Hylton B Menz, Polly Q X Lim, Sheree E Hurn, Karen J Mickle, Andrew K Buldt, Matthew P Cotchett, Edward Roddy, Anita E Wluka, Bircan Erbas, Mehak Batra, Shannon E Munteanu
{"title":"拇外翻的非手术治疗:一项随机试验和可行性试验的结果。","authors":"Hylton B Menz, Polly Q X Lim, Sheree E Hurn, Karen J Mickle, Andrew K Buldt, Matthew P Cotchett, Edward Roddy, Anita E Wluka, Bircan Erbas, Mehak Batra, Shannon E Munteanu","doi":"10.1186/s13047-023-00677-1","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p><p><strong>Trial registration: </strong>Australian and New Zealand Clinical Trial Registry (ACTRN12621000645853).</p>","PeriodicalId":49164,"journal":{"name":"Journal of Foot and Ankle Research","volume":"16 1","pages":"78"},"PeriodicalIF":2.5000,"publicationDate":"2023-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10642001/pdf/","citationCount":"0","resultStr":"{\"title\":\"Nonsurgical management of hallux valgus: findings of a randomised pilot and feasibility trial.\",\"authors\":\"Hylton B Menz, Polly Q X Lim, Sheree E Hurn, Karen J Mickle, Andrew K Buldt, Matthew P Cotchett, Edward Roddy, Anita E Wluka, Bircan Erbas, Mehak Batra, Shannon E Munteanu\",\"doi\":\"10.1186/s13047-023-00677-1\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p><p><strong>Trial registration: </strong>Australian and New Zealand Clinical Trial Registry (ACTRN12621000645853).</p>\",\"PeriodicalId\":49164,\"journal\":{\"name\":\"Journal of Foot and Ankle Research\",\"volume\":\"16 1\",\"pages\":\"78\"},\"PeriodicalIF\":2.5000,\"publicationDate\":\"2023-11-13\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10642001/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Foot and Ankle Research\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1186/s13047-023-00677-1\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"ORTHOPEDICS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Foot and Ankle Research","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1186/s13047-023-00677-1","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ORTHOPEDICS","Score":null,"Total":0}
Nonsurgical management of hallux valgus: findings of a randomised pilot and feasibility trial.
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).
期刊介绍：
Journal of Foot and Ankle Research, the official journal of the Australian Podiatry Association and The College of Podiatry (UK), is an open access journal that encompasses all aspects of policy, organisation, delivery and clinical practice related to the assessment, diagnosis, prevention and management of foot and ankle disorders.
Journal of Foot and Ankle Research covers a wide range of clinical subject areas, including diabetology, paediatrics, sports medicine, gerontology and geriatrics, foot surgery, physical therapy, dermatology, wound management, radiology, biomechanics and bioengineering, orthotics and prosthetics, as well the broad areas of epidemiology, policy, organisation and delivery of services related to foot and ankle care.
The journal encourages submissions from all health professionals who manage lower limb conditions, including podiatrists, nurses, physical therapists and physiotherapists, orthopaedists, manual therapists, medical specialists and general medical practitioners, as well as health service researchers concerned with foot and ankle care.
The Australian Podiatry Association and the College of Podiatry (UK) have reserve funds to cover the article-processing charge for manuscripts submitted by its members. Society members can email the appropriate contact at Australian Podiatry Association or The College of Podiatry to obtain the corresponding code to enter on submission.
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