Why I’m not fazed by unremarkable results in therapy trials

Remember the old ‘pareto principle’? 80% of the results come from 20% of the input, or as Wikipedia informs me, “the principle of factor sparsity”

I think we’ve got there with musculoskeletal pain, especially low back pain.

The other ‘law’ that might apply is that of diminishing returns.

We’ve learned a great deal about low back pain over my clinical career. We’ve essentially learned what not do to. In the name of progress, thousands of people have put their pain (their bodies) on the line. And progress has not exactly been great right? We’ve learned that paracetamol (acetaminophen) does diddly squat for acute low back pain, and this doesn’t change as pain hangs around (Williams, et al., 2014). We’ve also found out that doing surgery for most back pain isn’t a great thing (except for radicular pain where surgery is better for leg pain than back pain itself) (Chou et al., 2009). We’ve found out that all forms of exercise are great – loads and loads of studies showing this – BUT effect sizes (in other words, how effective it is) are small to modest for both pain and disability. And the most recent study of cognitive functional therapy, while absolutely wonderful and pragmatic and all, is not much different from what has been advocated for at least 30 years while I’ve been in practice (Kent et al., 2023).

Now before Defenders of the Faith accuse me of complete nihilism when it comes to therapy for back pain, let’s do some deconstruction. CFT is an approach where well-trained physiotherapists learn how to carry out guided discovery and graded movements to help people with low back pain explore and gradually expand their movement repertoire. The training is a good 90 hours, apparently, and therapists say they come out of it with greater confidence to: listen, ask open-ended questions, probe for concerns, generate helpful interpretations, then begin to help the person test out movements they may have been less than enthusiastic to do for quite some time. The excellent things about this approach, and the research O’Sullivan and colleagues have done, is that they’ve replicated the ‘method’ (guided discovery, graded movement, really good listening) in different countries, with different researchers, different therapists (though mainly physiotherapists), and in people with different durations of pain.

The outcomes are pretty good. I like that participants were monitored for 52 weeks, so there’s hope the gains they made are durable. I like that they measured patient-specific function rather than ‘standardised’ outcomes. I like that psychosocial factors such as pain self-efficacy, and pain catastrophising and fear-avoidance beliefs were monitored and all show pleasing changes over time.

BUT let’s temper the enthusiasm with some realism, OK? And please, I’m agnostic about what is being done, I care about people. Here’s the thing – pain reduced by around 2 on a 0 – 10 NRS to a mean of 4/10; people felt they could do more by about 15 points on the RMDQ; pain catastrophising reduced by 4 points on the PCS. In other words, although these are statistically significant and better than ‘usual care’ (whatever that means), people with low back pain continue to have ongoing pain at 4/10 on this (stupid) numeric rating scale.

Cutting to the chase, good therapeutic relationship (the ingredients of which are built on empathic and reflective listening, collaboration, warmth, trustworthiness, a sense of competence – see Kinney et al., 2020 for a systematic review of therapeutic alliance in physiotherapists), and therapist confidence when helping someone do a hard thing is critical. Combine this with gentle graded movements to nudge into those areas of mistrust in the body and you have a winning combination. And guess what? It has been core within pain management programmes following a cognitive behavioural approach for most of my 30 years in practice.

The thing is, being confident when you know you are asking people to do the very things that are hard for them to do is not something we learn easily. Most clinicians don’t like seeing people distressed, tearful, angry, frustrated or scared. In a climate where pain has been seen as ‘the enemy’ and eliminating or reducing pain has been the focus, therapists have been just as worried about pain as the people they hope to help.

What do these small reductions in pain intensity and disability despite decades of research tell me?
I have a kind of optimistic view of it all. If the ‘what’ we do (ie movement forms) isn’t super crucial, but the ‘how’ we do it is, then shouldn’t we focus a whole lot more on two important legs of the infamous evidence-based healthcare triad? That is, if movement is a good thing, then that’s our ‘evidence from research’. The other two legs are – clinician’s experience and skills, and the person’s own values and preferences.

If we agree that movement is a good thing, and avoiding is not, then the form of movement a person does isn’t nearly as important as the clinician being able to convey that they are listening and care about the person and that they are safe.

And finally, the person can decide what kind of movement practice suits them! Finally we get to the person in the person-centred care model!

As a person who does not like boring, I demand variety in my movement repertoire. I want to be able to explore movements that interest me, that are demanding but not just focus on my body – I’m happy to push hard to do things that intrigue me, like climbing up a hill to take photographs from the tops, or to dance a complex set to music that sets my heart on fire, or to paddle serenely along the length of a lake with the still water like glass. I want to relish the strength of my body as I lift bags of compost and fertiliser and I rake leaves and dig weeds and prune my damned wisteria yet again.

Because, you see, humans don’t mind doing hard things if it’s worth it, and with the support of a caring person who shows that they’ll be there, waving the flag, as they go for it. And really, that’s what I hold onto when it comes to movement and pain. Be the trustworthy clinician. Be humble about the results. Don’t oversell and hype what isn’t terribly technical but IS hard to do.

If all we learn from the RESTORE trial is that when therapists get confident to listen well, and guide discovery in movement, people begin their own journey to wellbeing, then I’m perfectly happy. Let’s just not trademark this practice. It should be fundamental to practice.

ps for the avoidance of doubt, I’m NOT suggesting that CFT is being ‘trademarked’ – I’m warning against anyone who is thinking of branding or trademarking these strategies (it’s happened before with ways to use good communication in musculoskeletal pain).

Chou, Roger; Baisden, James; Carragee, Eugene J.; Resnick, Daniel K. ; Shaffer, William O.; Loeser, John D. . Surgery for Low Back Pain: A Review of the Evidence for an American Pain Society Clinical Practice Guideline. Spine 34(10):p 1094-1109, May 1, 2009. | DOI: 10.1097/BRS.0b013e3181a105fc

Kent, P., Haines, T., O’Sullivan, P., Smith, A., Campbell, A., Schutze, R., Attwell, S., Caneiro, J. P., Laird, R., O’Sullivan, K., McGregor, A., Hartvigsen, J., Lee, D. A., Vickery, A., Hancock, M., & team, R. t. (2023). Cognitive functional therapy with or without movement sensor biofeedback versus usual care for chronic, disabling low back pain (RESTORE): a randomised, controlled, three-arm, parallel group, phase 3, clinical trial. Lancet. https://doi.org/10.1016/S0140-6736(23)00441-5

Kinney, M., Seider, J., Beaty, A. F., Coughlin, K., Dyal, M., & Clewley, D. (2020). The impact of therapeutic alliance in physical therapy for chronic musculoskeletal pain: A systematic review of the literature. Physiother Theory Pract, 36(8), 886-898. https://doi.org/10.1080/09593985.2018.1516015

Williams CM, Maher CG, Latimer J, et al. Efficacy of paracetamol for acute low-back pain: a double-blind, randomised controlled trial. Lancet 2014; 384: 1586–1596.