Clinical trial NCT05408156: Effects of Customized Insoles for Individuals With Symptomatic Hallux Valgus
Official title: Effects of Customized Insoles for Individuals With Symptomatic Hallux Valgus: Protocol for a Sham-controlled Randomized Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hallux Valgus
Foot Diseases
Foot Deformities
Keywords: hallux valgus
insoles
pain
Lead sponsor: Universidade Federal do Rio Grande do Norte
Sponsor class: OTHER
First posted: 2022-06-07
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Customized insoles group and Sham Insoles Group
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Individuals of both sexes aged over 18 years;
* Presence of mild to moderate hallux valgus, according to the Manchester scale;
* Presenting no hallux with intensity greater than or equal to 3 points up to 8 points, according to the Numerical Pain Scale (END);
* Be available to actively use the insole for at least 4 hours/day;
* Commitment to wear closed shoes, for example (sneakers, shoes used by the patient, due to: wide toe cap and heel height of 2 to 3 cm) during the study.

Exclusion Criteria:

* Being in physical therapy treatment for hallux valgus concomitantly with the research;
* Previous hallux valgus surgeries performed in the last 5 years;
* Presence of foot wounds and wounds, dislocations or metatarsophalangeal fractures in the foot with HV, in the last 5 years
* Presence of diseases such as rheumatoid arthritis, decompensated diabetes, gout, neurodegenerative diseases;
* Cognitive and mental disorder being unable to respond; those related to the study

Primary outcomes:
measure: Change in Numerical Pain Scale (END)
timeFrame: baseline, 6 weeks, 12 weeks, 16 weeks
Secondary outcomes:
measure: Change in Foot Function Index (FFI)
timeFrame: baseline, 6 weeks, 12 weeks, 16 weeks
measure: Change in Treatment expectation
timeFrame: baseline
measure: Change in Self-assessment of treatment
timeFrame: 16 weeks
measure: Change in Blinding test
timeFrame: 16 weeks
measure: Change in Hours of insole use
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Natal
country: Brazil
facility: Marcelo Cardoso de Souza
state: RN
Study officials:
affiliation: Universidade Federal do Rio Grande do Norte
name: Marcelo C de Souza, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Costa ARA, de Almeida Silva HJ, Mendes AAMT, Scattone Silva R, de Almeida Lins CA, de Souza MC. Effects of insoles adapted in flip-flop sandals in people with plantar fasciopathy: a randomized, double-blind clinical, controlled study. Clin Rehabil. 2020 Mar;34(3):334-344. doi: 10.1177/0269215519893104. Epub 2019 Dec 6.