Defending My Position On Orthoses

Our profession needs to keep an open mind in regard to shoes and treating running injuries. People do not change what they are doing unless they have a reason to change. I continue to see runners not responding to orthotics and stability control shoes in my practice so I have provided a change, one that is working for others and myself. Of course, there is not a preponderance of evidence to support this change but there are emerging studies that support my thinking regarding the use of minimalist shoes. I have cited these studies in the past and will continue to do so. If the prior literature on orthotics were conclusive about their effectiveness, I would not be so strong-minded in my approach. I still feel there is a lack of clarity and consensus in the literature to support the use of orthotics.

Can orthotics work? Absolutely. How and what exactly do they do? It is very difficult to prove given the variability of one’s form, training pattern, shoe gear, strike pattern, biomechanics, body weight, training intensity and change in surfaces. My stance is that orthotics can treat an injury but this is a very haphazard approach. I think they are a crutch for treating the underlying problem, which may be overuse, poor form, weak musculature or improper training patterns.

I use orthotics in my practice, albeit rarely. I have found that by spending more time educating my patients on proper training patterns, form, foot strike, surface consistency, strengthening and shoe gear, I can make more of a difference in improving their injury. It can be more time consuming and challenging, but very gratifying. I do not encourage patients to discontinue using an orthotic if it is working for them. Again, I find this is very rare in my practice as most of the patients I see have already failed this type of therapy. The same applies to traditional running shoes. Many of the runners I train with wear traditional running shoes (yes, even ASICS) and I do not persuade them otherwise if it is working for them.

I love running, podiatry and making a different in people's lives. I am trying to change the way we think of feet in our society. We live in a society that has the stigma that we need to support and cushion our feet, which has yet to be proven. Shoes have evolved with no basis of evidence as to why a raised heel is present among many other features. I encourage others to be open-minded and consider my approach. I certainly have leaned more about orthotics and minimalist shoes as a result of being challenged by my colleagues. Thank you for stimulating my interest and encouraging me to read more.

Reviewing The Research On Orthoses

In regard to providing references to reinforce my opinions, I have done so in the past. Remember, I am speaking in regard to a paradigm change. We only have so much published on the new treatment and approach to running injuries as well as everyday foot pain and leg pain.

However, there is literature, both past and current, to support my opinions. Richter and colleagues conducted a meta-analysis of 23 randomized controlled trials on the use of orthotics for lower limb overuse conditions.1 The authors noted that the evidence does support using orthoses to prevent a first incident of lower limb overuse conditions but their meta-analysis found no difference between custom and prefab devices. The study authors noted “the evidence was insufficient to recommend foot orthoses (custom or prefabricated) for the treatment of lower limb overuse conditions.”

In looking at the efficacy of foot orthotics in the treatment of knee and hip osteoarthritis in 2008, Gelis and colleagues found “no evidence of a structural or functional impact on osteoarthritis (Grade B).”2 The authors also noted “no validated indication for prescribing foot orthotics in the treatment of knee or hip OA.”

We have even seen authors challenge Root’s philosophies. McPoil and Cornwall found that contrary to Root's published theory, the “neutral” position of the rearfoot for the typical pattern of rearfoot motion during the walking cycle was resting standing foot posture rather than the subtalar joint neutral position.3 McPoil and Hunt further challenged Root's theories on evaluation and treatment, and suggested an alternative “tissue stress model” for assessing and managing foot disorders.4

While Jarvis and colleagues noted the importance of static biomechanical assessment of the foot, leg and lower limb, they found that the key examinations physicians use to assess dynamic foot function and determine orthotic prescription are “unreliable.”5

Further Insights On The Relevant Literature

Several studies showing beneficial effects for orthoses were subjective in the form of surveys sent to patients.6-8

Gross and coworkers looked at 15 people with plantar fasciitis and found they could walk 100 meters with less pain by wearing an orthotic.9 This was not a long-term follow-up and in fact, the longest amount of time of wearing the device before testing was only 17 days. The study authors conclude that “custom semi-rigid foot orthotics may significantly reduce pain” during walking but these results were also subjective as they were based on patients rating their pain with the visual analogue scale and completing a questionnaire.

In a retrospective review, Saxena and Haddad looked at 102 patients with patellofemoral pain syndrome who wore orthotics and used multiple other modalities.10 They found 76.5 percent of the patients improved at the follow-up visit. Although the authors noted the use of semi-flexible orthoses was significant, we can make no direct correlation to the orthotic device given that the treating physicians used multiple modalities for these patients.”

Kilmartin and Wallace reviewed the literature to assess biomechanical foot orthoses in the treatment of lower limb sports injuries.11 In the article abstract, they note that “a review of the literature indicates that biomechanical orthoses will reduce rearfoot movement, but the effect on knee function is negligible and the clinical significance of excessive rearfoot movement is yet to be proven.”

Shih and colleagues looked at 24 runners with a pronated foot and knee pain who experienced pain relief with a medial wedge orthotic while running on a treadmill for 60 minutes.12 The follow-up was at two weeks so it difficult to draw any long-term conclusions from this study.

In a cohort-controlled trial, Ferrari examined the efficacy of orthotics in the treatment of trochanteric bursitis.13 He noted a 90 percent improvement in patients who received orthotics and a corticosteroid injection to the trochanteric bursa with fluoroscopic guidance in comparison to a 40 percent improvement in patients who had the injection only over a four-month period. Essentially, this study suggested that the placement of a rigid device in a shoe may facilitate pain relief for those with hip pain. How?

In a 2011 randomized, controlled trial involving 400 military trainees, Franklyn-Miller and colleagues demonstrated a 10-time reduction in medial tibial stress syndrome and a 7-time reduction in chronic exertional compartment syndrome with the use of orthoses.14 Overall, the authors noted an absolute risk reduction of 0.49 with the use of orthoses. However, it was not clear from the study how the orthoses were preventing injury and what the devices were doing from a clinical standpoint.

In contrast to this study was another study published in 2011 by Mattila and colleagues, who looked at the role of orthotic insoles in preventing lower limb overuse injuries.15 In this randomized, controlled trial involving 228 patients, they found that the “use of orthotic insoles was not associated with a decrease in lower limb overuse injuries.”

In another randomized, controlled trial involving 179 patients, Collins and coworkers examined the use of orthoses and physiotherapy for people with patellofemoral pain syndrome.16 While patients perceived foot orthoses as being superior to flat inserts, the researchers found no significant difference in combining orthoses with physiotherapy. In other words, adding orthotics to the physical therapy already prescribed produced no further improvements. This study demonstrated that active therapy can improve patellofemoral pain without relying on a permanent orthotic device.

In 2011, Mills and coworkers examined the short-term efficacy of orthoses in patients with anterior knee pain.17 This was a extremely short-term study of six weeks involving 40 patients with patients subjectively classifying an improvement in symptoms with prefabricated orthotics in comparison to no treatment at all.

What The Literature Reveals About Stress Fracture Risk

Assessing both semi-rigid and soft orthoses in the prevention of stress fractures in military recruits who wore “infantry boots with soles designed like those of basketball shoes,” Finestone and colleagues found that 10.7 percent of patients with soft orthotics developed stress fractures, 15.7 percent of patients with semi-rigid orthoses developed stress fractures and 27 percent of the control group developed stress fractures.18 It is interesting to see the high rates of stress fractures in all three groups in this study in comparison to the reported average incidence of stress fractures occurring in runners. Tenforde and colleagues reported a stress fracture incidence ranging between 4 to 5 percent in adolescent runners.19 Tuan and coworkers noted a stress fracture incidence rate between 4.4 to 15.6 percent in athletes.20

Researchers have also demonstrated a 3 to 6 percent reduction in stress fracture risk by shortening your stride.21 Shortening one’s stride is associated with minimalist shoes, which were proven to reduce strike impact in a recently published study.22

In Conclusion

The studies I discussed above are not selective representation of articles to support my opinions. My opinions are based on some of the articles and research provided by Kevin Kirby, DPM, in response to my last blog (see http://www.podiatrytoday.com/blogged/can-minimalist-shoes-be-beneficial-... ) as well as the research and literature I have read and continue to read.

In summary, my opinions on the use of orthotics for treating runners are based on the lack of definitive evidence as to their exact role. This leads me to be open-minded in my approach to treating running injuries. There is an enormous amount of variance in factors that can contribute to running injuries and the aforementioned studies seem to raise more questions than they answer on orthotic intervention.

For example, to rely on symptoms of greater trochanteric bursitis improving after wearing a shoe orthotic does not render any evidence as to why. Of course, we can see gait changes by using an orthotic but we can also see gait changes in runners by implementing a more natural style of running which involves landing at or near below the center of gravity of the body on the midfoot. Striking in this manner all but negates the need for any orthotic because there is minimal concern on controlling rearfoot motion. I have yet to see any study comparing orthotics to using a midfoot or forefoot strike pattern along with improved running form for treating injuries.

We need to collectively move forward with progressive thinking and challenge new and old theories. My opinions are based on current and past literature, and are not biased in regards to any shoe company, specifically Vibram USA.

In regard to my alleged ulterior motive to market FiveFingers shoes (Vibram USA), they are and continue to be a training tool for me in running. Having the opportunity to sample running shoes, I tend to train and run in a lot of different types of shoes. I recently ran a marathon in a pair of New Balance RC5000s. However, to be clear, I have no financial interest in any of the shoe companies.

It is very disheartening to see my colleagues belittle my attempts at progressive treatment options that are in current use to treat runners. We can see that as a result of the popularity of minimalist shoes as well as the lowering in heel height of traditional running shoes, a change has occurred in the running shoe industry. In my clinical experience, those involved in the sport of running are now beginning to focus more on form than on footwear itself. This is changing the way we all run and will soon change podiatry for the positive.

Editor’s note: Dr. Campitelli has disclosed that he is an unpaid Medical Advisor to Vibram USA.

References

1. Richter RR, Austin TM, Reinking MF. Foot orthoses in lower limb overuse conditions: a systematic review and meta-analysis--critical appraisal and commentary. J Athl Train. 2011;46(1):103-6.

2. Gélis A, Coudeyre E, Hudry C, Pelissier J, Revel M, Rannou F. Is there an evidence-based efficacy for the use of foot orthotics in knee and hip osteoarthritis? Elaboration of French clinical practice guidelines. Joint Bone Spine. 2008;75(6):714-20.

3. McPoil T, Cornwall MW. Relationship between neutral subtalar joint position and pattern of rearfoot motion during walking. Foot Ankle Int. 1994;15(3):141-5.

4. McPoil TG, Hunt GC. Evaluation and management of foot and ankle disorders: present problems and future directions. J Orthop Sports Phys Ther. 1995;21(6):381-8.

5. Jarvis HL, Nester CJ, Jones RK, Williams A, Bowden PD. Inter-assessor reliability of practice based biomechanical assessment of the foot and ankle. J Foot Ankle Res. 2012 Jun 20;5:14.

6. Donatelli R, Hurlburt C, Conaway D, St. Pierre R. Biomechanical foot orthotics: A retrospective study. J Ortho Sp Phys Ther, 1988; 10(6):205-212.

7. Moraros J, Hodge W. Orthotic survey: Preliminary results. J Am Podiatr Med Assoc. 1993; 83(3):139-148.

8. Walter JH, Ng G, Stoitz JJ. A patient satisfaction survey on prescription custom-molded foot orthoses. JAPMA. 2004;94:363-367.

9. Gross MT, Byers JM, Krafft JL, et al. The impact of custom semi-rigid foot orthotics on pain and disability for individuals with plantar fasciitis. J Ortho Sports Phys Ther. 2002; 32(4):149-157.

10. Saxena A, Haddad J. The effect of foot orthoses on patellofemoral pain syndrome. J Am Podiatr Med Assoc. 2003; 9(4):264-271.

11. Kilmartin TE, Wallace WA. The scientific basis for the use of biomechanical foot orthoses in the treatment of lower limb sports injuries-a review of the literature. Br J Sports Med. 1994; 28(3):180-184.

12. Shih YF, Wen YK, Chen WY. Application of wedged foot orthosis effectively reduces pain in runners with pronated foot: A randomized clinical study. Clin Rehab. 2011; 25(10):913-923, 2011.

13. Ferrari R. A cohort-controlled trial of customized foot orthotics in trochanteric bursitis. J Prosth Orthotics, 2012;24(3):107-110.

14. Franklyn-Miller A, Wilson C, Bilzon J, McCrory P. Foot orthoses in the prevention of injury in initial military training. A randomized controlled trial. Am J Sports Med. 2011; 39:30-37.

15. Mattila VM, Sillanpää PJ, Salo T, Laine HJ, Mäenpää H, Pihlajamäki H. Can orthotic insoles prevent lower limb overuse injuries? A randomized-controlled trial of 228 subjects. Scand J Med Sci Sports. 2011 Dec;21(6):804-8.

16. Collins N, Crossley K et al. Foot orthoses and physiotherapy in the treatment of patellofemoral pain syndrome: randomised clinical trial. Br J Sports Med. 2009; 43:169-171.

17. Mills K et al. A randomised control trial of short term efficacy of in-shoe foot orthoses compared with a wait and see policy for anterior knee pain and the role of foot mobility. Br J Sports Med. 2011;46:247-252.

18. Finestone A, Giladi M, Elad H, et al. Prevention of stress fractures using custom biomechanical shoe orthoses. Clin Orth Rel Research. 1999;360:182-190.

19. Tenforde AS, Sayres LC, Liz McCurdy M, Sainani KL, Fredericson M. Identifying sex-specific risk factors for stress fractures in adolescent runners. Med Sci Sports Exerc. 2013 Apr 11 (Epub ahead of print)

20. Tuan K, Wu S, Sennett B. Stress fractures in athletes: risk factors, diagnosis, and management. Orthopedics. 2004;27(6):583-91, quiz 592-3.

21. Edwards WB, Taylor D, Rudolphi TJ, Gillette JC, Derrick TR. Effects of stride length and running mileage on a probalistic stress fracture model. Med Sci Sports Exerc. 2009;41(12):2177-84.

22. Giandolini M, Horvais N, Farges Y, Samozino P, Morin JB. Impact reduction through long-term intervention in recreational runners: midfoot strike pattern versus low-drop/low-heel height footwear. Eur J Appl Physiol. 2013 Apr 14. (Epub ahead of print)



Tabris Wongsays: May 15, 2013 at 10:31 am

The main problem on orthotic research is that there are too many professions that think that by casting (or even foam-boxing) one's feet, then the thing they make would be equal to foot orthoses. I see many so-called foot orthoses with too many arch fill, or forefoot wedge which is not necessary, or ultra-soft shell materials that are not supportive enough.

So it is very easy for someone to disprove the functions of foot orthoses. Simply make bad orthotics to do the test.

Just my two cents.

Reply to this comment »
Kenneth Craigsays: May 16, 2013 at 6:45 am

A fresh breeze blowing to help clear foggy minds. Well done Nick. I am in agreement with your views and research data posted in your article. I could never justify the cost involved with customized orthoses when OTC ones work as well. Given there are cases that require the customization but these orthoses when objectively assessed are less frequently needed than what is being dished out.

Addressing the muscular weakness / imbalances occurring in the various regions is far more effective in the long term rather than introducing a crutch such as orthoses which could lead to further weakening of the musculature over time.

It also annoys me to see or hear of podiatrists conducting biomechanics assessments in narrow, dimly lit corridors and observation restricted to frontal plane only. This is "coning" patients at the core of it! Human kinesiology occurs in 3D where the kinetimatics, kinetics and energetics need to be assessed in order to obtain an understanding of what is occurring. This cannot be assessed in the manner highlighted earlier.

My few cents worth as well and once again, well done Nick.

Reply to this comment »
Simon K. Spooner PhDsays: May 16, 2013 at 3:48 pm

See my opinions on current foot orthoses research methodology discussed in this paper published here: http://fas.sagepub.com/content/5/5/334.full

Reply to this comment »
Craig Paynesays: May 16, 2013 at 5:44 pm

There is no paradigm change happening. The minimalism fad is over. The bubble has burst. The fat lady has sung.

It has been a very bad week for those that tout minimalism as a panacea.

1. At next week's ACSM meeting, there are six papers on running economy in traditional shoes and minimalist shoes. All six found no differences.

2. At the same meeting, there are two large studies looking at injury rates between traditional shod runners and minimalist runners. There were no differences.

3. In the first quarter of 2013, sales of minimalist shoes have dropped 10% to only having a tiny 4% market share. Motion control shoe sales are up 25%! In contrast to Dr Campitelli's claims, minimalism is not popular. Runners have voted with their feet.

In contrast, every single clinical outcome study, including a Cochrane Review, has shown foot orthotics work (except one on bunions in kids). I see no Cochrane Reviews on minimalism.

"The studies I discussed above are not selective representation of articles to support my opinions."

Actually, they are. This is cherry picking at its worst and anyone familiar with that body of literature can see it.

Reply to this comment »
nickcampisays: May 21, 2013 at 6:47 am

Craig,

For a more clear understanding of minimalist shoes and how sales are determined, see Pete Larson's article/post at
http://www.runblogger.com/2013/05/2013-running-shoe-sales-data-what-do.html

You're referring to the Sports One Source ( http://www.sportsonesource.com/) data which is actually based on sales, not what "runners" are actually wearing.

Reply to this comment »
Craig Paynesays: May 16, 2013 at 11:11 pm

@Kenneth

"which could lead to further weakening of the musculature over time."

Then how do you explain that all the studies that have looked at this that say it does not happen? In fact, two of them say the opposite. Have you even read those studies or did you just say that as you want it to be true?

I prefer to go where the scientific evidence takes me rather than just wishing things were true.

Reply to this comment »
Kenneth Craigsays: May 27, 2013 at 5:23 pm

Fair comment.

To say that orthoses do or do not introduce long term weakness is yet to be clearly established as there are yet to be long-term outcomes proving or disproving this (please, if there are, let me know). Therefore, the only way to settle this issue is conduct some long-term studies.

I am not opposed to the use of orthotics but am more concerned as to when and where to intervene with them appropriately. When I do, my choice is OTC vs customized (once again my choice).

I will be conducting some studies using EMG, FMD-P's, IMU's and other quantitative instruments that we have recently fitted at our clinics to determine mid- to long-term treatment outcomes (not just insoles, but for every other intervention that we choose to provide). This is part of our clinical outcomes and treatment survival measurements process. We usually conduct an 18-month follow-up on patients anyway, but this will add a quantitative measure to an otherwise purely subjective entity. Hopefully, some meaningful data may emerge.

Another point to clarify is that I am not a fan of barefoot running. I merely agreed with Nick's comments on the risks of potentially introducing long-term muscle weakness.

Reply to this comment »
Simon K. Spooner PhDsays: May 17, 2013 at 3:34 am

See this article too, which was published today: http://www.jfootankleres.com/content/pdf/1757-1146-6-19.pdf

Reply to this comment »
Ian B Griffithssays: May 17, 2013 at 4:24 pm

@Kenneth

"Human kinesiology occurs in 3D"

Actually, its 4D.

Reply to this comment »
Kenneth Craigsays: May 27, 2013 at 4:58 pm

Thanks for your correction.

When i was referring to 3D, I was thinking about triad of referential axes (frontal-horizontal; sagittal-horizontal & vertical). Also at the present moment, all our clinical assessments using digital IMUs, etc., are only capable of 3D recognition.

So please let me know if you are using a system capable of 4D measurements as I would love to look into it.

Reply to this comment »
Kevin A. Kirby DPMsays: May 18, 2013 at 12:01 am

I find it very interesting now that since Dr. Campitelli has finally read the literature I referenced on foot orthoses that he has changed his opinion on foot orthoses.

Let's look at what Dr. Campitelli stated in his previous blog:

"Despite the fact that literature does not support the use of foot orthotics for conditions such as plantar fasciitis, shin splints, knee pain, iliotibial band syndrome, piriformis syndrome and many other running injuries, an overwhelming number of physicians and healthcare providers implement orthoses in their practice."

Now let's look at an example of what Dr. Campitelli says since he finally took the time to read the literature on the subject he was blogging on:

"In a 2011 randomized, controlled trial involving 400 military trainees, Franklyn-Miller and colleagues demonstrated a 10-time reduction in medial tibial stress syndrome and a 7-time reduction in chronic exertional compartment syndrome with the use of orthoses.14 Overall, the authors noted an absolute risk reduction of 0.49 with the use of orthoses. However, it was not clear from the study how the orthoses were preventing injury and what the devices were doing from a clinical standpoint."

Wait, Dr. Campitelli. Are you now saying that you were wrong in your last blog when you said "Despite the fact that literature does not support the use of foot orthotics for conditions such as plantar fasciitis, shin splints...." ? Certainly you can't say that the literature does not support the use of foot orthotics in one blog and then say it does support the use of foot orthotics in the next blog, and not expect us to be confused by your flip-flopping of opinion on the therapeutic effectiveness of foot orthoses from one week to another.

Please explain yourself, Dr. Campitelli. Which is right?

1. The literature does not support the use of foot orthotics for the treatment of certain pathological conditions of the foot and lower extremity. http://www.podiatrytoday.com/blogged/can-minimalist-shoes-be-beneficial-...

or...

2. Foot orthoses have been shown in the scientific literature to support the use of foot orthotics for the treatment of certain pathological conditions of the foot and lower extremity.
http://www.podiatrytoday.com/blogged/defending-my-position-orthoses

By the way, only one of your opinions can be right since your two opinions above, made three weeks apart from each other, are mutually exclusive of each other. Which one, #1 or #2 above, is right?

In regard to Dr. Campitelli being an "Unpaid Medical Advisor to Vibram USA," Dr. Campitelli along with Daniel Lieberman, PhD (funded by Vibram in multiple research studies) were both listed as contributors to the 13-page "Step by Step Guide" of how to run, without getting injured, in Vibram FiveFingers shoes.

http://s3.amazonaws.com/VibramFiveFingers/Barefoot_Running_Brochure_R13_...

In the history of running shoes, there has never been such an extensive manual on how to run in a shoe "properly." Really, doesn't it say something about the increased injury risk of a running shoe when the shoe company feels compelled to publish a 13 page "Step-by-Step Guide" just so its runners won't get injured in the company's shoe??

Amazing!

Kevin A. Kirby, DPM
Adjunct Associate Professor
Department of Applied Biomechanics
California School of Podiatric Medicine

Reply to this comment »
Nick Campitellisays: May 21, 2013 at 10:15 am

I think my thoughts are pretty clear if you read my posts. I prefer the natural strengthening approach as well as form correction in regard to solving a running injury. As for orthotics, they're a mere shotgun approach to fixing a problem in my view. I don't think I have changed my opinion at all actually. I just clarified how I interpreted the literature.

Reply to this comment »

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