Nonsurgical management of hallux valgus: findings of a randomised pilot and feasibility trial Article Swipe
Hylton B. Menz
,
Polly Q. X. Lim
,
Sheree E. Hurn
,
Karen J. Mickle
,
Andrew K. Buldt
,
Matthew Cotchett
,
Edward Roddy
,
Anita E. Wluka
,
Bircan Erbas
,
Mehak Batra
,
Shannon E. Munteanu
·
YOU?
·
· 2023
· Open Access
·
· DOI: https://doi.org/10.21203/rs.3.rs-3383358/v1
YOU?
·
· 2023
· Open Access
·
· DOI: https://doi.org/10.21203/rs.3.rs-3383358/v1
Background Hallux valgus is a common and disabling condition. This randomised pilot and feasibility trial aimed to determine the feasibility of conducting a parallel group randomised trial to evaluate the effectiveness of a nonsurgical intervention for reducing pain associated with hallux valgus. Methods Twenty-eight community-dwelling women with painful hallux valgus were randomised to receive either a multifaceted, nonsurgical intervention (footwear, foot orthoses, foot exercises, advice, and self-management) or usual care (advice and self-management alone). Outcome measures were obtained at baseline, 4, 8 and 12 weeks. The primary outcome was feasibility, evaluated according to demand (recruitment rate and conversion rate), acceptability, adherence, adverse events, and retention rate. Limited efficacy testing was conducted on secondary outcome measures including foot pain, foot muscle strength, general health-related quality of life, use of cointerventions, and participants’ perception of overall treatment effect. Results Between July 8, 2021, and April 22, 2022, we recruited and tested 28 participants (aged 44 to 80 years, mean 60.7, standard deviation 10.7). This period encompassed two COVID-related stay-at-home orders (July 16 to July 27, and August 5 to October 21, 2021). The predetermined feasibility thresholds were met for retention rate, foot pain, mental health-related quality of life, and use of cointerventions, partly met for acceptability, adverse events, and muscle strength, and not met for demand (recruitment rate or conversion rate), adherence, physical health-related quality of life and perception of overall treatment effect. Conclusion In its current form, a randomised trial of footwear, foot orthoses, foot exercises, advice and self-management for relieving pain associated with hallux valgus is not feasible, particularly due to the low adherence with the intervention. However, it is difficult to determine whether the trial would be feasible under different circumstances, particularly due to COVID-19 stay-at-home orders. Future trials will need to consider improving the aesthetics of the footwear and making the exercise program less burdensome. Trial registration Australian and New Zealand Clinical Trial Registry (ACTRN12621000645853).
Related Topics
Concepts
Metadata
- Type
- preprint
- Language
- en
- Landing Page
- https://doi.org/10.21203/rs.3.rs-3383358/v1
- https://www.researchsquare.com/article/rs-3383358/latest.pdf
- OA Status
- gold
- Cited By
- 1
- References
- 46
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W4387298071
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W4387298071Canonical identifier for this work in OpenAlex
- DOI
-
https://doi.org/10.21203/rs.3.rs-3383358/v1Digital Object Identifier
- Title
-
Nonsurgical management of hallux valgus: findings of a randomised pilot and feasibility trialWork title
- Type
-
preprintOpenAlex work type
- Language
-
enPrimary language
- Publication year
-
2023Year of publication
- Publication date
-
2023-10-03Full publication date if available
- Authors
-
Hylton B. Menz, Polly Q. X. Lim, Sheree E. Hurn, Karen J. Mickle, Andrew K. Buldt, Matthew Cotchett, Edward Roddy, Anita E. Wluka, Bircan Erbas, Mehak Batra, Shannon E. MunteanuList of authors in order
- Landing page
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https://doi.org/10.21203/rs.3.rs-3383358/v1Publisher landing page
- PDF URL
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https://www.researchsquare.com/article/rs-3383358/latest.pdfDirect link to full text PDF
- Open access
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YesWhether a free full text is available
- OA status
-
goldOpen access status per OpenAlex
- OA URL
-
https://www.researchsquare.com/article/rs-3383358/latest.pdfDirect OA link when available
- Concepts
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Pilot trial, Valgus, Medicine, Physical therapy, Randomized controlled trial, Physical medicine and rehabilitation, SurgeryTop concepts (fields/topics) attached by OpenAlex
- Cited by
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1Total citation count in OpenAlex
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2025: 1Per-year citation counts (last 5 years)
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46Number of works referenced by this work
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10Other works algorithmically related by OpenAlex
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| publication_date | 2023-10-03 |
| publication_year | 2023 |
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