people in the brainwashing treatment were using way more cannabis both before and after treatment than the people in the other two arms.

Surely, if there was such a stunning reduction in pain, we would expect to see people using less cannabis than the people receiving treatment as usual by the end of the treatment? Surely the use of opioids would decrease, rather than increase?

It is interesting that the old 'asking people certain questions is too burdonsome' excuse is wheeled out:
Note. These measures were not collected at follow-up timepoints to reduce burden on study participants.

The protocol suggested that people were going to have an app to record opioid use:
Additionally, the application will ask participants to enter their current medications. We are interested in medications most specifically because of the current opioid crisis, and the potential of the mind-body treatments under investigation here to reduce opioid use. The application has an interface that makes it easy for participants to choose their medications from a dropdown list and to choose their dosage from commonly prescribed options.
 
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protocol said:
Participants randomized to treatment will be scheduled for treatment. Approximately one month after the baseline assessment session, all participants will return for a second assessment. After
this second, post-treatment assessment, participants who were on the waitlist in the placebo study will be offered the option of receiving the open-label placebo treatment. Participants who were on the waitlist in the psychotherapy study will be offered a chronic pain self-help book (Unlearning your Pain, written by Howard Schubiner) and free access to an online chronic pain self-help program based on the psychotherapy treatment (total market value: ~$125). Receiving the treatment will be optional for waitlisted participants.

And then there's the old 'obfuscate the followup measurements, by allowing the wait list participants to do the other treatments' trick. Here, half of the 'treatment as usual' patients were allowed to have the open-label saline injection placebo after the one month treatment period had ended. The other half of the 'treatment as usual' patients were given a self-help book and access to an online self-help program. So, the follow-up data is uninterpretable.

What we are left with then, are results straight after treatment, with the treatment consisting of 8x 50 minute sessions in 4 weeks telling people that their pain is a faulty alarm signal, and they will be better if they ignore it. So, success on the treatment will involve reporting less pain. And here's a questionnaire for you to fill out....
 
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This research is being funded by the Study of the Therapeutic Encounter Foundation, the Radiological Society of North America, and by the Psychophysiologic Disorders Society.

The Study of the Therapeutic Encounter Foundation has a website that someone forgot to finish. Here's the 'about' tab:
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The Psychophysiologic Disorders Society is even more intriguing.

This is what they say about this study:
Thanks to many of our donors, we were able to support a groundbreaking study on the efficacy of Pain Reprocessing Therapy (PRT), one of our mindbody treatment approaches, for patients with chronic back pain.

PPDA Co-Founders Howard Schubiner MD and Alan Gordon LCSW along with Yoni Ashar PhD, Christie Uipi LCSW, Tor Wager PhD and others led the randomized controlled trial at the University of Colorado Boulder. The study used fMRI (functional magnetic resonance imaging) to see the participants’ brains before and after PRT. The results were amazing!

The 'amazing' result of the trial apparently drew the attention of UnitedHealth Group, who has asked these people to consult on model pain clinics:

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And UnitedHealth Group, providing rich pickings for the conspiracy theorists among us, is, according to Wikipedia, an extremely large healthcare and insurance company.
Wikipedia said:
UnitedHealth Group Incorporated is an American multinational managed healthcare and insurance company based in Minnetonka, Minnesota. It offers health care products and insurance services. UnitedHealth Group is the world's eighth largest company by revenue and second-largest healthcare company behind CVS Health by revenue, and the largest insurance company by net premiums. UnitedHealthcare revenues comprise 80% of the Group's overall revenue.[3]

The company is ranked 8th on the 2021 Fortune Global 500.[4] UnitedHealth Group has a market capitalization of $400.7 billion as of March 31, 2021.[

It all adds up to the researchers who ran this study not having a state of equipoise.
 
Recruitment
Patients will be recruited in four ways: 1) referral from pain management providers, 2) advertisement via flyers, electronic bulletin boards, local listservs relevant to chronic pain (i.e., chronic pain patient groups listervs), local newspapers, and social media sites such as Facebook (described further below), 3) direct contact: patients who contact our research group inquiring about chronic pain research will be informed about the present study, 4) advertising through Google (described further below).

We attach to this protocol seven recruitment materials: a flyer, an online posting, a newspaper ad, a Facebook ad, a pamphlet for providers to give interested patients, the Google advertisement,and a screen capture of a study webpage providing an overview of the study and a link to the pre-screening document. Recruitment materials will describe the treatment as a “novel mind-body treatment”.

So participants had already self-selected to believe that mind-body treatments could be useful.
 
Eligible patients will also be asked to complete a task asking them what feelings they currently have and where they feel them in their body (if felt in the body). Recent research has revealed that many feelings have reliable spatial locations in the body (Nummenmaa, Glerean, Hari, & Hietanen, 2013). Since chronic pain patients have altered emotional functioning (Lumley et al., 2011), we hypothesize that they may also have altered bodily correlates of emotions or altered ability to locate emotion in their body. This “body mapping” task will be completed using a smartphone application, which provides an ideal interface for locating feelings in the body (see Figure 2 below). Participants click an “I feel” button to display a list of feelings (i.e., happiness, sadness, pain, fear, stress, etc.), and then can drag a feeling bubble to a bodily location (or to a location indicating “not felt in the body”), and then rate the intensity of the feeling on a visual analog scale.

The beliefs these researchers hold are really rather bizarre.
 
Only had time to briefly skim this but so much is odd.

One (1) telemedicine meeting with physician and then straight to psychology. Where on earth would that be allowed in any medical system? That is shocking. Really shocking. No physical exam. Wow.

In contrast: The set up in NHS for lower back pain in NW England where I work looks like this:

Patient sees their GP and the vast majority of pts will be managed with conservative treatment (anti inflammatories, perhaps some opioids), physical check to rule out red flags/nasty causes and encouragement to keep gently active. Many patients will recover nicely, others will develop more long term chronic LBP. We have no idea why this is the case.

If pain / situation escalates, then GP or self referral to local physiotherapy / musculoskeletal team. Pt generally seen by senior physio and/or advanced MSK practitioner (AMP) - who can refer directly to rheumatology, surgery, neurology, chronic pain and so forth. AMP will complete thorough physical assessment, refer for scans, if needed, and review and discussion about what support available and what the pt wants - because guess what, there are no magic cures for chronic LBP. And we have no idea why some people develop chronic LBP and others with low back pain recover. It is unknown.

If pain is chronic (and oftentimes people manage for decades by 'getting on with it' before it becomes impossible or they reach crisis point) they may wish further support and be referred in chronic pain team (this is v small section of MSK/physio services) and then it is about support, knowledge especially re medications, management (pacing and remaining v gently active without flaring up their pain) and so forth. Because there is no cure. Chronic pain management does what it says on the tin. There is no assumption or expectation of reduction in pain or cure. It is about helping the most distressed, debilitated patients to lead the best quality of life they can with the least distress. This is done with physios trained in chronic pain, pain consultants and pharmacists, and psychologists (where needed and appropriate).

So, how does this link to the paper - well did they actually reduce the pain? Or did the patients feel that they ought to be nice to the therapists and fill in the forms accordingly? Hutan has pointed out that opioid use was increased in the so-called pain-free/low-pain group. If cured (or thereabouts), then why would anyone be taking an opioid. They have horrible side effects especially long term. Not something you'd do unless you felt the necessity. There doesn't appear to have been much discussion about meds in this research which is shocking. Many people with pain will continue taking meds, with horrible side effects, often for a long time.

The whole context of this work is upside down and backwards. They aim for, assume and hope for cure when probably, at best, in some roundabout way they might have helped pts to understand their pain (a bit) and report it bothers them less. That's confusing feeling better with being better. Exactly what PACE tried to do.

As for statements like: "Since chronic pain patients have altered emotional functioning (Lumley et al., 2011)" Words fail me. No, some people in pain understandably have a tough time trying to get their heads around it (it is a massive unwanted and unexpected visitor after all), funnily enough it can be really upsetting to have to adapt to the often shitty changed life circumstances (and cope with social ambiguity situations when patients do not recover fully) and general grimness of 24/7 pain, which probably interferes with work, sleep, concentration, memory, relationships, exercise, social life, sex and so on. It's kinda like the researchers just can't or won't get into thinking how grim it can be. It as if 'pain' is some other thing that other people feel but not us.

Where have they shown that patient's beliefs about their pain where changed? All assumption and nothing objective or real. No check on validity. In essence: Some questionnaires where completed after a wholly woo, unsafe intervention (no physical exam) and the researchers concluded these changes were meaningful or relevant to the patients. No space to hear what the patients thought of this.
 
That's confusing feeling better with being better. Exactly what PACE tried to do.
It is much worse than that. They are confusing reporting feeling better with feeling better, and hence with being better.

Getting people to change what they say is not in itself a meaningful benefit. At least, not to the patient. Might benefit the clinician's and researcher's career.

As for statements like: "Since chronic pain patients have altered emotional functioning (Lumley et al., 2011)" Words fail me. No, some people in pain understandably have a tough time trying to get their heads around it (it is a massive unwanted and unexpected visitor after all), funnily enough it can be really upsetting to have to adapt to the often shitty changed life circumstances (and cope with social ambiguity situations when patients do not recover fully) and general grimness of 24/7 pain, which probably interferes with work, sleep, concentration, memory, relationships, exercise, social life, sex and so on. It's kinda like the researchers just can't or won't get into thinking how grim it can be. It as if 'pain' is some other thing that other people feel but not us.
Medicine really hasn't wrapped its head around the sheer scale of the problem, has it.

Wessely once infamously said about doctors with ME that just because somebody has experienced it does not necessarily grant them more insight into it and the science of it. Which is true. But also true is that just because somebody has not experienced it does not necessarily grant them a more objective and neutral view of it. Direct experience counts, and we all bring our prejudices and wishful thinking to inquiry.
 
One (1) telemedicine meeting with physician and then straight to psychology. Where on earth would that be allowed in any medical system? That is shocking. Really shocking. No physical exam. Wow.

If the pain had been investigated before and no cause had been found for it I think, in the UK, the NICE guidelines for "primary" chronic pain would get used, and they were written by sadists from the UK. So in answer to your question Where on earth would that be allowed in any medical system? The answer is - in the UK.

https://www.nice.org.uk/guidance/ng193

If pain has been declared (by some sadist somewhere in the medical system) to be "primary" or not real, and the patient is assumed to be a drug-seeker, then no treatment is supposed to be offered other than anti-depressants, acupuncture, psychology, exercise and CBT is supposed to be all that's offered. Certainly, no further examination to find the cause of the pain will be offered, as far as I can tell.

https://www.nice.org.uk/guidance/ng193/chapter/Recommendations#managing-chronic-primary-pain
 
The beliefs these researchers hold are really rather bizarre.
Honestly this is basically phrenology except somehow far dumber. This is beyond bizarre considering it's meant to be used in clinical practice, usually with people who don't have a choice. Even for a cult this would be bizarre stuff, or, you know, typical of a cult. So yeah basically a cult.
 
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where is this? In the supplementary material?
 
Does anyone understand whether the fMRI findings mean anything, or what they mean if they do mean something?

I doubt anybody does much.
The prefrontal region is where higher thoughts and thoughts about self tend to be.

So reduced activity in prefrontal region might indicate not thinking such complicated thoughts about how the pain was for oneself. Or it might indicate less in the way of thought about taking part in an fMRI study or less in the way of thoughts about whether the money on parking the car is running out.

There seems to me to be a huge problem with fMRI comparing patients with controls in that there is no way we would expect patients and controls to have similar thoughts while having an fMRI scan - for a hundred and one reasons.
 
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