Research Evidence

Proprietary studies, NHS materials, military-study analysis, third-party literature, and conventional footcare critique.

Research Evidence

Proprietary Studies

Key rule: Present as functional/physiological evidence (Tier 2), not RCT-level clinical proof. These measure what the foot does differently — not treatment outcome studies.

Previously documented studies (from Monograph — source files not yet in this folder):

Documents now in this folder:

2018 Study 6 Biofeedback Insole Usage Creates Morphological Changes to Foot Structure.pdf

2018 Study 7 Consumers Embrace New Insole Based on Bio-Feedback and Foot Strengthening.pdf

2018 Study 8 Biofeedback Insole Usage Produces Improved Gait Kinematics.pdf

2018 Study 12 Plantar Surface Area of the Foot Reduced Through Use of Biofeedback Insole.pdf

biomechanics mag.docx ← THE PUBLISHED PEER-REVIEWED ARTICLE — READ THIS

Noraxon USA | Motor Patterns and Pathologies – Installment #4.pdf ← PRIMARY VERSION

Noraxen EMG data.pdf — duplicate of above (plain text version, different archive source)

Motor Patterns & Pathologies – Part 4... BioPerformance Texas.pdf — same article republished on third-party site; includes Lemke's extended account of his own knee injury (anticipated surgical intervention) resolving within 5 weeks of BFS use

biomechanics mag.pdf

TEGH Pain study.doc ← FLAGSHIP CLINICAL STUDY — HIGH PRIORITY FOR CONTENT

BFS Monograph copy.pdf

Schema entries: See MASTER-SCHEMA.md — F-Scan Study, Motion Capture Study, sEMG Study, Structural Strength Comparison, Huddersfield Study

NHS Study

Contents: Neil Frame DPodM MChS study (2012–2015, Stockport NHS Foundation Trust), NHS Innovation England publication (June 2016), 999/1000 patient preference finding, Terence David Moore patient testimony, data disappearance sequence.

Source materials to add here:

Key rule: Use verbatim formats from biopods-nhs-content-versions.docx only. Do not paraphrase the study description or findings. Present data disappearance as documented fact; draw no conclusions.

Cross-reference — researcher credibility:
See 06-authority-assets/nhs-recognition/neil-frame-physio-first-conference-nov-2014.pdf — a third-party published record (PhysioPod UK, archived May 2015) of Neil Frame presenting Barefoot Science to physiotherapy professionals at the Scottish Physio First Conference in November 2014, during the study period. Independent corroboration of his credentials (MChS SRCh DPodM, WalkinCentre, Cheshire) and active clinical advocacy for Barefoot Science before the NHS publication.

Schema entries: See MASTER-SCHEMA.md — NHS Clinical Study

Sherman et al. Military Study

Contents: US Army prospective study, 1,132 male recruits, Spenco Polysorb arch-supporting insoles, findings of increased injury rate in insole group (38%) vs control (29%).

Source materials to add here:

Key finding: Level 1 evidence that conventional arch-supporting insoles cause harm under load. Insert group had higher lower-limb injury rate than the group wearing plain, unaltered footwear. Authors stated data strongly suggested passive inserts may have actively caused lower extremity injuries.

Schema entries: See MASTER-SCHEMA.md — Sherman et al. Military Study

Third-Party Literature

Purpose: Published research and authoritative writing supporting the Biopods scientific framework. Add new studies here after every blog post. Log each addition in 00-schema/NEW-CONTENT-LOG.md.

Documents now in this folder:

shulman-1949-survey-unshod-feet-china-india-5128-subjects.pdf ← HIGH VALUE

rossi-why-shoes-make-normal-gait-impossible.pdf

rossi-footwear-primary-cause-foot-disorders.pdf

rossi-children-footwear-launching-site-adult-foot-ills.pdf

rossi-fashion-and-foot-deformation.pdf

wikler-1961-take-off-your-shoes-and-walk.htm

malka-osteoporosis-bone-remodeling-wolff-law.htm

polakoff-repetitive-stress-injuries.htm

Previously documented studies (PDFs not yet filed):

Study Finding Relevance
McKeon et al. (2015) — BJSM — "The Foot Core System" Intrinsic foot muscles act like lumbo-pelvic core; conventional shoes cause foot core shutdown Foot strengthening framework
Curtis et al. (2021) — Scientific Reports 57% increase in intrinsic foot flexor strength with minimal footwear over 6 months Davis's Law / Wolff's Law
Cheung et al. (2016/2017) 11.9% increase in forefoot muscle volume via MRI after transition from cushioned shoes Muscle recruitment restored when support removed
Barres et al. (2012) — Cell Metabolism Single exercise session → 10% less PGC-1α methylation → increased gene expression at 3 hours Epigenetic plasticity
Lindholm et al. (2018) — Nature Scientific Reports Lifelong exercisers show lasting promoter hypomethylation in metabolic/contractile/oxidative genes Epigenetic plasticity
Ornish (2008) — PubMed 90 days lifestyle change → 500+ genes altered; no pharmacological intervention Epigenetic plasticity

Action needed: Source and file PDFs for the above studies.

Additional reference to source (cited in Biomechanics Oct 2001 article):

Conventional Critique

Purpose: Third-party published evidence demonstrating the failure of conventional orthotics and the low quality of podiatric research. The foundation of the Quality of Science Argument — the most important strategic content for Barefootscience.ai.

The orthotic x-ray finding (verbatim from Monograph):
"In every instance, the orthotics had little or no effect on the relative alignment or structural integrity of the interlocking bones, specifically in the midfoot… The only appreciable change observed in the relative alignment was strictly a result of the increased heel height… In all instances, the bones of the foot remained 'unlocked,' and functionally unstable."

Documents in this folder:

turlik-kushner-2000-levels-of-evidence-podiatric-journals.pdf ← CORNERSTONE DOCUMENT

Verbatim abstract finding:
"The authors reviewed 322 articles in podiatric medical journals to determine their level of evidence. Only 1% of the articles reviewed were randomized controlled trials. The authors concluded that if the podiatric medical profession wishes to become a participant in evidence-based medicine, greater emphasis must be placed on studies that assess hypotheses."

Verbatim Discussion finding:
"Of the published articles reviewed in this study, 1% presented what would be considered level 1 evidence. A large majority of the published articles reviewed dealt with generating, rather than testing, hypotheses."

Exact breakdown from Table 2:

Type of Article Total %
Randomized controlled trial 4 1%
Cohort study 7 2%
Case-control study 15 5%
Case series 103 32%
Case report 116 36%
Literature review 39 12%
Animal/cadaver study 20 6%
Unclassified 18 6%
Total 322 100%

Significance: The entire conventional podiatric evidence base is built predominantly on uncontrolled case reports and case series — the weakest evidence categories (levels 4–5). This is the foundational citation for the Quality of Science Argument on Barefootscience.ai.

Use: When conventional practitioners invoke "the evidence," this paper — published in the profession's own journal, by its own academics — is the response. Cite the verbatim abstract finding above; do not paraphrase.

joseph-2000-JAPMA-editor-response-turlik-kushner.pdf ← FULL TEXT HELD — READ THIS FIRST

This document is the most rhetorically powerful in the entire folder. The Editor of the journal in which the Turlik & Kushner paper was published used his editorial to confirm the findings, explain why the problem is structural, and state he sees no significant change coming. This is the establishment indicting itself.

Key verbatim quotes:

On how long this has been known:
"This has been a refrain of critics of the podiatric medical literature for as long as anyone can remember. It is a frequent topic of discussion on Internet listserves and at continuing medical education conferences. Anyone who has ever served on an editorial board of one of the profession's journals has heard derogatory comments about the abundance of case reports."

On the structural cause:
"The problem rests more in the overall structure of the profession than in any particular component."
"In podiatric medicine we lack a 'critical mass' of trained researcher-authors. If one were to combine all of the faculties (full and part time) of all of the colleges of podiatric medicine, the result would be fewer people than in an internal-medicine department at a single medical school."

On the outlook:
"There is no easy solution, and I see no significant change coming."

On his own agreement with Turlik & Kushner:
"I agree with Drs. Turlik and Kushner that, if we wish to participate in the world of evidence-based medicine, our profession must become more active in the performance and publication of significant original research."

Strategic significance: This editorial transforms the Turlik & Kushner finding from a one-off academic critique into a confirmed, longstanding, structural problem — acknowledged by the profession's own journal editor in the same breath as the paper was published. The phrase "I see no significant change coming" is particularly usable: it means the 1% figure is not a temporary state being actively corrected but a chronic structural condition of the field.

Use: Open or close the quality-of-science argument with this editorial. It provides the human voice of the establishment confirming what the data shows — and admitting the profession cannot fix it. Do not paraphrase; use verbatim quotes as above.

paci-2011-evidence-levels-physical-rehabilitation-medicine-journals.pdf

Verbatim abstract findings:
"A total of 5,451 articles were included in this study, of which 636 (11.7%) were randomized controlled trials. Articles published with the highest frequency were those classified as Level III (n=2,424, 44.5%), whereas 'systematic reviews' were the least frequent (n=164, 3.0%). No increase in articles with a high level of evidence was found in the selected journals over the period of study."

Verbatim conclusion:
"The distribution of different types of article in Physical and Rehabilitation Medicine journals is similar to that in other disciplines. There has been no increase in articles with a high level of evidence published in the selected journals over the time-period analysed."

Exact breakdown (Table II):

Level n % Type
Level I 636 11.7% Randomized controlled trials
Level II 269 4.9% Controlled clinical trials
Level III 2,424 44.5% Cohort, observational, descriptive
Level IV 478 8.8% Case report/series (<10 subjects)
Systematic reviews 164 3.0% Meta-analysis, systematic reviews
Non-systematic reviews 307 5.6% Narrative reviews
Validation studies 847 15.5% —
Others 326 6.0% —
Total 5,451

Strategic significance for the Quality of Science Argument:
This paper extends the evidence quality problem beyond podiatry to the entire Physical and Rehabilitation Medicine field — the broader set of disciplines (physiotherapy, rehabilitation medicine, sports medicine) that treat the conditions Biopods addresses. Even in this broader field, only 11.7% of articles are RCTs — and the situation was not improving over time. Podiatry (1% RCTs, per Turlik & Kushner 2000) is dramatically worse than even this low baseline.

The paper also cites similar findings in sports medicine (Bleakley & MacAuley 2002, Br J Sports Med) and orthopaedics (Obremskey et al. 2005, J Bone Joint Surg) — suggesting this is a systemic failure across every discipline relevant to foot and musculoskeletal health.

Use: Companion citation to Turlik & Kushner. Together they establish that the low evidence quality is not a podiatry-specific anomaly — it is the norm across all relevant fields. Biopods' evidence (NHS study, TEGH clinical study, F-scan data) sits at a higher standard than the typical output of these disciplines.

landorf-2015-methodological-quality-RCTs-JAPMA-1999-2013.pdf ← FULL TEXT HELD

Verbatim abstract findings:
"A total of 1,143 articles were published in JAPMA between January 1999 and December 2013. Of these, 44 articles were reports of randomized trials. Although the number of randomized trials published each year increased, there was only minimal improvement in their methodological quality (mean rate of improvement = 0.01 points per year). The methodological quality of the trials studied was typically moderate, with a mean ± SD PEDro score of 5.1 ± 1.5. Although there were a few high-quality randomized trials published in the journal, most (84.1%) scored between 3 and 6."

Verbatim conclusion:
"Although there has been an increase in the number of randomized trials published in JAPMA, there is substantial opportunity for improvement in the methodological quality of trials published in the journal."

Key data points (exact):

Additional citations this paper provides (worth sourcing):

Strategic significance — the complete narrative this paper establishes:
This paper closes the loop on the evidence quality argument across 15 years. The progression:

  1. Turlik & Kushner (2000): Only 1% of podiatric articles are RCTs
  2. Landorf et al. (2015): A decade later, still only 3.8% are RCTs — and even those RCTs are typically only moderate quality (5.1/10)
  3. Quality improving at 0.01 points per year — the field is essentially static
  4. Only 1 trial in 15 years was registered with a clinical trial registry

This is not a historical critique — it is current as of 2013 data, published 2015. The conventional podiatric evidence base remains structurally weak, and what little exists is itself of questionable quality.

Use: This is the definitive citation for the "even the RCTs aren't good" layer of the quality-of-science argument. Use after establishing the 1% baseline (Turlik & Kushner) to show that even the trend toward more RCTs hasn't produced trustworthy findings.

barske-baumhauer-2012-quality-research-foot-ankle-publications ← ABSTRACT ONLY (paywalled)

Verbatim abstract results:
"A total of 245 articles were published, 128 were excluded based on study design, leaving 117 clinical research articles. Seven (6%) were Level I, 14 (12%) Level II, 18 (15%) Level III, and 78 (67%) Level IV. The orthopedic journals published 78 studies on foot and ankle topics. Of the podiatric journals, the Journal of the American Podiatric Medical Association (JAPMA) published 12 clinical studies and the Journal of Foot and Ankle Surgery (JFAS) published 27, 21 (78%) of which were Level IV studies. When the quality of research was examined, few therapeutic studies used validated outcome measures and only 38 of 96 (40%) gathered data prospectively. Thirty (31%) studies used a comparison group."

Verbatim abstract conclusion:
"Foot & Ankle International (FAI) published higher quality studies with a higher LOE as compared to podiatry journals. Regardless of the journal, MDs produced the majority of published clinical foot and ankle research. Although improvements have been made in the quality of some clinical research, this study highlights the need for continued improvement in methodology within foot and ankle literature."

Key data points:

Strategic significance: This is a 2012 update confirming the same structural evidence weakness identified by Turlik & Kushner in 2000 — and it focuses specifically on foot and ankle research, the most directly relevant field. Published in the AOFAS's own journal, making this the establishment critiquing itself. The JFAS finding (78% Level IV) is particularly striking. Note: previously mis-catalogued in knowledge base summaries as "Barres et al. 2012."

Action needed: Obtain full PDF if possible (institutional access or author request via ResearchGate).

mattila-2011-orthotics-rct-no-benefit-228-subjects.pdf

withnall-2006-shock-absorbing-insoles-rct-no-benefit-recruits.pdf

landorf-2006-foot-orthoses-plantar-fasciitis-rct-no-long-term-benefit.pdf

aaos-frey-1996-otc-insoles-more-effective-than-custom-orthotics.pdf

Shock absorbing insoles and lower limb injury.webarchive

ostlie-stpeter-2010-evidence-based-pediatric-surgery ← ABSTRACT ONLY (screenshot)

Verbatim results:
"The search criteria produced 56 manuscripts, of which 51 described appropriate randomization techniques. A definitive trial design with a sample size calculation was utilized in only 19 studies (34%). A statistically significant difference between treatment arms was identified in 29 of the 56 (52%) trials. There were 26 different journals of publication… The combined total publications from January 1999 through December 2009 for the 26 journals these randomized trials represent 0.04% of all publications."

Verbatim conclusion:
"The current state of evidence-based surgery in pediatric surgery has remained stable in the first decade of the 21st century. Randomized controlled trials represent less than 0.05% of all publications involving pediatric surgery."

Strategic significance: Contextual / broadening reference. This paper is not directly about podiatry or foot health, but establishes that the evidence quality problem is pervasive across medicine — with RCTs representing less than 0.05% of all pediatric surgery publications. Podiatry at 1% (Turlik & Kushner) looks relatively better only by comparison to this extreme. The broader point for content: conventional medicine, including surgery, routinely makes treatment decisions without RCT-level evidence — foot care is not an outlier, it is a symptom of a wider structural problem.

Usage note: Use as contextual support, not a primary citation. The podiatric-specific papers (Turlik & Kushner, Landorf et al., Barske & Baumhauer) are the primary citations for the cornerstone argument. This paper supports the "this isn't just podiatry" framing if needed, but should not be the lead.

turlik-kushner-stock-2003-validity-RCTs-podiatric-journals.pdf ← FULL TEXT HELD

Verbatim abstract finding:
"The results of the study indicate that randomized controlled trials published in podiatric medical journals are less credible than those published in a mainstream medical journal."

Verbatim conclusion:
"The quantity of RCTs published by podiatric physicians in podiatric medical journals is limited, and the quality is lower than in mainstream medicine. It is important for podiatric physicians to produce pragmatic, valid, and definitive RCTs to demonstrate the effectiveness and safety of therapeutic interventions unique to podiatric medicine."

Core result (exact):

Category-by-category breakdown (Table 2 — exact figures):

Validation Question Podiatric (Yes) Podiatric (No) JAMA (Yes) JAMA (No)
1. Randomization explained 2 7 5 4
2. Concealment allocation explained 0 9 3 6
3. Groups comparable at baseline 5 4 9 0
4. All patients accounted for 4 5 9 0
5. Assessors of outcomes blinded 2 7 8 1
6. Outcome instrument validated 4 5 9 0
7. Sample size calculated beforehand 1 8 8 1
8. Statistical analysis appropriate 7 2 9 0
9. 95% CI calculated 1 8 7 2
Total 26 55 67 14

The most damning individual findings:

Additional context from the paper:

Strategic significance — this paper closes the quantity/quality loop:
The argument now has two layers from the same research team, in the same journal:

  1. Turlik & Kushner (2000): The evidence base is 99% case reports and series — only 1% are RCTs
  2. Turlik, Kushner & Stock (2003): The 1% that are RCTs don't meet basic methodological standards — only 32% satisfactory vs JAMA's 83%, P < .001, with zero acceptable on the single most critical validity measure

The profession cannot escape this with "we just need more RCTs" — the RCTs they produce are themselves of insufficient quality to support clinical decision-making.

Use: Deploy after establishing the 1% baseline. The sequence is: not enough RCTs (2000) → and the ones that exist aren't credible (2003) → and 15 years later it hasn't meaningfully improved (Landorf et al. 2015). Three papers, same journal, same authors on two of them — the profession documenting its own evidentiary failure across 15 years.

menz-2001-publication-patterns-podiatric-faculty-JAPMA.pdf ← CONTEXTUAL/SUPPORTING

Key findings (exact):

Why it matters for the Quality of Science Argument:
This paper provides the structural explanation for what Joseph (2000) diagnosed as a "lack of critical mass of trained researcher-authors." The data here gives that diagnosis empirical substance: a third of academic faculty had never published, and average output was half the rate of comparable medical school faculty. The profession is not generating the researcher pipeline needed to produce high-quality evidence.

Acknowledgment note: Menz thanks "Karl B. Landorf, DipAppSc(Pod), GradDipEd" for manuscript assistance — Landorf is the lead author of the 2015 RCT quality paper already in this folder. Both Menz and Landorf were early in their careers at this point; by 2015 they were the profession's leading evidence-quality researchers, still documenting the same structural problem.

Use: Background/contextual reference. Use to support the structural explanation layer of the quality-of-science argument — the Joseph editorial identifies the problem, this paper quantifies the underlying cause. Not a primary citation for the cornerstone article, but useful if the piece goes deep on why the evidence is thin.

Previously documented (not yet filed as separate documents):

Schema entries: See MASTER-SCHEMA.md — Orthotic X-Ray Study, Turlik & Kushner, Habitually Shod Baseline Error, Quality of Science Argument

Educational content only. This page is not a diagnosis, prescription, or substitute for care from a qualified clinician.