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In reading the study by Govind and colleagues,1 in which they report the findings of an unblinded, uncontrolled, non-randomised trial of radiofrequency neurotomy for the treatment of third occipital headache, we are surprised that the authors advocate this therapy.
The last statement of the abstract is: “No other form of treatment has been validated for this common form of headache”. This implies that Govind et al believe they have validated radiofrequency neurotomy as a form of treatment of third occipital headache. Presumably they are prepared, given the apparently impressive numbers of responders, to forego the usual practice of placebo controlled trial.
We do not understand how the authors can expect this treatment to be realistically adopted in clinical practice with no attempt to validate it the way treatments are meant to be validated, through randomised, placebo controlled trials. The statement in their final paragraph that “some practitioners may be averse to implementing a treatment that requires repetition” could perhaps more appropriately state that “some practitioners may be averse to implementing a treatment that remains unvalidated”.
The authors state that one reason they did not do a placebo controlled study is that a previous study has already validated this technique in other patients.2 That a single trial of radiofrequency neurotomy in 24 so-called “whiplash patients” is sufficient basis for the current authors to abandon validation with traditional methods seems absurd, especially when closer inspection of that trial lays it in a less positive light.3 We do not accept an argument that it was impossible to blind these subjects. It would be entirely reasonable to see just how often a placebo procedure does indeed “fool” the patient. Govind et al seem to have already decided that this is not possible, a convenient assumption.
Further, we are concerned that Govind et al state categorically that “among patients with whiplash injuries, third occipital headache is common”. The study group from which they determine this prevalence has been reviewed elsewhere, and is wholly inappropriate for a prevalence estimate, being best described as an unusual, highly select, and heterogeneous group of subjects.3
It is of note that, in regard to validated therapies for whiplash patients, the current study would have been rejected by the criteria of the Quebec Task Force on Whiplash Associated Disorders.4 We suggest that an invasive procedure should not be advocated until it has been subjected to proper study. Fortunately, we are aware that others are undertaking a properly controlled trial of this form of therapy.
Our study reported an audit of outcomes for a treatment of a condition for which there is no other treatment available. It showed what proportion of patients obtained complete relief of pain, and for how long. Readers who wish to adopt this treatment for their patients can do so. If not, they should explain to their patients that they, personally, cannot offer them any treatment that is known to work; but they should not claim that there is no treatment. Our study shows that there is an option.
A placebo controlled trial would not prove that this treatment does not work. The outcomes should be the same as the benchmark established by our study, unless the operators perform the procedure poorly. A placebo controlled study could only show that all or part of the outcome is attributable to non-specific effects.
We consider this to be an unlikely outcome for we have never encountered in any of our own studies, nor in the literature, results showing that 86% of patients obtain complete relief of spinal pain following a sham procedure. Radiofrequency neurotomy has been shown to be associated with placebo responses in only a small proportion of patients, and for a limited duration.1 They claim that responses to third occipital neurotomy is only a conjecture. In principle it is worthy of testing, but in practice it cannot be tested.
The precepts of informed consent require that participants in a randomised controlled be informed of all the consequences and potential complications of a procedure. Numbness in the territory of the third occipital is an unavoidable side effect of third occipital neurotomy. It is a sign that the target nerve has been coagulated. It is an essential requirement for the procedure to work. The numbness lasts as long as the pain relief lasts. In a double blind trial this side effect cannot be masked. Therefore, patients who underwent a sham procedure would automatically know that they did not have the real treatment. Thereby the patients would be unblinded. Any placebo controlled trial which suffered unblinding would be fatally flawed and, therefore, unacceptable.
Any study that used a control short of a sham procedure would also be flawed, and would not escape criticism. Pundits would argue that patients would recognise that simply blocking the nerve, or simply inserting the electrode without mimicking the two hour procedure assiduously, is an obvious sham, and that any patient so treated would exhibit a nocebo effect.
For these reasons we did not venture to conduct a placebo controlled trial. If Dr Kwan and Dr Friel can show that a sham procedure on the third occipital nerve succeeds in achieving complete relief of pain in 86% of their patients we will gladly convert to their sham procedure.
We recognise it as a pity that our study would not be accepted by systematic reviews; but that is a problem for those who rely on reviews as the only source of evidence. In that regard we stand in good company. Were we to rely only on systematic reviews, radiofrequency neurotomy for trigeminal neuralgia would not be an accepted treatment; nor would we be allowed to perform appendicectomies.
While others are satisfied to deny care to patients while they engage in purist debates about levels of evidence, we are rewarded with patients grateful for the relief that they obtain, and who report: “you must repeat the procedure because I am never going back to suffering headaches again”. If someone devises a better treatment for third occipital headache, we will adopt it. In the meantime we feel it would be dishonest of us to tell our patients there is nothing we can do for you.