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

Jaybee00 said:
His response here. Doesn’t respond to cannabis. Also note that the scale (metric) for opioid use is number of pills, not mg.
There are many types of opioid pills differing in their potency and mg.
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dave30th said:
7g of cannabis is a lot.
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After treatment, the brainwashing group did have a slight reduction in reported cannabis use, but they were still using twice the amount used by the saline injection placebo group, and 4 times the amount used by the control group.

And yes, re the opioids, we know the scale is number of pills (which I agree is not ideal), and it's not clear if that is daily, or weekly. I'm assuming it's weekly, as otherwise the reported consumption of alcohol (8 to 14 drinks) is pretty remarkable.

The brainwashing group was more likely to be in full time employment prior to the treatment, so they had a better chance of reducing work hours in order to reduce pain. Unfortunately, there is no report of hours worked by the end of the month or at followup.

ETA: To be fair, the participants were asked not to alter any existing treatments during the course of the study. But the protocol suggests that a big potential benefit of the studied treatment is reducing opioid use. The study design with confounded followup and no question asking about opioid use at followup means that the study gives us no objective information about changes in opioid use (or other painkillers). Perhaps most of the participants weren't using opioids much anyway.
 
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The problem with fMRI is that it often doesn't answer a question so much as ask a whole bunch of new ones. There are usually too many factors involved and too many possible explanations.

It is a very interesting tech, but we do not always use it in a way that helps clarify the situation.
 
Daisybell said:
I think @Woolie might be the person to answer this!
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Localizer analyses identified 16 regions within the mask of interest positively associated with evoked pain intensity, including bilateral insula, cingulate, bilateral somatotopic back areas S1 and secondary somatosensory cortex, and prefrontal regions... Relative to placebo, PRT reduced pain-related activity in aMCC (t133.48 = −1.73; P = .04) and the anterior prefrontal cortex (aPFC; t133.48 = −1.85; P = .03). Relative to usual care, PRT reduced pain-related activity in the left anterior insula (aIns; t120.1 = −2.34; P = .01).
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Its not very meaningful @Daisybell. They started with 16 regions of interest - that is, they went in with 16 chances of finding some sort of difference between their treatment and control groups on fMRI. That's a lot of second chances. They would have needed to correct for multiple comparisons, and I can't see anywhere where they've done this. The the p values they reported are large and none would survive even a gentle correction.

Even if the differences were reliable, it would still be almost impossible to interpret what they mean about mental functioning. Regions like the anterior midcingulate cortex and the anterior PFC have been associated with a lot of different tasks and situations, and we still don't fully understand what exact roles these regions play in supporting our overall cognitive function. There's a lot of hot disagreement in the literature. So, we're nowhere near the position of being able to say "Oh, yes, that reduced activation there in region X means that the person is doing Y". It just doesn't work like that.

You can't work backwards like that, you need to start by committing yourself to one or two carefully chosen predictions, and then see if they pan out. One reasonable prediction you could make is that this pain reprocessing therapy might lead to better top-down control over pain, so we should expect to see greater anterior PFC activity in response to evoked pain than in the control group (that's what a lot of placebo pain studies claim to have found), These researchers found the opposite. But they seem to think that whatever way the data goes, it somehow supports their conclusions - heads we win, tails you lose Obviously, that's just cheating :thumbsdown:
 
Joan Crawford said:
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
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i am surprised you are surprised.

This is what is happening here for ME. And in fact for Long-COVID clinic, which seemingly exist ‘to reassure the patient’- they are then streamlined into self-management and education programs.

The chronic pain program is also based on BPS, minimizing contacts with the drs and maximizing on BPS and self-management.

All the programs mentioned mention you have to be committed in your own recovery. (IE Acceptance and Commitment therapy)
 
Hutan said:
After treatment, the brainwashing group did have a slight reduction in reported cannabis use, but they were still using twice the amount used by the saline injection placebo group, and 4 times the amount used by the control group.

And yes, re the opioids, we know the scale is number of pills (which I agree is not ideal), and it's not clear if that is daily, or weekly. I'm assuming it's weekly, as otherwise the reported consumption of alcohol (8 to 14 drinks) is pretty remarkable.

The brainwashing group was more likely to be in full time employment prior to the treatment, so they had a better chance of reducing work hours in order to reduce pain. Unfortunately, there is no report of hours worked by the end of the month or at followup.

ETA: To be fair, the participants were asked not to alter any existing treatments during the course of the study. But the protocol suggests that a big potential benefit of the studied treatment is reducing opioid use. The study design with confounded followup and no question asking about opioid use at followup means that the study gives us no objective information about changes in opioid use (or other painkillers). Perhaps most of the participants weren't using opioids much anyway.
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That the differences were present at baseline, rather than emerged with treatment, seem important here.

Also, I know it's meant in a jokey way, but talking about the brainwashing group could be an unhelpful habit for discussing research like this, especially if people are also reaching out to researchers on twitter.
 
Also, I know it's meant in a jokey way, but talking about the brainwashing group could be an unhelpful habit for discussing research like this, especially if people are also reaching out to researchers on twitter.
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Absolutely not meant in a jokey way, quite the opposite. The therapy is called 'Pain Reprocessing Therapy'. The abstract says that it is a
'psychological treatment focused on changing beliefs about the causes and threat value of primary chronic back pain'.

Brainwashing, also called Coercive Persuasion, is a systematic effort to persuade nonbelievers to accept a certain allegiance, command, or doctrine. A colloquial term, it is more generally applied to any technique designed to manipulate human thought or action against the desire, will, or knowledge of the individual.
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Hutan said:
Absolutely not meant in a jokey way, quite the opposite. The therapy is called 'Pain Reprocessing Therapy'. The abstract says that it is a
'psychological treatment focused on changing beliefs about the causes and threat value of primary chronic back pain'.
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'Brainwashing' also comes from cold war paranoia and it seems questionable that the original understanding of 'brainwashing' is something that is even possible. If it is, it seems it would need more extreme measures than occur within the NHS. There's also a history of people using 'brainwashed' to dismiss those who have been persuaded of things that the accuser dislikes.

Changing people's beliefs isn't necessarily brainwashing - we've all tried to change other peoples' beliefs, and had our own beliefs changed by others. There's a spectrum between reasoned persuasion and dishonest manipulation. If we have a culture where patients concerned about some of the specifics around CBT (or any therapy that intends to change patient beliefs) casually refer to that as brainwashing then I expect that's more likely to create confusion than be helpful.
 
I've been reading about the main author of the study and his clinic in Los Angeles, that is Alan Gordon, LCSW. and his Pain Psychology Center.

Gordon is associated with Dr. Harold Schubiner (mind-body medicine) who believes that stress explains exactly everything and who is also an author of the chronic back pain study referenced above.

My conclusion is that the study was essentially a marketing ploy.

The power of suggestion, using psychotherapy and relaxation to lower the subjective experience of pain is all well and good. But not to blow this out of proportion and make it into a cult. Again, this is the USA and anything can be made into a $$brand$$. Looks like we'll be needing David Tuller soon on the homefront.

PS I would love to get rid of my fibromyalgia by talking pretty to my brain, were it that simple-minded.
 
Found this thread again. I posted about a brain training websites that is now selling their services. Thread here: https://www.s4me.info/threads/brain-retraining-online-programs.24102/

in which way can the authors claim that injecting sterile water subcutaneously represents a placebo treatment?

Typically, if your treatment of choice is psychology based, wouldn’t the placebo control be a sham psych ie: sitting in a group and say Hom for an hour?

I was trained to give sterile water injections in the back as a registered nurse (we got an inservice and practiced on each other, we never put it in practice for our patient population) and when i played the patient for a nurse to practice, i could not complete the 4 injection sites, it was so painful. i would not qualify that as placebo to the brain washing treatment.
 
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OK, so I can believe that in some cases carefully pushing through back pain can be beneficial - I've done it myself. Some back problems benefit from gently using your back, even though it can hurt and is uncomfortable, and a bit scary; it has helped me get over some issues.

But - what has that got to do with Long Covid?
 
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Andy said:
Completely unsurprisingly, Paul Garner has today tweeted a link to this study
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I am surprised that Paul Garner would draw attention to this poor study of 'pain reprocessing therapy'. If I was one of the select group of people that Paul Garner allows to reply to his nonsense, I would say:

1. It is interesting that Paul Garner chose to praise this particular study, as it has many of the flaws that are commonly seen in psychosomatic and alternative therapies research. NICE recently rated the outcomes of research with these flaws as being of low or very low quality.

2. Paul Garner says that "changing beliefs cured chronic back pain". By the end of the intervention, use of alcohol and opioids had increased in the group with the 'changing beliefs' treatment. They were still using, on average, over 4 times the amount of cannabis that the people in the control treatment cohort were using.

3. The researchers fervently believed in the 'changing beliefs' treatment. There was no state of equipoise.

4. The research was funded by the 'Study of the Therapeutic Encounter Foundation', which has a website that appears to have been hastily created and is not finished. The 'About Me' section says 'I am a paragraph. Click here to add your own text'. The research was also funded by the Psychophysiologic Disorders Society. Authors of the study went on to become consultants to United Health Group, a very large health care and health insurance company that has a substantial financial interest in reducing claims by people with chronic back pain.

5. Trial participants were recruited in a way that made it much more likely that they were favourably disposed to the idea that changing their beliefs would reduce their pain.

6. There were no reliable objective outcomes. It is a fundamental flaw in experimental design when unblinded treatments are combined with only subjective outcomes. There is a huge body of evidence showing that multiple biases combine to make the findings of such flawed studies worthless in assessing treatment effectiveness. This is particularly true when combined with participants who believe the treatment will work, and with researchers who are incentivised to find that the treatment works. It is even more true when the treatment involves learning to deny having pain and the outcome is the answer to the question 'so, how much pain do you have?'.

7. The people in the 'changing beliefs' group were more likely to be in full time employment prior to the treatment than the people in the other two treatment arms, so they had a better chance of reducing work hours in order to reduce pain. There is no report of hours worked by the end of the treatment, or at followup.

8. The study claims that gains were largely maintained at followup. However, the protocol suggested that participants in the control treatments would be given access to instruction in 'unlearning their pain'. Therefore, the followup results are actually largely uninterpretable.

8. The protocol suggested that participants would use an app to record opioid use for collection at follow-up timepoints because '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'. In an echo of the PACE researchers abandoning activity monitors supposedly because they were too burdensome for the trial participants, this study reported regarding measures of the use of alcohol, opioids and cannabis that 'these measures were not collected at follow-up timepoints to reduce the burden on patients'.

9. Multiple interpretations can be applied to fMRI data and, with a large number of variables, the analysis is particularly susceptible to cherry-picking and researcher bias.

10. Even if it really was true that chronic back pain can be cured by changing beliefs, that does not mean that other health conditions would respond in the same way.

11. It is particularly concerning that Paul Garner, who works in medical evidence analysis and has a role in Cochrane, seems to think that this study was useful. The problem created by the combination of unblinded treatments, a lack of objective outcomes and researcher bias is one that even students of experimental design should be able to identify.

I see that Ben Marsh and Michelle Bull have tweeted in reply to Paul Garner's tweet, @PhysiosforME. Perhaps they or others can use the points above and/or flag the discussion here.
 
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Hutan said:
6. There were no reliable objective outcomes. It is a fundamental flaw in experimental design when unblinded treatments are combined with only subjective outcomes. There is a huge body of evidence showing that multiple biases combine to make the findings of such flawed studies worthless in assessing treatment effectiveness. This is particularly true when combined with participants who believe the treatment will work, and with researchers who are incentivised to find that the treatment works. It is even more true when the treatment involves learning to deny having pain and the outcome is the answer to the question 'so, how much pain do you have?'.
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The actual differences on the scales between the groups were actually quite small, around 1 point on a 1-10 point scale, for example. This is very consistent with a difference in questionnaire answering behaviour, rather than underlying health. (combined with a regression to the mean/natural recovery across all groups)

Hutan said:
9. Multiple interpretations can be applied to fMRI data and, with a large number of variables, the analysis is particularly susceptible to cherry-picking and researcher bias.
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Most of the fMRI findings were not consistent - they'd have to be found for both the treatment-as-usual and 'open label placebo' groups for it to be valid.
 
Just stumbled (again) across the Psychophysiologic Disorders Association (PPDA) and how they use their[*] study discussed here as "proof" to promote their hypothesis and treatment recommendations for a "mindbody approach" -- and are proud that the 'UnitedHealth' Group seem to be interested in their expertise.

Now saw that it was already discussed here:

Hutan said:
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 thought I'll add the text of the screenshot and leave some links here, both to forum threads and other links.

Text from the screenshot posted by Hutan:

Changing the healthcare paradigm

"UnitedHealth Group, the world’s largest healthcare company, asked PPDA Co-Founder Dr. Howard Schubiner to consult on model pain clinics with a team of physicians, physician’s assistants, nurse practitioners, physical therapists and mental health providers, all trained in mindbody medicine. Christie Uipi led the behavioral health team.

"It’s incredibly exciting and challenging to put our ideas into a real-world clinic, and this wouldn’t have happened without the support of PPDA donors who helped us to sponsor the clinical trial (above).

https://ppdassociation.org/about

More links:

"The Boulder Back Pain Study - Proof that a psychological approach can cure chronic pain"

https://mytmsjourney.com/resources/...psychological-approach-can-cure-chronic-pain/


....and in the UK:

They are also supporters of the SIRPA conference (SIRPA = "Stress Illness Recovery Practitioners’ Association, the first group in the UK & Europe to adopt the TMS approach to chronic pain") :

https://www.sirpaconference.com/supporters/

SIRPA website:
https://www.sirpa.org/


More about Schubiner who's both on PPDA's board of directors and acts as SIRPA's research adviser:

fossil said:
There's a new film on the way about treating pain with mind-body medicine, (NOT a recommendation);

"THIS MIGHT HURT is a feature-length documentary that explores the chronic pain epidemic by following a group of patients as they attempt a last-resort treatment called mind-body medicine."

http://www.thismighthurtfilm.com/#intro

fossil said:
[...]I'm not sure if there is any mention of ME/CFS in the film, but the focus of the film is the work of Howard Schubiner, who thinks CFS is a Psychophysiologic Disorder (PPD.) He is a cofounder of the Psychophysiologic Disorders Association. CFS is mentioned on this page;

https://www.ppdassociation.org/patient/
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There is a thread about Schubiner's thoughts on CFS here;

https://www.s4me.info/threads/2016-...essful-situations-from-past.6786/#post-123135

From his Psychology Today article mentioned in the above thread;

"You might be amused by the idea that an underlying personality style would have anything to do with chronic fatigue and pain."


From the PPD Association's site;

"With our focus on uncovering sources of stress, trauma and unrecognized emotion, patients are able to relieve and even CURE their symptoms without surgery, physical therapy, medication, or expensive alternative treatments."

https://www.ppdassociation.org/about/


More about their activities, including a fibromyalgia study and another film, Pain Brain, also coming out this year;

https://www.ppdassociation.org/impact
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[*] From PPDA's website:

"Thanks to many of our donors in 2017, we were able to sponsor the first randomized controlled trial showing that chronic back pain can not only be managed, but can be CURED using a mindbody approach. And the study was published in JAMA Psychiatry, one of the top medical journals!

"PPDA Co-Founders Alan Gordon and Dr. Howard Schubiner along with Dr. Yoni Ashar, Christie Uipi and Dr. Tor Wager led the study at the University of Colorado Boulder."


Edited to remove confusing link to related topic but different persons and organizations.
 
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Oh. And the the PPDA's president and co-founder David Clarke is medical advisor of the UK enterpise "Living Proof", founded in 2022 by someone who describes herself as recovered from ME/CFS after "she learned about the mindbody approach from a Buddhist nun, and started to understand that her symptoms were directly related to recent significant stresses [...]"

"[Penny George] made a rapid recovery, left the job and has worked ever since to help others understand there is hope of recovery."

Living Proof's mission is ...

"To promote widespread understanding and application of the mindbody approach to health among practitioners, patients, and the general public".

https://www.livingproof.org.uk/our-team

Surprisingly, 'Living Proof' also refers to the Boulder back pain study, claiming:

"What is new, however, are emerging studies which show that we can actually reverse chronic pain and other misunderstood symptoms through applying techniques which calm the nervous system, and help us process our repressed emotions.

"For example, two studies were published in September 2021 that both independently demonstrated that a mindbody approach is a highly effective treatment for chronic back pain. "
 
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