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My deep understanding of how clinical trials work has really helped me. In those weeks when my hip is twinging I'm reminded to stick to my personal treatment plan.
As a result I can do more with less hip pain.
That understanding, together with my personal experience, now underpins my treatment philosophy. And by taking a closer look at the data here I hope to help all 160 to also do more with less pain.
So let’s take a deeper dive into that first BMJ paper...
Remember that one-line conclusion of a ‘significant benefit of exercise over no exercise in patients with osteoarthritis’.
A one-liner that sounds a bit abrupt. It doesn’t come close to doing justice to the months of hard work by many, many researchers across multiple studies.
It may be a simple one-line, BUT it is very carefully considered.
The results of 60 clinical trials fed into that one line. One big analysis that sits on top of a lot of well-done published research and hard work.
So how do trials work?
I volunteered for one of the first COVID-19 vaccine trials in 2020. A randomised control trial, or RCT.
That trial proved that the vaccine worked keeping people more healthy, either free from COVID-19 or free from severe disease.
Swap COVID-19 for joint osteoarthritis [THE PROBLEM]
Swap vaccine for activity [THE TREATMENT] and
Swap free of COVID-19 for less pain and better function [THE OUTCOME]
...and we have ONE of the SIXTY clinical trials included in that BMJ paper.
An RCT gets to the heart of ‘does this treatment work or not?’ So, say I have hip osteoarthritis and sign up...
The ‘R’ of RCT randomly assigns me to one of two groups, on the equivalent of a coin toss.
The ‘C’ RCT is the ‘control’ group. So, I might be assigned to the treatment or be given the equivalent of a sugar pill. The 'sugar pill' is the control group.
In the COVID-19 vaccine trial that was another known vaccine against meningitis, nothing to do with COVID-19.
In trials looking at activity, the control group was given advice, without specific guidance on exercise or activity. As part of the control group, I may well exercise off my own bat, but I'm not given any specific regime.
You might then join the trial and be assigned to either group. Perhaps joining the treatment group and given a regime with advice on how and when to exercise.
Hang on… but isn’t that a bit unfair? Some people get treated, some not...
Well, no. Not if we truly do not know the answer. And in this case at the start of these trials we did not whether exercise worked or not.
Taking part in a clinical trial is extremely valuable, especially when answering an important question like this.
And especially when the answer might go on to help all subsequent people who get [THE PROBLEM] way into the future.
Seen in this context, there’s an argument for more, if not all, people and patients to be offered entry into a clinical trial relevant to their particular treatment.
Once underway, you, me and the other participants go about their everyday lives following the protocol of treatment (exercise) or control (no specific exercise).
Pain and function are measured using some kind of scale, score or question set.
And the change in pain and function score between the start and end of the trial is measured for you, me, and every other participant in the trial.
Those changes in pain and function are totted up for each group and compared.
Well proven statistical tests determine if any difference between the groups is real or occurred by chance.
That's it for one Randomised Controlled Trial.
Now add in the results of 59 other well done trials. What do we get?
For strengthening exercise (compared to control): a decrease in pain of 2.03 cm on a 10 cm visual analogue scale.
It might not sound it, but THAT is a really important difference.
Important How?
Well, ‘8,218 patients’ is a relatively big number in clinical research. But like any big study, or combined study, this result only looks at a sample of people. And that sample contains a spread of results.
So, like most research, the paper adds a range around that 2.03cm improvement to define how confident we can be in the result.
In this paper that range of improvement is between 2.8 cm and 1.3 cm. There's therefore a 95% chance that the real life improvement in pain actually lies somewhere between 2.8 cm and 1.3 cm.
By real life I mean for all people who exercise their osteoarthritic hip or knee out in the real world. Everyone. You, me, everyone reading this, and everyone yet to get the message.
Now the bigger the sample gets the closer we get to the real life answer for everyone.
And to state the obvious, if you sample everyone in the world with osteoarthritis, you'll get the true real life answer for everyone in the world.
The sample size and spread of results therefore give us an idea of how confident we can be in the overall result.
And importantly, the 95% confidence interval here did NOT INCLUDE ZERO.
(which would mean there's no benefit)
Confidence in this result is high, and the authors define the effect size as ‘large’.
That is... Movement Works.
And a final point…
In the paper, the maximum length of follow-up- the time between the first and final set of questions- ranged from a fairly short 4 weeks to a modest 79 weeks.
The mid-point time interval for all of the studies was only 15 weeks. A little under four months. Not a particularly long time to see the true benefit of exercise.
Especially when people suffer with hip and knee osteoarthritis year on year for many years.
The good news is we can keep dosing exercise month on month, year on year for many years.
So, that VAS score improvement of 2 out of 10cm shows the real-world improvement in pain and function that everyone with joint osteoarthritis can expect.
We can be confident in the benefit of activity.
And we can keep dosing activity over and over each and every day.
So, if activity was a drug, the newspaper headlines would shout ‘MIRACLE CURE’!!
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