Dynamic Splinting for Postoperative Hallux Limitus: A Randomized, Controlled Trial
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Mathew M. John, Stanley Kalish, Stephen V. Perns and Buck Willis
JAPMA July/August 2011 vol. 101 no. 4 285-288
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Lets play a game:
Who can see why the data does not support the conclusion?
Who trusts the results?
Why have JAPMA done this to us yet again? -
I'm not too good at these games, cause I though stats was too boring and irrelevant at uni. Wishing I listened now though!
Anyway, I'll try questions 2- Who trusts the results? Not me! It's associated with Dynasplint Systems Inc, which sounds like a company making the splints. I know that doesn't automatically make the research invalid, but it might. -
Like many papers in JAPMA recently this one falls woefully short of the minimum reporting standard that should be expected of a clinical trial (see this eg on Neuromas and shockwave which actually showed the opposite of what they claimed they found; and this one from one of the same authors above: Plantar Fasciopathy Treated with Dynamic Splinting). The accepted standard for the reporting of clinical trials is the CONSORT statement, which JAPMA even reproduced previously.
Anyone reading this paper and the CONSORT statement can see how far short it falls in its reporting.
In addition there are so many other issues, that its next to impossible to believe the results:
Lets start:
- no details on how the randomization was done
- if it was a proper randomization the probability of getting exactly 25 in each group (which they did) is low, but can still happen
- no info on how they measured the ROM, let alone anything on if the measurements were reliable (and we all know about how unreliable these type of measurements are); for eg, how many people did the measurements to ensure reliability; no data on the intertester and intratetser reliability of the measurements. Are you prepared to trust the measurements without this data?
- no stats test to confirm the baseline characteristics between the experimental and control group were the same (look at the graph and there seems to be big differences in the baseline characteristics of ROM!!!!)
- the actual means and SD's of the ranges before and after in each group are not even reported!!!!! ... we have no idea what they are (you could guesstimate it from the graph!)
-an ANOVA was done, but I can't see why you would do that when there are only two groups to compare; they need to justify that decision (stating is was done by a "biostatstics professor" is not good enough)
-even if ANOVA was suitable, it should had been a CANOVA to account for the baseline differences between the two groups
- "two people withdraw" - their data should still have been included in the analysis - 'intention to treat' is the gold standard for analysis in clinical trials.
- they claim a "mean improvement of 250% in ROM" - looking at the graph, it appears the experimental group went from about 16 degrees to 44 degrees and the control group when from about 21 degrees to 35 degrees (notice the baseline differences they did not account for in the analysis). While there may have been a 250% improvement in the experimental group, the endpoint differences between the groups of 35 degrees and 44 degrees, is not that great and given the baseline differences and no formation given on the SD's.....what do you think of that?
Anyone want to trust the results? -
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Short term results of dynamic splinting for hallux valgus – a prospective randomized study
ChristianPlaassaAnnikaKarchbArminKochbVivienWiederhoeftaSarahEttingeraLeifClaassenaKiriakosDaniilidisacDaiweiYaoaChristinaStukenborg-Colsmana
Foot and Ankle Surgery; 1 January 2019
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A comparison of the hallux valgus angle, range of motion, and patient satisfaction after use of dynamic and static orthoses
NasrinMoulodiMojtabaKamyabMaedeFarzadi
The Foot; 25 June 2019
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The effect of combined exercise-bandage protocol on hallux valgus angle in women with hallux valgus deformity
Biravar Khandani et al
University of Tehran
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Hallux valgus orthosis characteristics and effectiveness: a systematic review with meta-analysis
Mei-Ying Kwan et al
BMJ Open 2021;11:e047273. doi: 10.1136/bmjopen-2020-047273
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The immediate effects of hallux valgus orthoses: A comparison of orthosis designs
Mei-YingKwan et al
Gait & PostureVolume 90, October 2021, Pages 283-288
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The Evaluation of Orthotics in Reducing Hallux Valgus Angle in Patients with Hallux Valgus over a Twelve-Month Treatment
Guoli Li et al
Int J Environ Res Public Health. 2022 Oct 1;19(19):12531
Background: Hallux valgus (HV) is one of the most common forefoot deformities among females, and its prevalence increases with age. This study aims to evaluate the effectiveness of three different types of orthotics on the reduction in hallux valgus angle (HVA) for patients with mild and moderate hallux valgus deformities.
Methods: Twenty-six patients (42 feet) with mild or moderate HV participated in the treatment with three types of orthotics in the current study. Patients were divided into three groups depending on their HV severities and the consideration of different function of the orthotics. Orthotic Type 1 is a biomechanical style orthotic applied to moderated HV in Group 1. Orthotic Type 2 is a wrap style orthotic used on mild and moderate HV with two sub-groups: mild HV in Group 2A and moderate HV in Group 2B. Orthotic Type 3 is a gel style orthotic for mild HV. Patients were required to wear the orthotics for between 6 and 8 h per night over a period of 12 months. The HVA was measured every 3 weeks using a newly designed Measuring Block. A paired t-test was used to compare the differences between initial and final HVA at different stages of HVA treatment with orthotics.
Results: After the 12-month treatment, for moderate HV patients treated with the Orthotic Type 1, their HVA reduced by 5.05° (95% CI 1.37, 8.73), (p < 0.05). For moderate HV patients treated with the Orthotic Type 2, their HVA reduced by 1.2° (95% CI -0.71, 3.11) (p > 0.05). For mild HV patients treated with the Orthotic Type 2, their HVA reduced by 2.44° (95% CI 1.39, 3.49) (p < 0.05). For mild HV patients treated with the Orthotic Type 3, their HVA reduced by 3.08° (95% CI -0.68, 6.83) (p > 0.05).
Conclusions: Orthotic Type 1 showed a consistent significance in reduction in the HVA during the 12-month treatment, so it could be recommended for treating moderate HV. Orthotic Type 2 reduced the HVA, but it did not show a consistent significance in reduction in the HVA for mild and moderate HV. Orthotic Type 3 reduced the HVA, but it showed a volatile trend during 12 months without significant differences.Click to expand... -
The Evaluation of Orthotics in Reducing
Hallux Valgus Angle in Patients with
Hallux Valgus over a Twelve-Month
Treatment
Guoli Li et al
Source
Background: Hallux valgus (HV) is one of the most common
forefoot deformities among females, and its prevalence increases
with age. This study aims to evaluate the effectiveness of three
different types of orthotics on the reduction in hallux valgus
angle (HVA) for patients with mild and moderate hallux valgus
deformities.
Methods: Twenty-six patients (42 feet) with mild or moderate
HV participated in the treatment with three types of orthotics in
the current study. Patients were divided into three groups
depending on their HV severities and the consideration of
different function of the orthotics. Orthotic Type 1 is a
biomechanical style orthotic applied to moderated HV in Group
1. Orthotic Type 2 is a wrap style orthotic used on mild and
moderate HV with two sub-groups: mild HV in Group 2A and
moderate HV in Group 2B. Orthotic Type 3 is a gel style orthotic
for mild HV. Patients were required to wear the orthotics for
between 6 and 8 hours per night over a period of 12 months. The
HVA was measured every 3 weeks using a newly designed
Measuring Block. A paired t-test was used to compare the
differences between initial and final HVA at different stages of
HVA treatment with orthotics.
Results: After the 12-month treatment, for moderate HV patients
treated with the Orthotic Type 1, their HVA reduced by 5.05°
(95% CI 1.37, 8.73), (p < 0.05). For moderate HV patients
treated with the Orthotic Type 2, their HVA reduced by 1.2°
(95% CI −0.71, 3.11) (p > 0.05). For mild HV patients treated
with the Orthotic Type 2, their HVA reduced by 2.44° (95% CI
1.39, 3.49) (p < 0.05). For mild HV patients treated with the
Orthotic Type 3, their HVA reduced by 3.08° (95% CI −0.68,
6.83) (p > 0.05).
Conclusions: Orthotic Type 1 showed a consistent significance
in reduction in the HVA during the 12-month treatment, so it
could be recommended for treating moderate HV. Orthotic Type
2 reduced the HVA, but it did not show a consistent significance
in reduction in the HVA for mild and moderate HV. Orthotic
Type 3 reduced the HVA, but it showed a volatile trend during
12 months without significant differencesClick to expand... -
Ergonomic Design of Hallux Valgus Orthosis
Developed Using 3D Scanning and 3D Printing
Mei-Ying Kwan et al
PRSC 2023
—Hallux valgus (HV) is a common progressive foot
deformity affecting nearly one in four adults worldwide and is
more common among narrow-toed shoe wearers and ballerinas.
It is characterized by a deviation of the first ray angle, which
can cause foot pain, swelling, blisters, and poor balance. HV
orthoses can be used as a conservative treatment to prevent
further deterioration of the HV angle. However, the bulky
design of the current orthoses made of rigid materials causes
wear discomfort and fit problem to footwear for daily activities,
hence reducing treatment compliance. In this study, customized
3D geometric and design elements were systematically analyzed.
A functional sock-like HV orthosis was developed by using
three-dimensional (3D) foot scanning and 3D printing
technology with reference to the opinions of prosthetists and
orthotists. Through wear trials, personalized orthosis designs,
material choice and prototypes with optimal fit can be efficiently
determined. Most importantly, it results in effective HV angle
correction with preserved wearing comfort for improved
treatment compliance.Click to expand... -
Effects of Foot-Toe Orthoses on Moment and Range of Motion of Knee Joint in Individuals with Hallux Valgus
Yongwook Kim
11 May 2023
Although various types of hallux valgus (HV) orthoses have been used to manage hallux valgus deformity, few previous studies have determined the biomechanical effects of applying a foot-toe orthosis as a therapeutic intervention for HV deformity on the kinetics and kinematics of the knee joint. Biomechanical variables were collected from 24 patients with HV. A three-dimensional motion capture system and force platforms were used to analyze the kinetic and kinematic variables in HV orthosis conditions during gait. To determine the biomechanical effect of each orthosis for HV on knee kinetic and kinematic values, repeated-measures ANOVA was used. The knee adduction moment was significantly decreased under a hard plastic orthosis (HPO) condition compared to that under a without foot-toe orthosis (WTO) condition (p = 0.004). There was a significant decrease in maximal external rotation of the knee joint in HPO than in WTO at the stance phase during gait (p = 0.021). All of the kinetic and kinematic data showed no significant differences between WTO and soft silicone orthosis conditions (p > 0.05). This study indicates that a stronger foot-toe orthosis, such as HPO, to correct HV deformity has a positive effect on the moment and joint motion occurring in the knee joint during walking. In particular, the application of this type of HV orthosis can reduce knee adduction moments associated with the development and progression of knee OA.Click to expand... -
Dynamic-passive correction of hallux valgus and associated static foot deformities
Jacek Dygut et al
Acta Bioeng Biomech. 2023;25(1):65-77.
Purpose: The aim of this paper was the application of a new dynamic-passive method of treatment in correction of hallux valgus and coexisting static deformities of the foot (transverse-plane and plano-valgus foot).
Methods: The study involved 50 patients; 26 with full big toe correction after the passive correction grip (group I) and 24 with big toe correction requiring additional passive abduction (group II). The patients regularly performed exercises using the designed device according to the planned schedule. The progress of the correction was assessed by a medical examination and additional tests.
Results: The cross-sectional area [cm2 ] of the abductor hallucis muscle in three-time points among I and II groups of patients with the hallux valgus was measured based on MRI images. The STIR examination showed, among others, the abductor hallucis muscle edema after exercises with the DPc device were carried out. It evidences that exercises with the new device activate the muscle. Alignment of the big toes of both feet in groups I and II were obtained with a statistically significant result ( p < 0.05). The percentage progression of correction for HV and I/II IM was calculated.
Conclusions: Based on the new correction approach the alignment of the big toe phalanges and the remaining toes was obtained. The passive setup of the tendons with their distal inserts at the level of the big toe phalanges to the correct path of their course with the withdrawal of articular subluxations was obtained. Simultaneously, the big toe's passive correction was dynamically consolidated through a specially selected set of exercises.Click to expand... -
An Observational Longitudinal Study Investigating the Effectiveness of Adjustable Splint on Individuals with Hallux Valgus
Navaporn Chadchavalpanichaya et al
Source
Objectives: To explore the effectiveness of an adjustable splint to decrease hallux valgus angle and pain at the first metatarsophalangeal joint. In addition, to discover complications and participants’ satisfaction Study design: Prospective cohort analytical study design Setting: Foot Clinic, Department of Rehabilitation Medicine, Faculty of Medicine Siriraj Hospital, Bangkok, Thailand Subjects: Thirty-eight patients with hallux valgus deformity at moderate to severe degrees (hallux valgus angle 30°- 50°) were recruited from March to May 2021. Methods: The participants were asked to use an adjustable splint for 6 hours daily for 12 months and continue their current treatment regimen. They were also asked to record the duration of wearing the splint and complications in a logbook every week. Hallux valgus angle measured from radiography and pain numeric rating scale (pain NRS) were evaluated at baseline, 6 months, and 12 months after getting the splint. Results: Thirty-two participants returned for follow-up at the end of the study. Per protocol and intention to treat, analyses showed a decreased hallux valgus angle and pain at the first metatarsophalangeal joint with a statistically significant difference (p = 0.001). The satisfaction scores with the adjustable splint were high in every domain. No participant had serious complications. The common complication was splint slip (33.3%). Conclusions: Wearing an adjustable splint for 12 months in patients with moderate to severe degrees of hallux valgus could decrease hallux valgus angle and pain at the first metatarsophalangeal joint without serious complications.Click to expand...
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