A Closer Look At The Research Behind MIRE Therapy
- Volume 20 - Issue 7 - July 2007
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Both Leonard and Arnall only compared pre- and post-therapy results within the active or within the sham groups.7,8 There was no analysis that compared outcomes between treatment groups. Since there was such a large placebo effect in the sham treatment group, there is not a significant difference between active and sham therapy at the end of the studies. For instance, in the Leonard study, researchers correctly identified 2.4 out of five SWM sites in the active group and 3.0 out of five sites in the sham group.7
Clifft and colleagues provide the only report that compares outcomes between sham and active treatment groups.9 Clifft did not identify any significant difference between MIRE treatment and sham treatment.
Intent to treat (ITT) is a basic tenet of evaluating data from clinical trials. Essentially, ITT dictates that researchers include every patient who is randomized into a study in the analysis. It stops investigators from eliminating those who did not get a good result, were not compliant or had a negative response for some other reason.
Leonard, et al., did not provide an analysis of the entire study population. They separately reported outcomes and provided analysis for patients with severe neuropathy and less severe neuropathy.7 The group with severe neuropathy did not benefit from MIRE therapy. Leonard’s results primarily focused on patients with less severe neuropathy or patients who could feel the 300 g SWM. Monochromatic infrared light energy did not have any benefit among people with severe neuropathy. This seems like a very odd way to dichotomize the study population. There is a very wide range among patients who can feel between 10 and 300 g of force.
Questioning The Use Of The SWM
The main tool used to evaluate changes in sensory neuropathy in all three randomized, controlled trials was some form of the SWM. While many papers tout the SWM as good screening tool for neuropathy with loss of protective sensation, the inaccuracy and inconsistency of SWMs and changes in the instrument’s loading force over time make it a poor choice for clinical research.5-9
Yong, Booth and McGill described inaccuracy and variability of new SWM and changes in the loading force of instruments with repetitive use.10-12 The “pivotal” studies to evaluate MIRE therapy have relied on a flawed and usually inaccurate tool to test neuropathy.
Vibration perception threshold (VPT) testing is a test that is recommended for use in longitudinal studies. Arnall’s paper was the only one that used VPT testing as part of the clinical evaluation of sensory neuropathy. Although no data was cited, there was not a significant change in VPT, according to Arnall.
Leonard reported “statistically significant” improvement in sensory neuropathy in limbs that received MIRE therapy.7 However, even if the statistical analysis the researchers used in the study was correct, the statistically significant results do not seem like they are clinically meaningful.
For instance, at the end of Leonard’s study, in the MIRE treatment group, researchers accurately identified an average 2.4 sites out of five sites tested with the SWM.7 Clinically, “loss of protective sensation” is often defined as one or two sites missed with the 10 g monofilament.10
Accordingly, the level of improvement still leaves the patient with “loss of protective sensation.” The authors did not report the proportion of patients who changed from having a “high-risk foot” to having a normal level of sensation. That type of information would be more meaningful to most clinicians. Arnall, on the other hand, reports that patients in both treatment arms had an improvement in peripheral sensation so the average SWM values were <10 g of force.8
Could MIRE have a systemic effect? All three randomized clinical trials randomized limbs as opposed to randomizing patients. This design could allow for a systemic effect so both extremities could have benefited from therapy which was provided to one limb. This might explain the large and unexpected placebo effect that occurred in all three clinical studies.