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Effect of custom-made foot orthoses in female hallux valgus after one-year follow up.
Reina M, Lafuente G, Munuera PV.
Prosthet Orthot Int. 2012 Jun 12.

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What were the design characteristics of the foot orthoses employed?

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Who? What? When? Why? Yeah? And? So? What?

"My mission drive is to open up my eyes, 'cause the wicked lies and all the sh!te you say..." http://www.youtube.com/watch?v=V4NW5S1UTPQ

"Science is the antidote to the poison of enthusiasm and superstition."

Isn't that what Kilmartin found, 20 years ago?

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Honorary Research Associate, Institute for Human Evolution, University of Witwatersrand

Adjunct Associate Professor (Human and Comparative Anatomy), University of Western Sydney

Fellow of The Centre For Human Biology, The University of Western Australia

"Please God, deliver me whole from Creationists......."

Yes, that is a problem with these kinds of studies. Did the "custom" made orthotics have design features that there would be a consensus that they were the appropriate design features. Yes, he did, but it suffered from the same issue. I don't think there was any consensus that the orthotics that were used in the study had the design features considered appropriate. All that can be concluded from Tim's study and the one above, is that "custom foot orthotics, with the design features used in this study showed that .....". This does not mean that the same study repeated with custom foot orthotics with different design features would not get the same results or not, it just means we can't leap to blanket conclusions.

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Craig Payne
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Follow me on Twitter | Run Junkie | Latest Blog Post: Foot pronation is not associated with increased injury risk in novice runners wearing a neutral shoe
God put me on this earth to accomplish a certain number of things - right now I am so far behind, I will never die.

No mention of footwear either.

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http://www.davidmhollandpodiatry.co.uk

Is something missing from the results?

1. There was no significant difference in the initial measurements of both groups.
2. There was no significant difference in the follow up measurement of both groups.
3. There was no significant intragroup differences in initial and follow up measurements.


Does this mean that the HV did not evolve in either group over the 12 month period?


Bill

This had occurred to me too, Bill. I was waiting to see the full-text.

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Who? What? When? Why? Yeah? And? So? What?

"My mission drive is to open up my eyes, 'cause the wicked lies and all the sh!te you say..." http://www.youtube.com/watch?v=V4NW5S1UTPQ

"Science is the antidote to the poison of enthusiasm and superstition."

Let me put my 5 cents forward on this topic. At a few of the lectures I attended given by Dr. Mert Root, he said that foot orthoses were pretty much useless at preventing progression of hallux valgus deformity once the 1st intermetatarsal (IM) angle got over a certain angle (I believe he said about 13 degrees). From that angle on, there is no foot orthosis that could help slow progression of hallux valgus deformity.

Now, having 27 years of experience under my belt to add to Dr. Root's anecdotal observations, I can say that foot orthoses are very good at relieving the 1st MPJ joint pain of HAV, but, like Mert Root stated, I have not seen them help individuals with 1st IM angles ove 13-15 degrees at preventing progression of hallux valgus and bunion deformities. However, under 12-13 degrees of IM angle, a well-designed foot orthosis does have a chance of slowing progression of hallux valgus deformity, as long as it is not losing the battle of hallux valgus progression to the external hallux external rotation moments from pointy-toed or narrow shoe gear on a regular basis.

Anecdotal observations, yes,....... but certainly worth something in a topic that has so little research on it at this point in time.

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Sincerely,

Kevin

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Kevin A. Kirby, DPM
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Department of Applied Biomechanics
California School of Podiatric Medicine at Samuel Merritt College

e-mail: kevinakirby@comcast.net

Private Practice:
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Ladies and Gentlemen,

As a matter of historical interest, prior to the publication of A Controlled Prospective Trial of a Foot Orthosis for Juvenile Hallux Valgus in 1994 (full text at http://www.bjj.boneandjoint.org.uk/c...2/210.full.pdf), Dr. Kilmartin published a number of papers from his PhD data set including: Kilmartin TE, Wallace WA, Hill TW.: Orthotic effect on metatarsophalangeal joint extension. A preliminary study. J Am Podiatr Med Assoc. 1991 Aug;81(8):414-7.

In this paper, Kilmartin describes what he calls "a marginal" reduction in 1st MTPJ extension caused by his design of functional foot orthoses, which he says "may be of therapeutic value in the early stages of hallux rigidus, when restricting motion at the joint may slow or prevent development of subchondral sclerosis." He even presents a photograph of what the cut-out should look like. As part of his conclusion, he advises that all foot orthoses used in the treatment of juvenile HAV should incorporate a long first ray cut out to avoid a dorsiflexion force against the first metatarsal. The thing that baffled many observers at the time of publication was that despite this premiminary study, Kilmartin did not incorproate a first ray cut-out into the design of the foot orthoses used for his 1994 controlled prospective trial!

A number of studies have described the effect of foot orthoses on 1st MTPJ ROM:

Roukis TS, Scherer PR, Anderson CF: Position of the First Ray and Motion of the First Metatarsophalangeal joint. JAPMA, Vol. 86(11), 1996.

Hall C, Nester CJ: Sagittal plane compensations for artificially induced limitation of the first metatarsophalangeal joint: a preliminary study. J Am Podiatr Med Assoc. 2004 May-Jun; 94(3):269-74.

Nawoczenski DA, Ludewig PM. The effect of forefoot and arch posting orthotic designs on first metatarsophalangeal joint kinematics during gait. J Orthop Sports Phys Ther. 2004 Jun;34(6):317-27.

Munera PV, Dominguez G, Palomo IC, Lafuente G: Effects of a rearfoot-controlling orthotic treatment on dorsiflexion of the hallux in feet with abnormal subtalar joint pronation: a preliminary report. J Am Podiatr Med Assoc (2006) July-Aug;96(4):283-9.

Michaud TC, Nawoczenski DA: Then influence of two different types of foot orthoses on first metatarsophlangeal joint kinematics during gait in a single subject. J. Manip Physiolol Ther. 2006 Jan;29(1):60-5.

Scherer PR, Sanders J, Eldredge DE, Duffy SJ, Lee RY: Effect of functional foot orthoses on first metatarsophalangeal joint dorsiflexion in stance and gait. J Am podiatri Assoc. (2006) Now-Dec;96(6):474-81.

After full consideration of the published research, and contrary to the advice of Scherer who advises that functional foot orthoses should be manufactured over casts taken with the first ray plantarflexed, I incorporate first ray cut-outs (i.e., 0% shell width and not just a first metatarsal head cut-out) in every pair of foot orthoses I prescribe, unless my intention is to deliberately restrict 1st MTPJ dorsiflexion.



Ray Anthony

Hi Ray,

What data do we have regarding the effect of introducing a first ray cut-out in an orthosis on the first MTPJ dorsiflexion?

__________________
Who? What? When? Why? Yeah? And? So? What?

"My mission drive is to open up my eyes, 'cause the wicked lies and all the sh!te you say..." http://www.youtube.com/watch?v=V4NW5S1UTPQ

"Science is the antidote to the poison of enthusiasm and superstition."

But then we also get studies like this:

J Orthop Sports Phys Ther. 2004 Jun;34(6):317-27.
The effect of forefoot and arch posting orthotic designs on first metatarsophalangeal joint kinematics during gait.
Nawoczenski DA, Ludewig PM.
Source
Department of Physical Therapy, Ithaca College, University of Rochester Campus, Rochester, NY 14623, USA. dnawoczenski@ithaca.edu
Abstract
STUDY DESIGN:
Repeated-measures analysis of variance.
OBJECTIVE:
To examine the effect of 2 different orthotic posting designs on first metatarsophalangeal (first MTP) joint kinematics during gait.
BACKGROUND:
Common orthotic designs used to control abnormal pronation incorporate the use of a medial post in the forefoot and/or rearfoot locations. Although this design may favorably alter rearfoot and lower-limb kinematics, the incorporation of a forefoot post has been theorized to negatively impact first MTP joint function by limiting hallux dorsiflexion during push off. An alternative design that has been proposed to be more favorable for function of the hallux and first metatarsal is the medial arch support.
METHODS AND MEASURES:
Eighteen subjects with a mean age of 28.2 years (SD, 8.3 years) completed the study. All subjects were judged to have excessive pronation based on a clinical orthopaedic examination. Two different pairs of orthoses were custom molded for each subject. One design incorporated an extrinsic rearfoot and forefoot post and the second design had a high medial longitudinal arch in combination with an extrinsic rearfoot post. The "Flock of Birds" electromagnetic tracking device was used to collect 3-dimensional position and orientation data of 3 body segments (hallux, first metatarsal, and calcaneus) during the stance phase of walking for 3 conditions (no orthosis and each of the 2 different orthotic designs). A repeated-measures analysis of variance was used to assess differences in first MTP joint dorsiflexion at midstance and during the push-off period of gait, as well as metatarsal declination angle changes during relaxed stance. An exploratory regression analysis was used to investigate factors that related to the change in peak dorsiflexion for the orthotic conditions.
RESULTS:
Peak first MTP joint dorsiflexion averaged between 38 degrees and 40 degrees across all conditions. Although slight increases in first MTP joint dorsiflexion values were noted with both types of orthotic designs, these differences were not significant at either phase of the stance cycle (P = .50). The metatarsal declination angle in relaxed stance significantly increased (P = .001) under both orthotic conditions. Considerable individual variability was present. For the rearfoot-forefoot posted orthosis, a change in the declination angle of the first metatarsal during relaxed stance with the orthosis was a significant nonlinear predictor of change in peak dorsiflexion during push off.
CONCLUSIONS:
Foot orthoses that incorporate a medial forefoot post do not have a consistent negative effect of reducing first MTP joint dorsiflexion during walking.


And when we critically examine Scherer's paper in light of other published work such as this:

Weight-Bearing Passive Dorsiflexion of the Hallux in Standing Is Not Related to Hallux Dorsiflexion During Walking
J. Halstead, A.C. Redmond

Study Design: Case control study.

Objective: To explore the validity of the assumptions underpinning the Hubscher maneuver of hallux dorsiflexion in relaxed standing, by comparing the relationship between static and dynamic first metatarsophalangeal (MTP) joint motions in groups differentiated by normal and abnormal clinical test findings.

Background: Limitation of motion at the first MTP joint during gait may be due to either structural or functional factors. Functional hallux limitus (FHL) has been proposed as a term to describe the situation in which the first MTP joint shows no limitation when non-weight bearing, but shows limited dorsiflexion during gait. One clinical test of first MTP joint limitation during standing (the Hubscher maneuver or Jack’s test) has become widely used in physical therapy, orthopedic, and podiatric assessments, supposedly to assess for the presence of hallux limitations during gait. The utility of the test is based on an assumption that restriction during the static maneuver is predictive of functional limitation at this joint during gait. Despite a lack of evidence for the validity of such an assumption, the outcome of the static test is often used to infer risk of overuse injury or as an outcome for functional therapy. This paper examines the validity of the assumptions supporting this widely used static test.

Methods and Measures: First-MTP-joint motion was assessed using an electromagnetic motion tracking system in cases (n = 15) demonstrating clinically limited passive hallux dorsiflexion in relaxed standing, and in 15 controls matched for age and gender and demonstrating a clinically normal Hubscher maneuver. Maximum hallux dorsiflexion was measured with the subject non-weight bearing (seated), during relaxed standing, and during normal walking.

Results: Hallux dorsiflexion was similar in cases and controls when motions were measured non-weight bearing (cases mean ± SD, 55.0° ± 11.0°; controls mean ± SD, 55.0° ± 10.7°), confirming the absence of structural joint change. In relaxed standing, maximum dorsiflexion was 50% less in cases (mean ± SD, 19.0° ± 8.9°) than in the controls (mean ± SD, 39.4° ± 6.1°; P<.001), supporting the initial test outcome and confirming the visual test observation of static functional limitation in the case group. During gait, however, cases (mean ± SD, 36.4° ± 9.1°), and controls (mean ± SD, 36.9° ± 7.9°) demonstrated comparable maximum dorsiflexion (P = .902). There was no significant relationship between static and dynamic first MTP joint motions (r = 0.186, P = .325).

Conclusion: The clinical test of limited passive hallux dorsiflexion in stance is a valid test only of hallux dorsiflexion available during relaxed standing. There is no association between maximum dorsiflexion observed during a static weight-bearing examination and that occurring at the same joint during walking. J Orthop Sports Ther. 2006; 36(8):550-556. doi:10.2519/jospt.2006.2136

It points to the potential flaws in Scherer's study.

__________________
Who? What? When? Why? Yeah? And? So? What?

"My mission drive is to open up my eyes, 'cause the wicked lies and all the sh!te you say..." http://www.youtube.com/watch?v=V4NW5S1UTPQ

"Science is the antidote to the poison of enthusiasm and superstition."

Is one year too short of time span to measure evolution of HV with or without orthotics?

I am using Foot Mobilisation Therapy in combination with orthotics to slow progression in people who have advanced beyond the 12-13 degree range. I've had great results with N=1; her shoes are no longer getting any tighter; they are actually a bit roomier! The 2nd dropped out of treatment.

If only I had the resources to research it properly with a MUCH larger N and recruit patients to the study, rather than just taking care of what walks thru the door...

Once you have been pronated long enough to develop this degree of intermetatarsal angle, the bones/joints of the rearfoot are also poorly aligned; anterior talus, broken cyma line, increased talar declination angle, etc. Stopping them from continuing to slide anterior/plantarly is like trying to roll a cannon ball up hill.

Time shall tell. I try to get pre-FMT x-rays, so one day I will have a larger data set!

Ray makes some very good points and references! Plantarflexing the 1st ray is good only to a point. That point being, how do we keep it plantar flexed when it needs to be!

I find cutouts for the 1st ray with soft backfill, i.e. kinetic wedging, work very well - yes you've heard this before.

Use a digital wedge, ie cluffy wedge, in conjuntoin and the outcomes seem to increase significantly from many differing parameters. Howard talked about this long before Cluffy wedges, but all most people heard were cutouts!

So, ultimately how do we keep a foot with HAV and supinatus at the 1st ray plantar flexed? It takes a lot and often will not work for long.

Also, adding a device to a shoe ultimately decreases the pain free volume within a shoe. An increase in shoe size does not always make a difference. It's a multi-factorial battle.

I agree with Kevin that we often can decrease the pain level, but stopping progression of the overall deformity is rare at best IMO.

Cheers and thanks for the extra references Ray!
Bruce

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Bruce E. Williams, D.P.M.
Breakthrough Podiatry