I think I've heard it stated a few times now (I think by Craig) that all studies of foot orthoses have found a positive influence of these devices on clinical outcomes. Can anyone provide a list of these studies, please? Indeed, can anyone list a study which did not show a positive influence of foot orthoses on clinical outcomes?
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Here are the 3 that Craig mentions most often:
Blake, R. L., & Denton, J. A. (1985). Functional foot orthoses for athletic injuries: A retrospective study. Journal of the American Podiatric Medical Association, 75, 359-362.
Orthoses definitely helped 70% of subjects
78% reported improved posture with their devices
Donatelli, R. A., Hurlbert, C., Conaway, D., & St Pierre, R. (1988). Biomechanical foot orthotics: a retrospective study. The Journal of Orthopaedic and Sports Physical Therapy, 10, 205-212.
53 subjects; retrospective survey
96% reported pain relief with their orthoses
94% still wearing their orthoses
52% ‘would not leave home without them’
Moraros, J., & Hodge, W. (1993). Orthotic survey: Preliminary results. Journal of the American Podiatric Medical Association, 83, 139-148.
523 subjects; prospective survey
83 % satisfied at 14/52 post issue
63% symptoms completely resolved
95% symptoms completely or partially resolved -
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Here's one that didn't... For anyone who's never read it:
http://etheses.nottingham.ac.uk/1917/1/261039.pdf -
Embarrassingly I do not have a list of them! Been meaning to compile one for a while. I think Kevin has a list of them, so maybe he will share and we can check it and add to it if necessary.
Those 3 I use above are just 3 I randomly picked from my file to illustrate the point I try to make.
Effectively the point is that every single patient satisfaction study, clinical outcome study, randomized controlled trial has shown foot orthotics work.
Some of them are old, some of them have bad methodology and other issues, some of the RCT shows orthotics were no better than other interventions, but the orthotic group still got better and did better than placebo.
Despite that, NONE of them have shown that orthotics did not work!
Kinda don't figure that so many claim they don't work ?????
If you look at the figures in all the studies, the success rates of foot orthotics are not really different to any other intervention ... eg knee replacement surgery; antibiotic for strep throat... etc etc
A list of them would be good if someone is willing to share. -
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Here is a few more;
COLLINS, N., BISSETT, L., McPOIL, T., VICENZINO, B., 2007. Foot orthoses in lower limb overuse conditions: a systematic review and meta-analysis. Foot Ankle Int. 28(3):396–412.
COLLINS, N., CROSSLEY, K., BELLER, E., DARNELL, R., McPOIL, T., VICENZINO, B., 2009. Foot Orthoses and physiotherapy in the treatment of patellofemoral pain syndrome: randomised clinical trial. Br SportsMed;43(3),169-171
ROME, K., BROWN, CL., 2004. Randomised clinical trial into the impact of rigid foot orthoses on balance parameters in excessively pronated feet. Clin Rehab, 18(6), pp.624-230.
WOODBURN, J., BARKER, S., HELLIWELL, PS., 2002. A randomized controlled trial of foot orthoses in rheumatoid arthritis. J Rheum, 29(7), pp.1377-1383.
And I think this Hume et al study finds only slim evidence orthotics are useful in treating or preventing certain lower limb injuries
HUME, P., HOPKINS, W., ROME, K., MAULDER, P., COYLES, G., NIGG, B., 2008. Effectiveness of foot orthoses for the treatment and prevention of lower limb injuries: A review. Sports Medicine, 38(9), pp.759-779. -
Thanks for the Kilmartin paper - not read this first hand before.Attached Files:
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Collins 2007 - Foot orthoses in overuse injuries - a meta-analysis.pdf
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For the list
Attached Files:
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Foot orthoses and physiotherapy in the treatment of patellofemoral pain a randomised trial copy.pdf
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Two more that may be of interest
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Hope this helps.:drinks
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Thanks Kevin. Am I right in assuming these are all studies which demonstrate a positive outcome?
I note that, for example the Kilmartin RCT http://web.jbjs.org.uk/content/76-B/2/210.full.pdf and the Landorf RCT http://www.formthotics.com/images/s..._Foot_Orthoses_to_Treat_Plantar_Fasciitis.pdf are not included in your list.
Do you have a similar list of papers where the outcomes may not have been positive or no better than a.n. other? -
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I'm interested in avoiding selective evidencing- so do we have a list of negative outcomes / no better than X outcomes? -
This one, I think, has both type of outcomes :
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 Jan-Feb;46(1):103-6
Conclusions: The evidence supports the use of foot orthoses to prevent a first occurrence of lower limb overuse conditions and shows no difference between custom and prefabricated foot orthoses. The evidence was insufficient to recommend foot orthoses (custom or prefabricated) for the treatment of lower limb overuse conditions.
Daniel -
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shows no difference between custom orthoses of the type used in the studies that are not actually used in clinical practice and prefabricated foot orthoses -
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It’s enough to have reported positive/negative outcomes or them has to be related to the level of evidence ?
- DJ Pratt, A critical review of the literature on foot orthoses, JAPMA July 1, 2000 vol. 90 no. 7 339-341
Results : “ A total of 40 references were studied for this review. The perhaps surprising finding was that only one achieved better than a C grade. All of the others fell under Sackett’s levels 3 to 5. In fact, many of the reports were so anedoctal that they failed even to reach Sackett’s level 5”
The only one with higher level of evidence was Kilmartin RCT http://web.jbjs.org.uk/content/76-B/2/210.full.pdf , mentioned above
Daniel -
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This posting, IMHO, sums up the three years since you first published my application for my patents that was submitted four years before when it comes to the evidence that you have produced, amassed, discovered and searched for related to YOUR custom foot orthotics and the manner and intensity which you have investigated, discovered and searched Functional Foot Typing. In this time, you have not come up with anything that has shown your paradigm to be superior nor mine to be inferior.
Summarily, why do so many claim that my patented foot centering theory does not work or even worse?
So let's see where your evidence based and theoretically unbiased mind positions itself in the world of YOUR custom foot orthotics.
I would like to call them:
Craig Paynes SALRE, Tissue Stress Foot Orthotic Evidence Five (5) Postulates and submit them to scrutiny
1. Foot Orthotics do good things when poorly researched and anecdotally evaluated.
They Work!
2. The studies that exist that support our theories are "old, have bad methodology and other issues
3. Orthotics got better and did better than placebo
4. The success rates of foot orthotics are not really different to any other intervention
5. There is no strong evidence that proves that our foot orthotics don't work
IMHO, you believe that your opinion, armed with paultry evidence and science, places you and yours as the judges of the rest of the scope of biomechanics postured as the judges, the jury and the leaders of the field.
As The Arena, your opinions represents a narcissistic, arrogant, biased, profit motivated, egomaniacal and self validating (all things you have called me on these pages), cult-like group.
Dennis -
Custom Foot Orthotics Have Little High Level Evidence: Upgrading Please
The Cochrane Collaboration Study of its Cochrane Musculaoskeletal Group in 2008 published:
Hawkes F, Burns J, Radford J, du Toit, V: Custom-made foot orthoses for the treatment of foot pain, 16 JUL 2008, online published
In its plain language summary the study stated:
This summary of a Cochrane review presents what we know from research about the effect of custom-made foot orthoses for the treatment of foot pain;
The review shows that in adults who have had painful pes cavus (high arch), for more than one month custom foot orthoses:
Decreases foot pain after 3 months compared with fake foot orthoses.
The review shows that for people at least 5 years of age and diagnosed with juvenile idiopathic arthritis (JIA), custom foot orthoses:
Reduce foot pain after 3 months compared with supportive shoes, but do not reduce foot pain after 3 months compared with using prefabricated neoprene shoe inserts.
The review shows that in adults with rheumatoid arthritis (RA), custom foot orthoses:
Reduce rearfoot pain after 3 months, compared with doing nothing, but do not reduce foot pain after 3 years, compared with using fake foot orthoses.
May not reduce pain in the metatarsophalangeal joint (where the big toe meets the foot) after 6 weeks or 3 months any more than wearing supportive shoes or using soft non-custom foot orthoses.
The review shows that for people diagnosed with plantar fasciitis (heel pain), custom foot orthoses:
May not reduce foot pain after 3 or 12 months any more than using fake foot orthoses
May not reduce foot pain after 6 weeks or 3 months any more than using night splints to hold your feet in a stretched position while you sleep. However, using custom foot orthoses and night splints together may reduce foot pain.
May not reduce foot pain after 2-3 months or 1 year any more than non-custom foot orthoses
May not reduce foot pain after 6-8 weeks when used along with a program of stretching exercises or night splints.
May not reduce foot pain after 2 weeks any more than a combined treatment of manipulation, mobilisation and stretching.
This review shows that for people younger than 60 years of age with painful hallux vagus (a condition where the base of the big toe bulges out sideways, away from the foot) custom-made foot orthoses:
Reduce foot pain after 6 months compared to no treatment, but may not reduce foot pain after 6 or 12 months compared to surgery.
Safety of custom foot orthoses
We often do not have precise information about side effects and complications. This is particularly true for rare but serious side effects. Reported adverse effects included additional foot pain, ankle instability and skin irritation.
What are custom foot orthoses and what is foot pain?
This review focuses only on custom ('custom-made') foot orthoses, which are defined in this review as contoured, removable in-shoe devices that are moulded or milled from an impression of the foot (for example a plaster cast, three-dimensional laser scan) and fabricated according to practitioner-prescribed specifications.
Foot pain may be experienced following an injury; long-term overuse; infection; or systemic disease involving any tissue of the foot, including bones, joints, ligaments, muscles, tendons, nerves, skin, and nails. Foot pain can be generalised or more specifically diagnosed according to location (for example heel pain), structure (for example tendon or ligament damage) or condition (for example osteoarthritis).
Best estimate of what happens to people with foot pain caused by a high arch who use custom foot orthoses compared to a fake foot orthoses:
After 3 months, a custom-made foot orthoses improves foot pain by 11 more points on a scale of 0 to 100 (possibly as many as 19 points or as few as 3 points).
Best estimate of what happens to people with RA who have foot pain and who use custom foot orthoses compared to wearing supportive shoes or doing nothing:
After 3 months, custom-made foot orthoses improve foot pain by 14 more points on a scale of 0 to 100 (possibly as many as 23 points or as few as 5 points).
After 2 and a half years, custom-made foot orthoses improve foot pain.
Best estimate of what happens to children with JIA who have foot pain and who use custom foot orthoses compared to wearing supportive shoes:
After 3 months, custom-made foot orthoses improve foot pain by 19 more points on a scale of 0 to 100 (possibly as many as 36 points or as few as 3 points).
Best estimate of what happens to people with a painful bunion with hallux valgus who use custom foot orthoses:
After 6 months, custom-made foot orthoses improve foot pain by 9 more points on a scale of 0 to 100 (possibly as many as 17 points or as few as 1 point) compared to doing nothing.
After 6 months, surgery improved foot pain by 10 more points on a scale of 0 to 100 (possibly as many as 18 or as few as 2 points) compared to the custom foot orthoses.
After 12 months, surgery improved foot pain by 17 more points on a scale of 0 to 100 (possibly as many as 25 or as few as 9 points) compared to the custom foot orthoses.
The authors concluded:
There is limited evidence on which to base clinical decisions regarding the prescription of custom-made foot orthoses for the treatment of foot pain.
It seems as though the best evidence we can come up with in 40+ years after Dr Merton Root, a podiatrist, invented the custom foot orthotic is that it affects the kinetics and kinematics of the foot and posture "somehow", that it does no harm, that it works and that it works even better when utilized in a multifaceted program of care.
IMHO, our current custom foot orthotics remain valuable tools for foot and postural care when dispensed by capable practitioners but fall short of the necessary EBM to validate them as true scientific instruments.
This calls for a paradigm shift to be considered.
By this I mean that as most of us in the custom foot orthotic marketplace continue to faithfully develop, search for, practice, research and seek out higher level evidence for the existing gold standard of custom foot orthotics, we need to develop, search for, practice, research and seek out other interventional concepts for managing foot pain with devices in a less biased manner then we have in the past.
The reason for this is that some of the answers to producing custom foot orthotics with high level EBM may live "out of the box".
I predict that more open minded and broader investigation will advance custom foot orthotic care and our ability to provide EBM for them.
Dr Sha -
There is no published description of how orthoses are varied based upon different foot types. Since I've asked you numerous times how, and why, you vary the orthotic based on your foot typing scheme, and you haven't answered, I can only assume that you don't vary the device based on the type. If you don't vary the device based on foot type then there is no point to typing the foot.
I'm not saying that your orthotics don't work. I am saying there is no logical explanation for why your orthotics work. Over the counter arch supports work. Dennis, you have never explained why you think a foot typed orthosis is better than an over the counter one. I doubt you can.
Eric -
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Eric
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