6 questions you must ask – Determining if clinical treatments are running ahead of the science
As a clinician researcher I am often amazed at the latest trend for treating complex and difficult to manage conditions like tendinopathy. Many patients have been ‘sold’ these treatments as cures, and they buy in with high expectations. As we know there are often poor outcomes and the promised returns do not eventuate or the improvement is minimal.
I use the following six questions to help me answer the question and inform the patient of the likelihood that a treatment might help.
Is the underlying premise that the treatment is based on defensible?
This is where the treatment does not match what is understood about the pathoaetiology or capacity of the tissue to repair. Treatments that suggest you can regain normal tendon structure when the pathology is degenerative fit this, degenerative tendon structure stays degenerative and you cannot regain normal structure. See Sean Dockings study about treating the doughnut not the hole (link).
Is justification for offering the treatment being based on solely pre-clinical evidence using animal models?
Always good to show that a mouse can recover with the treatment, however in overuse tendon injury there are no good small animal models, so healing in a mouse will not be reflected in humans. Horses are a great overuse model, but tendinopathy occurs in these animals at a very young age, again not the most common tendon presentation we see.
Are there adequate clinical data supporting the treatment?
Often case studies, case series or non-randomised studies. None of these study designs will answer the questions about the efficacy of the treatment, if they are placebo controlled then some treatment is usually better than nothing, and most do to account for the natural history of the condition (that may be positive). Many of the interventions require a rest period after the treatment, tendons feel better if you rest them, therefore improvement may not be related to the intervention, more about unloading the tendon. What is worse is the continued use of an intervention when there are clear good quality studies that show no benefit over placebo or usual treatment. There is now sufficient evidence to show that platelet rich plasma is not an effective treatment for tendinopathy.
It is economically unreasonable or are there competing interests for those using the treatment?
Some of these interventions cost thousands of dollars, some require multiple treatments (each costing money). Patients are often looking for a quick fix and are willing to pay, but are distressed when the outcomes do not match the promises. If the clinician is making substantial profit from offering such treatments when they have full knowledge that the evidence is lacking then we must be especially wary. Those who have an interest in a company promoting a treatment should have to declare their conflict to each and every patient.
Has a valid clinical reasoning process for its use been established?
This is a hallmark sign of a funky treatment. If the response to tendon pain is a single treatment regardless of any clinical findings in the history or examination then it is likely that there is no reasoning behind its potential benefits and harms for the person seeking the treatment. How can one treatment be effective for an Achilles tendon in a young sprinter and an older person walking for recreation?
Do the risks outweigh the possible benefits?
All injection therapies and those involving tendon biopsies come with a risk. This is reasonable if the treatment has a chance of benefiting the patient. If the outcomes are poor, then the risks have to be more than the treatment is worth.
So ask yourself as a clinician and then ask the patients if they are willing to ignore the limitations of these interventions before suggesting them as a treatment.