Efficacy of Corrective Rubber Insoles in Healthcare Professionals With Foot Overpronation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Medially wedged ortheses.
- Who it may be relevant to
- Registry conditions: Hyperpronation, Overpronation, Pes Planus. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of the Efficacy of Corrective Rubber Insoles in a Population of Healthcare Professionals With Foot Overpronation
Overview
Foot hyperpronation is a common postural condition that can lead to pain, deformities (such as hallux valgus), and muscular issues. This problem is especially relevant among adults who spend long hours standing, such as healthcare workers. Custom-made foot orthoses with a medial wedge have proven effective in improving comfort and correcting certain biomechanical alterations, even in asymptomatic individuals. The study described has two main objectives: * to validate the Italian version of the Foot Health Status Questionnaire (FHSQ), already validated in English and Spanish, by assessing its reliability and reproducibility as a tool to measure foot health. * through a pilot study, to analyze the effects of using specific professional footwear in healthcare workers with hyperpronation, evaluating perceived benefits in terms of pain reduction and postural improvement.
Interventions
- Device Medially wedged ortheses
3 month long wear of medially wedged ortheses. Ortheses have to be worn for 6 to 8 hours daily during work shifts.
Primary outcome measures
- FHSQ [Time frame: 3 months]
Secondary outcome measures (3)
- GAITLAB [Time frame: Baseline]
- GAITLAB [Time frame: Baseline]
- GAITLAB [Time frame: Baseline]
Eligibility criteria
Inclusion criteria
- Healthworker (attendings, residents, OR nurses, ER nurses, therapists...)
- Maximum age inferior to 65 y.o. at recruitment time
- Partecipants stands from 60% to 80% of their working time
- Uses mostly healthcare shoes while working
- Hyperpronation condition
- No other pathologic condition of the feet
- Partecipants accept to wear medially wedged orthesis for at least 3 months
- Signatures of consensus to join the study
- Partecipants must be aware of the implication of the study
Exclusion criteria
- Other pathologic condition of the foot
- Age superiore to 65 y.o. at the recruitment time
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- ASST Gaetano Pini-CTO — Milan
Publications
- Landorf KB, Radford JA, Hudson S. Minimal Important Difference (MID) of two commonly used outcome measures for foot problems. J Foot Ankle Res. 2010 May 14;3:7. doi: 10.1186/1757-1146-3-7. PMID 20465855
- Landorf KB, Twyford GN, Cotchett MP, Whittaker GA. Revised minimal important difference values for the visual analogue scale and Foot Health Status Questionnaire when used for plantar heel pain. J Foot Ankle Res. 2024 Dec;17(4):e70021. doi: 10.1002/jfa2.70021. PMID 39682003
- Munteanu SE, Zammit GV, Menz HB, Landorf KB, Handley CJ, Elzarka A, Deluca J. Effectiveness of intra-articular hyaluronan (Synvisc, hylan G-F 20) for the treatment of first metatarsophalangeal joint osteoarthritis: a randomised placebo-controlled trial. Ann Rheum Dis. 2011 Oct;70(10):1838-41. doi: 10.1136/ard.2011.153049. Epub 2011 Jul 25. PMID 21791454
- Menz HB, Auhl M, Tan JM, Levinger P, Roddy E, Munteanu SE. Effectiveness of Foot Orthoses Versus Rocker-Sole Footwear for First Metatarsophalangeal Joint Osteoarthritis: Randomized Trial. Arthritis Care Res (Hoboken). 2016 May;68(5):581-9. doi: 10.1002/acr.22750. PMID 26638878
- Chuter VH, Searle A, Spink MJ. Flip-flop footwear with a moulded foot-bed for the treatment of foot pain: a randomised controlled trial. BMC Musculoskelet Disord. 2016 Nov 11;17(1):468. doi: 10.1186/s12891-016-1327-x. PMID 27835963
- Landorf KB, Keenan AM, Herbert RD. Effectiveness of foot orthoses to treat plantar fasciitis: a randomized trial. Arch Intern Med. 2006 Jun 26;166(12):1305-10. doi: 10.1001/archinte.166.12.1305. PMID 16801514
- Riskowski JL, Hagedorn TJ, Hannan MT. Measures of foot function, foot health, and foot pain: American Academy of Orthopedic Surgeons Lower Limb Outcomes Assessment: Foot and Ankle Module (AAOS-FAM), Bristol Foot Score (BFS), Revised Foot Function Index (FFI-R), Foot Health Status Questionnaire (FHSQ), Manchester Foot Pain and Disability Index (MFPDI), Podiatric Health Questionnaire (PHQ), and Rowa PMID 22588747
- Cuesta-Vargas A, Bennett P, Jimenez-Cebrian AM, Labajos-Manzanares MT. The psychometric properties of the Spanish version of the Foot Health Status Questionnaire. Qual Life Res. 2013 Sep;22(7):1739-43. doi: 10.1007/s11136-012-0287-3. Epub 2012 Oct 12. PMID 23065118
Identifiers
NCT: NCT07000838 · ORTHOPROnew