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In this letter the authors observe "a significant difference ..in the rate of offspring malformations between women who dive (6 children affected), and those who did not dive during their pregnancy (none had malformation, p<0.01). A rate of zero malformations in the non-diving population should immediately have alerted the authors to the fact that their survey was biased. In the UK population there is an approximate rate of malformation of 1 in 80 live births and I would think that the rate is similar in France. Instead of using 0 for the malformations the authors should have used the rate observed in the French population. The conclusion of the paper that pregnancy testing should be undertaken before each scuba diving session is not supported by these data.
The last paragraph cites Rolfing when it should be Structural Integration. There are many schools of Structural Integration of which Rolfing Structural Integration is one, Describe the modality as massage if you must, though I would prefer, "a form of manual therapy" or "a form of manual therapy that is often categorized as massage." I am surprised that this error passed through the editors and peer review.
The Ankle Roll Guard (anklerollguard.com) is a patented & independently tested, brace-less ankle support that cushions the ankle from an inversion or “roll”. Unlike conventional ankle braces, it wraps securely around the outside of any shoe type and allows the user to retain full ankle mobility and comfort.
Benefits:
- Patented outside shoe design allows user to retain ankle mobility & comfort while still having ankle protection (no ankle restriction like a brace)
- Provides ankle stability & protection for users with chronic lateral ankle instability
- Clinical, independent testing at Boise State University using a motion analysis system showed equivalent inversion protection plus better range of motion & vertical jump versus a brace or tape
- Weighs only 2.4 ounces so users do not feel it
Independent Testing at Boise State University
White Paper Completed January, 2018:
“Of all the devices (Ankle Roll Guard, Brace, Tape), only the Ankle Roll Guard appears to allow the user normal ankle motion (i.e. typical anatomical joint motion), while preventing excessive ankle inversion”
– Tyler Brown, PhD, CSCS, Director COBR
Conclusion: The Ankle Roll Guard may provide similar prevention of excessive inversion as either the brace or tape, but without the mechanical restriction of the joint that reportedly limits physical performance when wearing ankle prophylactic devices. With the Ankle Roll Guard, p...
The Ankle Roll Guard (anklerollguard.com) is a patented & independently tested, brace-less ankle support that cushions the ankle from an inversion or “roll”. Unlike conventional ankle braces, it wraps securely around the outside of any shoe type and allows the user to retain full ankle mobility and comfort.
Benefits:
- Patented outside shoe design allows user to retain ankle mobility & comfort while still having ankle protection (no ankle restriction like a brace)
- Provides ankle stability & protection for users with chronic lateral ankle instability
- Clinical, independent testing at Boise State University using a motion analysis system showed equivalent inversion protection plus better range of motion & vertical jump versus a brace or tape
- Weighs only 2.4 ounces so users do not feel it
Independent Testing at Boise State University
White Paper Completed January, 2018:
“Of all the devices (Ankle Roll Guard, Brace, Tape), only the Ankle Roll Guard appears to allow the user normal ankle motion (i.e. typical anatomical joint motion), while preventing excessive ankle inversion”
– Tyler Brown, PhD, CSCS, Director COBR
Conclusion: The Ankle Roll Guard may provide similar prevention of excessive inversion as either the brace or tape, but without the mechanical restriction of the joint that reportedly limits physical performance when wearing ankle prophylactic devices. With the Ankle Roll Guard, participants exhibited more natural ankle motions (i.e. plantar flexion) during both the sudden inversion event and vertical jump. This motion allowed the participants to perform better during the vertical jump with the Ankle Roll Guard as compared to the more restrictive brace and tape.
I congratulate the authors for such a well-rounded and informative update of this CPG. I was not surprised to see the conclusion in the text that the evidence is 'unclear' in the use of ice on acute ankle injuries. There simply are not enough well-controlled RCTs can support RICE's efficacy when used alone. Clinically, we always combine ice with other interventions such as exercise. Your recommendation in the text was, "There is no evidence that RICE alone, or cryotherapy, or compression therapy ALONE (emphasis added) has any positive influence on pain, swelling or patient function. Therefore, there is no role for RICE ALONE (emphasis added) in the treatment of acute LAS." Based on the evidence, I would agree with that statement. However, Table 8's "Final Recommendations" for RICE states, "RICE is not advised as treatment modality after a LAS." I would argue that the authors should have inserted the word, "ALONE" in this recommendation; otherwise, they are making a blanket conclusion that ice is NOT effective when in fact, the evidence remains unclear (there may be some benefit when used in conjunction with other treatments) and potential harmful effects were not discussed if that was part of the decision-making. Unfortunately, I was unable to find the meta-analysis data upon which these recommendations against RICE were made, as Supplement 3 did not include any analysis on RICE interventions. While I am not a...
I congratulate the authors for such a well-rounded and informative update of this CPG. I was not surprised to see the conclusion in the text that the evidence is 'unclear' in the use of ice on acute ankle injuries. There simply are not enough well-controlled RCTs can support RICE's efficacy when used alone. Clinically, we always combine ice with other interventions such as exercise. Your recommendation in the text was, "There is no evidence that RICE alone, or cryotherapy, or compression therapy ALONE (emphasis added) has any positive influence on pain, swelling or patient function. Therefore, there is no role for RICE ALONE (emphasis added) in the treatment of acute LAS." Based on the evidence, I would agree with that statement. However, Table 8's "Final Recommendations" for RICE states, "RICE is not advised as treatment modality after a LAS." I would argue that the authors should have inserted the word, "ALONE" in this recommendation; otherwise, they are making a blanket conclusion that ice is NOT effective when in fact, the evidence remains unclear (there may be some benefit when used in conjunction with other treatments) and potential harmful effects were not discussed if that was part of the decision-making. Unfortunately, I was unable to find the meta-analysis data upon which these recommendations against RICE were made, as Supplement 3 did not include any analysis on RICE interventions. While I am not a proponent of quick and repeated prescription of NSAIDS, I was disappointed to see the statement concluded that NSAIDS may "delay the natural healing process," based on a review commentary published 15 years ago in a non-peer reviewed journal, rather than basing this comment on at least one well-controlled study with evidence that NSAIDS do, in fact, delay the healing process (which I have never seen). Furthermore, when I examined the meta-analysis data on oral NSAIDS on Swelling (3 studies), I noticed that 2 out of 3 favored the placebo, and none of the studies had a significant difference as their confidence intervals all included zero. Only grouping oral with topical NSAIDS provided a favorable effect size. You can't have it both ways when it comes to making statements based on the literature by holding the evidence to different standards to support such statements.
This is a case of exertional heat stroke in which a young, experienced woman runner exerts herself and develops heat stroke. There is no effort to describe the patient's state of hydration besides indicating that she drank 250 mL prior to running (in what timeframe?) and that she drank 200mL after/during collapse. We are unaware of her weight and thus cannot even roughly calculate what her fluid deficit range may be after 90 minutes of running. We are unaware of her dress, which could lead to heat retention. Per figure 2, it appears that her blood pressure was approximately 110/70 at the time of collapse, which does not support hypovolemia. Values of BUN and creatinine are not presented that would have supported dehydration as a predisposing condition. Certainly in a road race there were other runners that reached her same level of hydration - why did they not suffer heat stroke?
While this is a classically presented case of exertional heat stroke in a road race, there is insufficient evidence to associate it with dehydration.
I was quite surprised to see this piece in a BMJ journal. It is quite odd and doesn't appear to bear much relationship to the data. If any readers are interested I strongly suggest that the read the original peer reviewed lancet PACE trial paper and make up their own minds. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)60096-2/abstract
Zorrzi et al. (1) have recently compared the sensitivity and specificity of the European Society of Cardiology (2010) and the International (2017) ECG criteria for the diagnosis of hypertrophic cardiomyopathy (HCM), concluding that the International criteria have a greater specificity and a slightly lesser sensitivity in making a differential diagnosis from the normal hypertrophy of an endurance athlete's heart.
However, such an analysis presupposes a clear identification of normal from pathological cases, and this appears to be lacking. The sole criterion for the diagnosis of HCM is "the presence of a hypertrophied and non-dilated left ventricle in the absence of other diseases that could produce the same magnitude of hypertrophy," based on an echocardiographic wall thickness equal to or greater than 15 mm in adult index patients and equal or greater to 13 mm in adult relatives.
Given the exclusion of patients with symptoms or evidence with systolic dysfunction, there seems little to exclude the possibility that the individuals identified are not simply exceptionally well-trained endurance athletes, and that what is being examined is simply the ability of the 2 sets of ECG criteria to identify a person who has developed a large heart. It is particularly disturbing that the supposed diagnostic criteria seems to make no allowance for age, body size and sex, all of which undoubtedly influence the range of normal cardiac dimensions.
Zorrzi et al. (1) have recently compared the sensitivity and specificity of the European Society of Cardiology (2010) and the International (2017) ECG criteria for the diagnosis of hypertrophic cardiomyopathy (HCM), concluding that the International criteria have a greater specificity and a slightly lesser sensitivity in making a differential diagnosis from the normal hypertrophy of an endurance athlete's heart.
However, such an analysis presupposes a clear identification of normal from pathological cases, and this appears to be lacking. The sole criterion for the diagnosis of HCM is "the presence of a hypertrophied and non-dilated left ventricle in the absence of other diseases that could produce the same magnitude of hypertrophy," based on an echocardiographic wall thickness equal to or greater than 15 mm in adult index patients and equal or greater to 13 mm in adult relatives.
Given the exclusion of patients with symptoms or evidence with systolic dysfunction, there seems little to exclude the possibility that the individuals identified are not simply exceptionally well-trained endurance athletes, and that what is being examined is simply the ability of the 2 sets of ECG criteria to identify a person who has developed a large heart. It is particularly disturbing that the supposed diagnostic criteria seems to make no allowance for age, body size and sex, all of which undoubtedly influence the range of normal cardiac dimensions.
REFERENCE
Zorzi A, Calore C, do Vio, R et al. Accuracy of the ECG for differential diagnosis between hypertrophic cardiomyopathy and athlete's heart: comparison between the European Society of Cardiology (2010) and International (2017) criteria. Br J Sports Med 2018; 52: 667-673.
We want to thank Boynton et al. for writing a letter to the editor (LTE) in response to our recent editorial on gender disparities in the sport and exercise medicine (SEM) community [1]. As the title of our editorial indicates [We need to talk about manels: the problem of implicit gender bias in sport and exercise medicine], we were primarily motivated to stimulate a conversation about the issues we raised, and an LTE contributes to this conversation [2].
We were also motivated by a desire to assert that i) the SEM community does indeed manifest many examples of gender disparity; ii) social media has provided a space where this issue is being debated, notably (but not exclusively) under the hashtag #manels; iii) implicit bias is a significant contributor to these disparities, and iv) there exist well-established resources where interested readers might explore their own implicit biases [3].
It is in these goals, then, that we fundamentally disagree with most of the assertions the LTE authors have made about our work and the conclusions they draw.
We noted with interest that the authors of the LTE did not take direct issue with our assertion that there exist substantial gender imbalances within the field of SEM. Rather, they took issue with our assertion that implicit gender bias underpins these imbalances.
We posit in our editorial that implicit bias is a factor contributing to the gender disparities we see in SEM. Discussing implicit bias in t...
We want to thank Boynton et al. for writing a letter to the editor (LTE) in response to our recent editorial on gender disparities in the sport and exercise medicine (SEM) community [1]. As the title of our editorial indicates [We need to talk about manels: the problem of implicit gender bias in sport and exercise medicine], we were primarily motivated to stimulate a conversation about the issues we raised, and an LTE contributes to this conversation [2].
We were also motivated by a desire to assert that i) the SEM community does indeed manifest many examples of gender disparity; ii) social media has provided a space where this issue is being debated, notably (but not exclusively) under the hashtag #manels; iii) implicit bias is a significant contributor to these disparities, and iv) there exist well-established resources where interested readers might explore their own implicit biases [3].
It is in these goals, then, that we fundamentally disagree with most of the assertions the LTE authors have made about our work and the conclusions they draw.
We noted with interest that the authors of the LTE did not take direct issue with our assertion that there exist substantial gender imbalances within the field of SEM. Rather, they took issue with our assertion that implicit gender bias underpins these imbalances.
We posit in our editorial that implicit bias is a factor contributing to the gender disparities we see in SEM. Discussing implicit bias in the context of gender inequity in SEM does not mitigate the role of other factors. We do not suggest that implicit bias is the sole driver of gender inequity, but that it is one that warrants attention.
Boynton et al. note, in the references that they cite arguing against implicit bias, that there may be phenomena such as individual choice that may result in such disparities. This may be true. In addition, we would add that at least one other phenomenon we did not mention is explicit bias. Each of the authors on this editorial can note multiple examples where these explicit biases have played out. The issue of ‘manels’ as a manifestation of gender disparities in SEM is merely the tip of the iceberg. Some of the authors of our editorial have written about other gender issues in different media [4]. Society at large, and the SEM community in particular, is still too disturbingly sexist to escape the conclusion that frank, explicit bias is a major driver of the disparities that concern us [5].
In regards to the issue of implicit bias, the body of literature supporting this concept is deep and underpins several of the resources we mention in our editorial. The LTE authors too easily dismiss this work as ‘ideological.’ We counter that, like any scientific theory, implicit bias is a ‘work in progress,’ and that noting a few references arguing against that theory does not tear down the entire body of evidence.
Gender disparities and contributory biases exist at many levels of our field. This is a problem, which could be seen as big or small depending on the observer. It is, nevertheless, a problem. We assert that it must be addressed.
We do agree, at least in part, with our dissenting colleagues, when challenging those of us interested in these issues to seek a ‘higher degree of evidence.’ While there is no lack of evidence for gender disparity in the SEM community, we applaud deeper investigations into these issues and a higher quality of evidence. Furthermore, we advocate for more research into the phenomena that may underpin these disparities.
For those parties interested in gender issues in sport and SEM, we would encourage them to consider looking more deeply into the problems we describe in our editorial and this response. We would like at the very least to see more documentation of gender (mis)representation among keynote speakers at SEM conferences; within academic divisions and departments; within teams (e.g. head team physicians among elite teams), etc. Moreover, analyses of the decision-making processes that lead to these disparities must also be included in future investigations.
Being of service to ourselves and our SEM community means meeting people where they stand. This is a more effective endeavor when we can be transparent about where we are starting from. To that end, we would encourage readers to consider these courses of action while we all continue this conversation:
i) consider taking the implicit bias test we reference [3]
ii) speak up when seeing significant gender disparities at conferences and other fora
iii) Men: mentor the female SEM trainees with which you work, and help them achieve higher levels in their field if they are motivated. And listen thoughtfully to what your female colleagues are saying about these issues
iv) Women: yes, ‘lean in,’ as the saying goes; but also continue to identify systemic biases and try to challenge them
Submitted by Sheree Bekker and James MacDonald, on behalf of all authors of the original editorial:
Sheree Bekker, Osman H Ahmed, Ummukulthoum Bakare, Tracy A Blake, Alison M Brooks, Todd E Davenport, Luciana De Michelis Mendonça, Lauren V Fortington, Michael Himawan, Joanne L Kemp, Karen Litzy, Roland F Loh, James MacDonald, Carly D McKay, Andrea B Mosler, Margo Mountjoy, Ann Pederson, Melanie I Stefan, Emma Stokes, Amy J Vassallo, Jackie L Whittaker
In their International Olympic Committee consensus statement, Maughan et al. reviewed the evidence for dietary supplements for high-performance athletes [1].
They wrote in regard to zinc that “Cochrane review shows benefit of [using] zinc acetate lozenges (75 mg) to decrease duration of URS [upper respiratory symptoms]” [1, Table 4]. This statement was based on their reading of the Cochrane review (2013) by Singh and Das [2], which was withdrawn in 2015 because of plagiarism [3]. In addition, the same Cochrane review had a large number of other severe problems [4]. In the above statement, Maughan et al. imply that only zinc acetate lozenges are effective; however, a recent meta-analysis showed that, up until 2017 at least, there was no evidence that zinc gluconate lozenges are less effective than zinc acetate lozenges [5].
When discussing treatment effects, the size of the effect and its confidence interval should be considered [6]. Thereby a critically-minded reader can form his or her own opinion about whether the treatment effect is relevant. The data of 7 placebo-controlled double-blind RCTs showed that zinc acetate and zinc gluconate lozenges shortened common cold duration on average by 33% (95% CI 21% to 45%) [5]. Individual-patient data were available for 3 zinc acetate lozenge trials and on the basis of these findings, zinc lozenges shortened the duration of colds by 2.7 days (95% CI 1.8 to 3.3 days) [7], and increased the rate of recovery by RR = 3....
In their International Olympic Committee consensus statement, Maughan et al. reviewed the evidence for dietary supplements for high-performance athletes [1].
They wrote in regard to zinc that “Cochrane review shows benefit of [using] zinc acetate lozenges (75 mg) to decrease duration of URS [upper respiratory symptoms]” [1, Table 4]. This statement was based on their reading of the Cochrane review (2013) by Singh and Das [2], which was withdrawn in 2015 because of plagiarism [3]. In addition, the same Cochrane review had a large number of other severe problems [4]. In the above statement, Maughan et al. imply that only zinc acetate lozenges are effective; however, a recent meta-analysis showed that, up until 2017 at least, there was no evidence that zinc gluconate lozenges are less effective than zinc acetate lozenges [5].
When discussing treatment effects, the size of the effect and its confidence interval should be considered [6]. Thereby a critically-minded reader can form his or her own opinion about whether the treatment effect is relevant. The data of 7 placebo-controlled double-blind RCTs showed that zinc acetate and zinc gluconate lozenges shortened common cold duration on average by 33% (95% CI 21% to 45%) [5]. Individual-patient data were available for 3 zinc acetate lozenge trials and on the basis of these findings, zinc lozenges shortened the duration of colds by 2.7 days (95% CI 1.8 to 3.3 days) [7], and increased the rate of recovery by RR = 3.1 (95% CI 2.1 to 4.7) [8]. So far, there is no published evidence to assume that the effects of zinc lozenges are less in athletes compared with the general population.
Maugham et al. wrote that many published studies had low quality, “specifically, small samples, poor controls and unclear procedures for randomization and blinding were commonplace” [1, p. 443]. To support this statement, they cited the above-mentioned Cochrane review [2] that was withdrawn in 2015 [3]. However, that Cochrane review [2] did not point out any relevant methodological problems in the 7 placebo-controlled double-blind zinc lozenge RCTs mentioned above in which colds were shortened by 33% [5].
Furthermore, Maugham et al. did not mention at all the effect of vitamin C on exercise-induced bronchoconstriction [EIB]. Three double-blind placebo-controlled cross-over RCTs found that vitamin C decreased exercise-induced FEV1 decline by 48% (95% CI 33% to 64%) [9,10]. Only some athletes suffer from EIB, yet for them it may be worthwhile to test on an individual basis whether vitamin C has efficacy.
In our Cochrane review, we pooled 5 placebo-controlled double-blind RCTs on marathon runners, skiers and soldiers on subarctic exercises, and found that vitamin C reduced the risk of colds by 52% (95% CI 36% to 65%) [11]. Maugham et al. opined that there is only “moderate support for preventing URS”. Given that the 5 RCTs conducted by 4 different research groups over 3 different decades found highly consistent results with I-square = 0% [11], it is quite puzzling as to what kind of evidence Maugham et al. would require to conclude strong support over and above any moderate support. Evidently, more research is needed. However, vitamin C is a cheap and safe essential nutrient, thus those athletes who often have upper respiratory symptoms associated with exercise may test whether the vitamin might be beneficial for them personally.
Maugham et al. further wrote that for vitamin C, “immune measures [are] no different from placebo” [1, Table 4]. This statement is misleading for readers. A search of the PubMed for reviews on vitamin C and immunity identifies dozens of reports. Reviews have shown that there is a large number of studies indicating that vitamin C does have effects on the immune system, three of which I cite here [12-14]. The published effects on the immune system do not indicate whether vitamin C has practical relevance, but it is misleading to claim that the effects of vitamin C on immune measures are no different from placebo [1].
Finally, Maugham et al. wrote that “Cochrane reviews show no benefit of initiating vitamin C supplementation (>200 mg/day) after onset of URS” and they cited refs 100,101 in their review [1, Table 4]. First, Maugham’s reference 101 is not a Cochrane review. Second, absence of evidence is not evidence of absence [15].
In our Cochrane review (ref. 100 in Maugham’s paper), we wrote that from a methodological perspective, therapeutic trials are much more complicated than regular supplementation trials [11]. We gave examples of factors that may influence the efficacy of vitamin C, such as the timing of supplementation initiation, the duration of supplementation, and the dosage. Inappropriate selection of any of these factors might give rise to false negative findings in a therapeutic trial. We should therefore be cautious in the interpretation of the published therapeutic trials. Furthermore, we pointed out that “The larger effect observed using 8 g [of vitamin C] compared with 4 g as a single dose in the Anderson 1974f trial and the dose dependency in the Karlowski 1975a trial suggest that future therapeutic trials with adults should use doses of at least 8 g/day” [11]; see also [16].
It thus misleads readers to claim that our Cochrane review (ref. 100 in Maugham’s paper) “show[s] no benefit of initiating vitamin C supplementation after [the] onset of URS” [1]. In contrast, we conclude in our abstract that “given the consistent effect of vitamin C on the duration and severity of colds in the regular supplementation studies, and the low cost and safety, it may be worthwhile for common cold patients to test on an individual basis whether therapeutic vitamin C is beneficial for them. Further therapeutic RCTs are warranted” [11].
I would like to raise some comments regarding the paper ‘Foot orthoses for plantar heel pain: a systematic review and meta-analysis.’ Whittaker et al, 2018, Br J Sports Med. 52(6): 322-328, and the editorial ‘Foot orthoses research: identifying limitations to improve translation to clinical knowledge and practice’, Griffiths & Spooner 52(6) in the same edition.
I would like to applaud the intention of the paper by Whittaker et al, to try and establish a conclusion to the question of foot orthoses efficiency in treating heel pain symptoms. This same praise I also give to the editorial in bring into the discussion the potential issue of the validity of random control trials as a research method to test foot orthoses efficiency. However, some key issues with the paper need exploring beyond the issues raised in the editorial in regarding how orthoses may work.
There are several key issues with the paper by Whittaker et al, which overall is a noble attempt to make sense of the present research on using orthoses for plantar heel pain. The issues are; plantar heel pain is a symptom not a diagnosis (therefore some of these studies may include multiple conditions); the studies are subject to potential bias (addresses by the authors); the studies do not compare like with like studies and seemed to have been shoe horned together to achieve a conclusion; and finally, foot orthoses do not logically conform to randomised control trials. Despite the best efforts of th...
I would like to raise some comments regarding the paper ‘Foot orthoses for plantar heel pain: a systematic review and meta-analysis.’ Whittaker et al, 2018, Br J Sports Med. 52(6): 322-328, and the editorial ‘Foot orthoses research: identifying limitations to improve translation to clinical knowledge and practice’, Griffiths & Spooner 52(6) in the same edition.
I would like to applaud the intention of the paper by Whittaker et al, to try and establish a conclusion to the question of foot orthoses efficiency in treating heel pain symptoms. This same praise I also give to the editorial in bring into the discussion the potential issue of the validity of random control trials as a research method to test foot orthoses efficiency. However, some key issues with the paper need exploring beyond the issues raised in the editorial in regarding how orthoses may work.
There are several key issues with the paper by Whittaker et al, which overall is a noble attempt to make sense of the present research on using orthoses for plantar heel pain. The issues are; plantar heel pain is a symptom not a diagnosis (therefore some of these studies may include multiple conditions); the studies are subject to potential bias (addresses by the authors); the studies do not compare like with like studies and seemed to have been shoe horned together to achieve a conclusion; and finally, foot orthoses do not logically conform to randomised control trials. Despite the best efforts of the researchers to correlate the results to present a conclusion, reading the paper only shows that the paper was challenging statistically to produce. The studies so far published on this subject are so full of issues that any attempt to achieve coherence and a conclusion is potentially meaningless no matter how many attempts at statistical manipulation are thrown at the problem.
Despite this statistical need to achieve a result from poor data, the main problem must be that no attempt was given to provide the symptom of plantar heel pain a diagnosis in some of the studies involved in the review. This immediately invalidates the whole premise that these studies be included. We can hardly expect the same treatment to work for plantar fasciopathy, porta pedis nerve entrapment, Baxter’s neuroma or osteoarthritis of the subtalar joint. Each can cause plantar heel pain, but the mechanism of injury is different. Randomly sticking in insoles will give random results, perhaps the only conclusion we can take from these types of papers.
The editorial by Griffiths and Spooner discusses some of the issues in regards foot orthoses research used in random control trials. The authors of the editorial discuss the way the foot and the orthosis must interplay within the fundamentals of the laws of mechanics. These are principles of mechanics not unique to orthoses, but for anything that creates an interface between the foot and the ground. This is why a sham (placebo) orthosis in a study has potentially the same chance of influencing biomechanics as a so-called ‘real orthosis’. The difference in effects between the sham and the orthosis under test will be dependant on the difference between the shape and materials used in the two insole types.
The manufacture technique to produce the orthosis is probably irrelevant (1.2.3.4). Sadly some studies have failed to establish significant difference between insole types, picking a sham that is very close in design and material to the orthoses under test. Others studies pick custom orthoses of a much more robust design compared to the preform comparison orthosis (5.6). Bias is a serious problem in many studies.
The authors of the editorial claim that foot orthoses “can only exert their effect via placebo effect and/or directly modifying ground reaction forces at the foot-orthosis interface”. Kinematic and realignment effects are dismissed as “unlikely”. This statement is difficult to substantiate when compared to a wealth of published-research where much data on kinematic changes are reported (primarily in the foot) with foot orthoses (4.7.8.9.10.11.12). Similar kinematics changes occur when footwear and lack of footwear are compared (13.14).
Different kinematic effects have also been shown with different prescription additions on orthoses (15.16), which indicates how important individual prescription addition is to get a particular desired effect. However, data in regards to foot orthoses producing kinematic changes in sports related studies are less conclusive (17). This is likely to be in part because the contact time for the foot in running is reduced to around 40% (dependant on running pace) resulting in a significant float phase where neither foot is in ground contact. During float phase the orthosis has no mechanical influence except on increasing the foot segment mass in swing. Orthoses cannot redirect forces if there is no ground reaction force to interact with. Other issues such as preferred movement pathways (18) might over ride the effect of the orthosis or shoes especially in studies conducted on healthy asymptomatic runners.
The issue in sport is different to orthopaedics, in that most commonly in sportspeople, issues of mal-alignment and joint dysfunction are usually small. Sports medicine is largely about treating the ‘fit and well’, pushing their tissues to fatigue. In sport poor lower limb function or mal-alignment of a significant nature enough to significantly influence energetics, is rare. Such dysfunction would prevent a patient from being normally active. In orthopaedics serious postural mal-alignments that cause, or are a cause of dysfunction, are commonly found in patient contacts, and here changes with foot orthoses are likely to be more significant.
Griffiths & Spooner’s editorial proposes that the effects of orthoses are most likely to be due to kinetic changes within the tissues. This leads to the suggestion that for research, orthoses must be chosen that equally change the tissue stresses within specific tissues in different individuals, rather than picking the same prescription.
Sadly as we have no way of routinely assessing internal body kinetics within tissues dynamically, this suggested research pathway is not yet readily open to us. If possible, such an approach would also raise complications in that individual variance in morphology and body tissue composition would still make subject selection as well as prescription selection quite challenging. Orthoses requirements to achieve the same outcome could be quite different, unless subjects were match on many physiological and anatomical similarities. This would also make random control trials almost impossible.
There are other ways by which foot orthoses can be implied to change tissue kinetics. Changes in muscle activity in the presence of foot orthoses would imply that tissue kinetics has changed. Such evidence exists if not strongly (19), although evidence exists of rocker shoes altering muscle activity (20.21). As stated before orthoses and shoes work on the same interface.
Foot orthoses may also be able to initiate a neuro-mechanical effect. Something touching the body will create a reaction, possibly just in reaction to avoid the object as occurs when we feel a small stone in our shoe. What ever induces changes in muscle activity is likely to change kinematics, energetics as well as internal and external kinetics.
Again it must be understood that a so-called ‘sham orthosis’ has the potential to alter biomechanics and energetics. This single fact seriously questions whether random control trials using a so-called ‘sham orthosis’ are suitable for testing so called ‘real foot orthosis’ efficiency.
Another consideration is that poor biomechanics is primarily more than just forces being applied to the body in the wrong direction. Joint and muscle dysfunction are intrinsically linked. As a consequence, outside of the research world, foot orthoses are rarely used in isolation. If exercises, mobilisation, manipulation, shoe selection and foot orthoses all produce statistically arguable benefit when studied individually, there might yet be a significant effect when each are combined appropriately together. There is a challenge for research to look at treatment protocols rather than one treatment at a time!
Where the possibility of merely a placebo effect achieved by foot orthoses can firmly be challenged is in papers like Halstead et al (22), which looks at changes in pathology over time with foot orthoses on MRI and is the kind of randomised control trial that is more suitable for foot orthoses. More of these studies on diagnostic image changes produced by foot orthoses are required if we are ever going to learn more specifically which prescription variances are required to reduce stress and therefore strain on specific musculoskeletal tissues and their pathologies. Whether the outcome is good or bad, will still give us a far greater insight into the orthoses ability to change tissue stresses.
The reason good foot orthoses research is limited is more a result of most studies not knowing what effects they wished achieve to resolve particular pathologies. Especially so in studies where symptoms, rather than pathology is chosen. These ‘chosen’ pathologies need to be very specific, for in just the case of Achilles tendinopathy the mechanical causes are multiple, and specific areas within the tendon function differently (23.24.25).
To compare effects of a foot orthosis prescription in a manner similar to a random control trial of a pharmaceutical would need a large scale study performed on subjects of similar mass, strength, tissue age, morphology, and limb segment lengths. Subjects would need to have the same pathology and mechanism of injury with the same level of tissue damage. I would also suggest that treatment orthoses were tested for effects on energetics too to test comparable effects on mechanical efficiency. Any other type of random control study risk being like testing a drug for its effect on abdominal pain, regardless of the cause. Sadly most foot orthoses studies published at present make establishing truth within them extremely difficult and the construction of coherent random control reviews almost impossible.
References:
1. Landorf K, Keenan AM, Herbert R. Effectiveness of foot orthoses to treat plantar fasciitis: a randomized trial. Arch Intern Med. 2006. 166:1305-10. doi: https://doi.org/10.1001/archinte.166.12.1305
2. Davis I, Zifchock R, Deleo A. A comparison of rearfoot motion control and comfort between custom and semicustom foot orthotic devices. J Am Podiatr Med Assoc. 2008. 98(5):394-403. PMID:18820043
3. Redmond A, Landorf K, Keenan AM. Contoured, prefabricated foot orthoses demonstrate comparable mechanical properties to contoured, customised foot orthoses: a plantar pressure study. J Foot Ankle Res 2009. 2:20. doi: https://doi.org/10.1186/1757-1146-2-20
4. Short L, Chockalingam N. Kinematic comparison of functional foot orthoses produced to three different manufacturing protocols: An exploratory study. OA Musculoskeletal Medicine 2015 10;2(2):14.
5. Trotter, L, Pierrynowski, M. The short-term effectiveness of full-contact custom-made foot orthoses and prefabricated shoe insets on lower-extremity musculoskeletal pain. J Am Podiatr Med Assoc. 2008. 98(5): 357-363. PMID:18820037
6. Trotter, L.C., Pierrynowski, M.R. (c). Changes in gait economy between full-contact custom-made foot orthoses and prefabricated inserts in patients with musculoskeletal pain. J Am Podiatr Med Assoc. 2008. 98(6): 429-435. PMID:19017850
7. McPoil TG, Cornwall MW. The effect of foot orthoses on transverse tibial rotation during walking. J Am Podiatr Med Assoc. 2000. 90(1): 2-11. doi: https://doi.org/10.7547/87507315-90-1-2
8. Reed L, Bennett P. Changes in foot function with the use of Root and Blake Orthoses. J Am Podiatr Med Assoc. 2001 91(4):184-193. PMID:11319248
9. Branthwaite HR, Payton CJ, Chockalingam N. The effect of simple insoles on three-dimensional foot motion during normal walking. Clin Biomech. 2004. 19(9):972-977. doi: https://doi.org/10.1016/j.clinbiomech.2004.06.009
10. Eslami M, Begon M, Hinse S, et al. Effect of foot orthoses on magnitude and timing of rearfoot and tibial motions, ground reaction force and knee moments during running. J Scien Med Sport. 2009. 12(6): 679-684. doi: https://doi.org/10.1016/j.jsams.2008.05.001
11. Levinger P, Menz H, Marrow A, et al. Relationship between foot function and medial knee joint loading in people with medial compartment knee osteoarthritis. J Foot Ankle Res. 2013. 6:33 http://www.jfootanleres.com/content/6/1/33
12. Rodrigues P, Chang, R, TenBroek T, et al. Medially posted insoles consistently influence foot pronation in runners with and without anterior knee pain. Gait Posture. 37(4):526-531. https://doi.org/10.1016/j.gaitpost.2012.09.027
13. Divert C, Mornieux G, Baur H, et al. Mechanical comparison of barefoot and shod running. Int J Sports Med 2005. 26(7): 593-598. doi https://doi.org/10.1055/s-2004-821327
14. Eslami M, Begon M, Farahpour, et al. Forefoot-rearfoot coupling patterns and tibial internal rotation during stance phase of barefoot versus shod running. Clin Biomech 2007. 22(1): 74-80. doi: https://doi.org/10.1016/j.clinbiomech.2006.08.002
15. Nakajima K, Kakihana W, Nakagawa T, Mitomi H, et al. Addition of an arch support improves the biomechanical effect of a laterally wedged insole. Gait Posture. 2009. 29(2): 208-213. doi: https://doi.org/10.1016/j.gaitpost.2008.08.007
16. Zhang X, Li B, Hu K, et al. Adding an arch support to a heel lift improves stability and comfort during gait. Gait Posture. 2017 58(1): 94-97. doi: https://doi.org/10.1016/j.gaitpost.2017.07.110
17. Ferber R, Davis IM, Williams DS. Effect of foot orthotics on rearfoot and tibial coupling patterns and variability. J Biomech. 38(3): 477-483.
doi: https://doi.org/10.1016/j.jbiomech.2004.04.019
18. Nigg B, Baltich J, Hoerzer S, et al. Running shoes and running injuries: mythbusting and a proposal for two new paradigms:’preferred movement path’ and ‘comfort filter’. Br J Sports Med. 2015 49(20): 1290-1294. doi: https://doi.org/10.1136/bjsports-2015-095054
19. Murley G, Landorf K, Menz H et al. Effect of foot posture, foot orthoses and footwear on lower limb muscle activity during walking and running: A systematic review. Gait Posture 2009. 29(2): 172-187. doi: https://doi.org/10.1016/j.gaitpost.2008.08.015
20. Stöggl T, Müller E. Magnitude and ariation in muscle activity and kinematics during walking before and after a 10-week adaption period using unstable (MBT) shoes. Footwear Scienc. 2012: 4(2): 131-143.
21. Maffiuletti N. Increased lower limb muscle activity induced by wearing MBT shoes: physiological benefits and potential concerns. Footwear Scienc. 2012: 4(2): 123-129.
22. Halstead J, Chapman G, Gray J et al. Foot orthoses in the treatment of symptomatic midfoot osteoarthritis using clinical and biomechanical outcomes: a randomised feasibility study. Clin Rheumatol. 2016. 35(4): 987-996. doi: https://doi.org/10.1007/s10067-015-2946-6
23. Zifchock, R, Piazza, S. Investigation of the validity of modelling the Achilles tendon as having a single insertion site. Clin Biomech. 2004. 19 (3): 303-307. doi: https://doi.org/10.1016/j.clinbiomech.2003.11.010
24. Lee, S, Piazza, S. Inversion-eversion moment arms of gastrocnemius and tibialis anterior measures in vivo. J Biomech. 2008. 41(16): 3366-3370. doi: https://doi.org/10.1016/j.jbiomech.2008.09.029
25. Franz J, Slane L, Rasske K, et al. Non-uniform in vivo deformations of the human Achilles tendon during walking. Gait Posture. 2015. 41(2):192-197. doi: https://doi.org/10.1016/j.gaitpost.2014.10.001
In this letter the authors observe "a significant difference ..in the rate of offspring malformations between women who dive (6 children affected), and those who did not dive during their pregnancy (none had malformation, p<0.01). A rate of zero malformations in the non-diving population should immediately have alerted the authors to the fact that their survey was biased. In the UK population there is an approximate rate of malformation of 1 in 80 live births and I would think that the rate is similar in France. Instead of using 0 for the malformations the authors should have used the rate observed in the French population. The conclusion of the paper that pregnancy testing should be undertaken before each scuba diving session is not supported by these data.
The last paragraph cites Rolfing when it should be Structural Integration. There are many schools of Structural Integration of which Rolfing Structural Integration is one, Describe the modality as massage if you must, though I would prefer, "a form of manual therapy" or "a form of manual therapy that is often categorized as massage." I am surprised that this error passed through the editors and peer review.
The Ankle Roll Guard (anklerollguard.com) is a patented & independently tested, brace-less ankle support that cushions the ankle from an inversion or “roll”. Unlike conventional ankle braces, it wraps securely around the outside of any shoe type and allows the user to retain full ankle mobility and comfort.
Benefits:
- Patented outside shoe design allows user to retain ankle mobility & comfort while still having ankle protection (no ankle restriction like a brace)
- Provides ankle stability & protection for users with chronic lateral ankle instability
- Clinical, independent testing at Boise State University using a motion analysis system showed equivalent inversion protection plus better range of motion & vertical jump versus a brace or tape
- Weighs only 2.4 ounces so users do not feel it
Independent Testing at Boise State University
Show MoreWhite Paper Completed January, 2018:
“Of all the devices (Ankle Roll Guard, Brace, Tape), only the Ankle Roll Guard appears to allow the user normal ankle motion (i.e. typical anatomical joint motion), while preventing excessive ankle inversion”
– Tyler Brown, PhD, CSCS, Director COBR
Conclusion: The Ankle Roll Guard may provide similar prevention of excessive inversion as either the brace or tape, but without the mechanical restriction of the joint that reportedly limits physical performance when wearing ankle prophylactic devices. With the Ankle Roll Guard, p...
I congratulate the authors for such a well-rounded and informative update of this CPG. I was not surprised to see the conclusion in the text that the evidence is 'unclear' in the use of ice on acute ankle injuries. There simply are not enough well-controlled RCTs can support RICE's efficacy when used alone. Clinically, we always combine ice with other interventions such as exercise. Your recommendation in the text was, "There is no evidence that RICE alone, or cryotherapy, or compression therapy ALONE (emphasis added) has any positive influence on pain, swelling or patient function. Therefore, there is no role for RICE ALONE (emphasis added) in the treatment of acute LAS." Based on the evidence, I would agree with that statement. However, Table 8's "Final Recommendations" for RICE states, "RICE is not advised as treatment modality after a LAS." I would argue that the authors should have inserted the word, "ALONE" in this recommendation; otherwise, they are making a blanket conclusion that ice is NOT effective when in fact, the evidence remains unclear (there may be some benefit when used in conjunction with other treatments) and potential harmful effects were not discussed if that was part of the decision-making. Unfortunately, I was unable to find the meta-analysis data upon which these recommendations against RICE were made, as Supplement 3 did not include any analysis on RICE interventions. While I am not a...
Show MoreThis is a case of exertional heat stroke in which a young, experienced woman runner exerts herself and develops heat stroke. There is no effort to describe the patient's state of hydration besides indicating that she drank 250 mL prior to running (in what timeframe?) and that she drank 200mL after/during collapse. We are unaware of her weight and thus cannot even roughly calculate what her fluid deficit range may be after 90 minutes of running. We are unaware of her dress, which could lead to heat retention. Per figure 2, it appears that her blood pressure was approximately 110/70 at the time of collapse, which does not support hypovolemia. Values of BUN and creatinine are not presented that would have supported dehydration as a predisposing condition. Certainly in a road race there were other runners that reached her same level of hydration - why did they not suffer heat stroke?
While this is a classically presented case of exertional heat stroke in a road race, there is insufficient evidence to associate it with dehydration.
I was quite surprised to see this piece in a BMJ journal. It is quite odd and doesn't appear to bear much relationship to the data. If any readers are interested I strongly suggest that the read the original peer reviewed lancet PACE trial paper and make up their own minds.
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)60096-2/abstract
Zorrzi et al. (1) have recently compared the sensitivity and specificity of the European Society of Cardiology (2010) and the International (2017) ECG criteria for the diagnosis of hypertrophic cardiomyopathy (HCM), concluding that the International criteria have a greater specificity and a slightly lesser sensitivity in making a differential diagnosis from the normal hypertrophy of an endurance athlete's heart.
However, such an analysis presupposes a clear identification of normal from pathological cases, and this appears to be lacking. The sole criterion for the diagnosis of HCM is "the presence of a hypertrophied and non-dilated left ventricle in the absence of other diseases that could produce the same magnitude of hypertrophy," based on an echocardiographic wall thickness equal to or greater than 15 mm in adult index patients and equal or greater to 13 mm in adult relatives.
Given the exclusion of patients with symptoms or evidence with systolic dysfunction, there seems little to exclude the possibility that the individuals identified are not simply exceptionally well-trained endurance athletes, and that what is being examined is simply the ability of the 2 sets of ECG criteria to identify a person who has developed a large heart. It is particularly disturbing that the supposed diagnostic criteria seems to make no allowance for age, body size and sex, all of which undoubtedly influence the range of normal cardiac dimensions.
REF...
Show MoreWe want to thank Boynton et al. for writing a letter to the editor (LTE) in response to our recent editorial on gender disparities in the sport and exercise medicine (SEM) community [1]. As the title of our editorial indicates [We need to talk about manels: the problem of implicit gender bias in sport and exercise medicine], we were primarily motivated to stimulate a conversation about the issues we raised, and an LTE contributes to this conversation [2].
We were also motivated by a desire to assert that i) the SEM community does indeed manifest many examples of gender disparity; ii) social media has provided a space where this issue is being debated, notably (but not exclusively) under the hashtag #manels; iii) implicit bias is a significant contributor to these disparities, and iv) there exist well-established resources where interested readers might explore their own implicit biases [3].
It is in these goals, then, that we fundamentally disagree with most of the assertions the LTE authors have made about our work and the conclusions they draw.
We noted with interest that the authors of the LTE did not take direct issue with our assertion that there exist substantial gender imbalances within the field of SEM. Rather, they took issue with our assertion that implicit gender bias underpins these imbalances.
We posit in our editorial that implicit bias is a factor contributing to the gender disparities we see in SEM. Discussing implicit bias in t...
Show MoreIn their International Olympic Committee consensus statement, Maughan et al. reviewed the evidence for dietary supplements for high-performance athletes [1].
They wrote in regard to zinc that “Cochrane review shows benefit of [using] zinc acetate lozenges (75 mg) to decrease duration of URS [upper respiratory symptoms]” [1, Table 4]. This statement was based on their reading of the Cochrane review (2013) by Singh and Das [2], which was withdrawn in 2015 because of plagiarism [3]. In addition, the same Cochrane review had a large number of other severe problems [4]. In the above statement, Maughan et al. imply that only zinc acetate lozenges are effective; however, a recent meta-analysis showed that, up until 2017 at least, there was no evidence that zinc gluconate lozenges are less effective than zinc acetate lozenges [5].
When discussing treatment effects, the size of the effect and its confidence interval should be considered [6]. Thereby a critically-minded reader can form his or her own opinion about whether the treatment effect is relevant. The data of 7 placebo-controlled double-blind RCTs showed that zinc acetate and zinc gluconate lozenges shortened common cold duration on average by 33% (95% CI 21% to 45%) [5]. Individual-patient data were available for 3 zinc acetate lozenge trials and on the basis of these findings, zinc lozenges shortened the duration of colds by 2.7 days (95% CI 1.8 to 3.3 days) [7], and increased the rate of recovery by RR = 3....
Show MoreI would like to raise some comments regarding the paper ‘Foot orthoses for plantar heel pain: a systematic review and meta-analysis.’ Whittaker et al, 2018, Br J Sports Med. 52(6): 322-328, and the editorial ‘Foot orthoses research: identifying limitations to improve translation to clinical knowledge and practice’, Griffiths & Spooner 52(6) in the same edition.
I would like to applaud the intention of the paper by Whittaker et al, to try and establish a conclusion to the question of foot orthoses efficiency in treating heel pain symptoms. This same praise I also give to the editorial in bring into the discussion the potential issue of the validity of random control trials as a research method to test foot orthoses efficiency. However, some key issues with the paper need exploring beyond the issues raised in the editorial in regarding how orthoses may work.
There are several key issues with the paper by Whittaker et al, which overall is a noble attempt to make sense of the present research on using orthoses for plantar heel pain. The issues are; plantar heel pain is a symptom not a diagnosis (therefore some of these studies may include multiple conditions); the studies are subject to potential bias (addresses by the authors); the studies do not compare like with like studies and seemed to have been shoe horned together to achieve a conclusion; and finally, foot orthoses do not logically conform to randomised control trials. Despite the best efforts of th...
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