An interventional study of Insoles in Hallux Valgus, Foot Diseases and Foot Deformities, sponsored by Universidade Federal do Rio Grande do Norte. Status unknown at 1 site in Brazil. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-05-21.
Sponsored by Universidade Federal do Rio Grande do Norte · Not applicable, Interventional, and Treatment
Hallux valgus is one of the most common forefoot deformities. Its prevalence increases with age, representing approximately 23% in adulthood, being more common in females. Some studies indicate that the use of the insole associated with the finger separator promotes pain relief and that this may be related to better alignment of the hallux. However, there is still no consensus about the ideal insole or how long it should be used to relieve pain or improve function in patients with hallux valgus. Therefore, the objective of this study will be to evaluate the effect of the customized insole on pain and function of individuals with symptomatic hallux valgus.
This is a protocol for a randomized, controlled, blinded clinical trial. Eighty participants with hallux valgus pain will be evaluated and randomized into two intervention groups (40 per group): customized insole group or sham insole group. Assessments will be performed at baseline (T0), after six weeks (T6) and twelve weeks (T12) of insoles use, in addition to the follow-up that will be performed four weeks after the end of the intervention (T16). The primary outcome will be pain, assessed by the Numerical Pain Scale and the secondary outcome will be foot functionality, assessed by the Foot Function Index questionnaire. Statistical analysis: For normal data, analysis of variance with a mixed design will be considered, and for non-normal data, the Friedman test will be used, in addition to the interaction of time per group and intergroup and intragroup differences. The Bonferroni test will be performed in post hoc analyses. Intent-to-treat analysis will be used. A significance level of 5% and CI 95% will be adopted for all statistical analyses.
149 studies on the registry are indexed under Hallux Valgus; 31 are open to participants now.
This study's planned enrollment of 80 is above the median of 60 across 111 interventional studies indexed under Hallux Valgus.
Browse Hallux Valgus studies →Universidade Federal do Rio Grande do Norte is the lead sponsor of 86 studies on the registry; 13 are open to participants now.
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Exclusion Criteria:
The participant allocated in the CIG will receive a semi-flexible non-moulded insole with a 2.5mm coverage with Shore A 28, a 5mm retrocapital bar with a Shore A 22 and a 2mm infracapital bar of the first metatarsal with a Shore A 35, produced in acetate. -ethylene vinyl (EVA) and manufactured by researcher C. The insole will be used on both feet to maintain symmetry between the limbs and generate greater comfort, since this will not be a corrective intervention.
Other: Insoles
The SIG will receive the same unmolded insole with a semi-flexible base and 2.5mm coverage with Shore A 28, but without the bars used in the intervention group.
Other: Insoles
semi-flexible non-moulded insole with a 2.5mm coverage with Shore A 28, a 5mm retrocapital bar with a Shore A 22 and a 2mm infracapital bar of the first metatarsal with a Shore A 35, produced in acetate ethylene vinyl (EVA)
Change in Numerical Pain Scale (END)
Pain intensity will be assessed using the Numerical Pain Scale (END), in which individuals will classify their pain on a numerical scale from 0 to 10 points. This scale will be positioned in front of the participant and will vary from zero to ten points, with zero being the complete absence of pain and ten being the worst pain imaginable by the individual. The quantification of pain intensity will be evaluated at the first steps in the morning and throughout the day.
Time frame: baseline, 6 weeks, 12 weeks, 16 weeks
Change in Foot Function Index (FFI)
Foot functionality will be measured by the Foot Function Index (FFI) questionnaire, which is capable of measuring the impact of foot pathologies related to pain, disability and activity restriction on the function. It consists of 23 items grouped into three subscales, five items related to disability, nine items related to pain and nine items about activity limitation32. The final result will be the average of all domains (the values are added and divided by three). Results can range from 0 to 100% and are directly proportional to the functional impairment of the foot.
Time frame: baseline, 6 weeks, 12 weeks, 16 weeks
Change in Treatment expectation
Treatment expectations will be assessed using a 5-point Likert scale. The following will be asked to participants at T0: "Do you think that by using customized insoles, you will: 1- get much worse, 2 - get worse, 3 - no changes, 4 - improve, or 5 - greatly improve?"
Time frame: baseline
Change in Self-assessment of treatment
A 5-point Likert scale will be used to assess satisfaction with the intervention. Participants will be asked the following question: "How are you feeling after using the insoles?: 1- much worse, 2 - worse, 3 - no changes, 4 - better, or 5 - much better." A 5-point Likert scale will be used to assess satisfaction with the intervention. Participants will be asked the following question: "How are you feeling after using the insoles?: 1- much worse, 2 - worse, 3 - no changes, 4 - better, or 5 - much better."
Time frame: 16 weeks
Change in Blinding test
Participants will be asked which group they believed they were allocated: CIG or SIG. This strategy has been recommended at the end of clinical trials to test whether the blinding strategy adopted was effective Blinding test
Time frame: 16 weeks
Change in Hours of insole use
Participants of both groups will receive an insole control diary to register the number of hours per day spent with the insole. Participants should keep the diary for 12 weeks and return it to researchers at T12. Monitoring and motivation will be performed via telephone or WhatsApp messages to prevent participants from forgetting to use the insole
Time frame: 16 weeks
Plan to share: No — Participant data (IPD) will not be available to other investigators
This study is status unknown, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Universidade Federal do Rio Grande do Norte