Comparison of a Single-Session Pain Management Skills Intervention With a Single-Session Health Education Intervention and 8..., 2021, Darnal et al

rvallee

Senior Member (Voting Rights)
Full title: Comparison of a Single-Session Pain Management Skills Intervention With a Single-Session Health Education Intervention and 8 Sessions of Cognitive Behavioral Therapy in Adults With Chronic Low Back Pain, A Randomized Clinical Trial


Question
Is a single-session pain relief class noninferior to 8 sessions of cognitive behavioral therapy (CBT) at 3 months after treatment?

Findings In this 3-arm randomized clinical trial that included 263 adults with chronic low back pain, a single-session pain management skills class was noninferior to 8 weeks of CBT and superior to a health education class for pain catastrophizing and multiple secondary outcomes at 3 months after treatment.

Meaning For patients with chronic low back pain, a single-session pain relief skills class showed comparable efficacy to CBT in pain catastrophizing, pain intensity, and pain interference and other outcomes at 3 months after treatment.


https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2783047
 
Will probably get lost in the storm of NICE's caving, but this appears to be the PACE trial of CBT for lower back pain.

It tests what it calls "Empowered relief" (trademarked, of course), which seems to be a commercial product a bit similar to LP, though with less cultist vibes. A single session here shows "reductions" across the board on several psychosocial and symptomatic self-ratings, from fatigue to pain, however the primary outcome was "pain catastrophizing".

The benefits shown on pain, a secondary outcome here, appear relatively low and subject to several biases. Of course impossible to tell whether the changes are 1) artificial, 2) related to perception or 3) related to reporting.

What this is shows is that 1-hour "course", which "teaches skills" (gamification appears to be a big thing nowadays, you are upgrading!) is better than several sessions of face-to-face CBT at either of changing reporting, perception, or just fudging the results by manipulating the participants.

I was alerted to this trial by a glowing near informercial-level of promotion by Stanford Medicine (and oh wow Stanford itself is developing it and appears to be using it as an income source: https://empoweredrelief.stanford.edu/): https://scopeblog.stanford.edu/2021...relieves-chronic-low-back-pain/?sf149080985=1. It shows a similar process to what is happening with Mahana and their CBT for IBS app, including creating a significant business empire out of it:

Now, Darnall's team is expanding access to the Empowered Relief program to help address existing disparities in pain care. The class is already available in five languages and seven countries to treat chronic pain -- and the team has certified 300 healthcare clinicians around the world as Empowered Relief instructors.​

Given that this falls in line with the other identical trials of its type, this is likely of interest to you, @dave30th.
 
$10.3M awarded for this junk study. This is scandalous. There have been dozens, if not hundreds, of those trials already. Adding another BS pseudoscientific comparison changes nothing at all, it's exactly equivalent to swapping homeopathic treatment, water vs. water. I don't even know how it could be possible to spend over $10M on this, it's 100% online, is very low effort. I don't even know how to spend $1M on this, it's deliberately inflating the cost to create a sunk cost, exactly like with PACE.

And to have the nerve to pretend that this is what patients want. This is explicitly abusing patient involvement for their own purpose, there is exactly zero chance that an open discussion lead to this.



And this has exactly zero to do with that, a complete sham of fake patient engagement:



This is not serious, it's not something that needs to be understood, it's a setup with a manufactured outcome, you don't spend $10M pushing something for it to fail:



Again, $10M for this, how? Spent on what?!

 
I'm not so sure this is as bad as you suggest, @rvallee. The initial study at the top of this thread showed that their 2 hour 'pain empowerment' session was just as effective as 8 sessions of CBT. And the patient can do the 2 hour session at home and anonymously with no interaction. It sounds like it's giving information about accessing medical treatment, and things people find helpful in self managing pain etc.
If that's shown to be the case in a bigger study, then it pretty much kills off CBT as the first line treatment for pain, since it's no better than watching a single video.
The two treatments may both be just getting patients to fill in questionnaires differently and not having a real effect, but at least the 2 hour session doesn't give access to CBT therapists to mess with people's heads and heap blame on them for not coping. And if the single session is as effective on questionnaires, with far less 'therapist effect' skewing the results, then it may actually be a bit useful.
 
It's sold as a "mind-body intervention" and the tagline is literally "Train your brain away from pain", but OK. Woo for everyone, then! Frankly pretty much appears to be the same stuff as LP, it's also a commercial product hidden behind a paywall. As explained in the first paper:
Empowered relief consists of a single-session, 2-hour pain class that includes pain neuroscience education, mindfulness principles, and CBT skills (identifying distressing thoughts and emotions, cognitive reframing, a relaxation response exercise, and a self-soothing action plan).
So something that includes CBT is... noninferior to CBT. And of course:
The primary efficacy outcome for noninferiority and superiority analyses was Pain Catastrophizing Scale score at 3 months after treatment
Useless as an outcome. It's the same formula, with the same intent. So, no, it may not actually be a bit useful, because we all know how this ends and that the sole intent is cost-saving. Even has the same assumptions as PACE:
A key feature of the Empowered Relief class is the empowerment of self-awareness of what may be called negative or unhelpful thoughts through the use of well-known pain catastrophizing scale
 
If that's shown to be the case in a bigger study, then it pretty much kills off CBT as the first line treatment for pain, since it's no better than watching a single video.

My partner's response to your comment was "so everyone's a winner; patients now only suffer through 2 hours of B***S*** instead of 16 and Darnell et al. make loads of money on Zoom calls!"
 
This whole system works by showing patients that they are being fobbed of by their doctors and in order not to waste their doctors time or their own time . they may as well forget the medical profession exists as an option for them .
 
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