Effects of Customized Insoles for Individuals With Symptomatic Hallux Valgus

NCT05408156 | Not Yet Recruiting DMC

• 1 other identifier: UFRNHáluxValgus
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Hallux Valgus; Foot Diseases; Foot Deformities

Keywords

hallux valgus; insoles; pain

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline, 6 weeks, 12 weeks, 16 weeks

Secondary Outcomes (5)

• Change in Foot Function Index (FFI)

  baseline, 6 weeks, 12 weeks, 16 weeks

• Change in Treatment expectation

  baseline

• Change in Self-assessment of treatment

  16 weeks

• Change in Blinding test

  16 weeks

• Change in Hours of insole use

  16 weeks

Study Arms (2)

Customized insoles group

EXPERIMENTAL

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

Sham Insoles Group

SHAM COMPARATOR

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

Interventions

Insoles OTHER

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)

Customized insoles group; Sham Insoles Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Federal do Rio Grande do Norte: lead

Study Sites (1)

Marcelo Cardoso de Souza

Natal, Rio Grande do Norte, 59200-000, Brazil

Location

Related Publications (2)

• 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.

  PMID: 31808352 RESULT

• Cavalcanti RR, Mendes AAMT, Barbosa GM, de Souza MC. Effects of custom insoles for symptomatic hallux valgus: protocol for a sham-controlled randomised trial. BMJ Open. 2023 Jul 3;13(7):e069872. doi: 10.1136/bmjopen-2022-069872.

  PMID: 37400239 DERIVED

MeSH Terms

Conditions

Hallux Valgus; Foot Diseases; Foot Deformities; Pain

Interventions

Foot Orthoses

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Officials

• Marcelo C de Souza, PT, PhD

  Universidade Federal do Rio Grande do Norte

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcelo C de Souza, PT, PhD

CONTACT

558432912411; marcelo.cardoso@ufrn.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All assessments will be performed by researcher A, who will not be involved with the interventions and will remain blind to the identification of groups. The results of the evaluations will be delivered to researcher C, a researcher with experience in making the insoles, so that they can be made. GPC participants will receive the insoles according to the assessment measurements, five days after the assessment start date. Each participant will remain identified by numbers and not names. Participants will be informed about the purpose of the study to compare the two interventions using customized insoles. In order not to compromise the blinding of the study, all participants will be submitted to the same evaluation before the production and delivery of the insoles. When the insoles are ready, participants will be scheduled for removal at different times, avoiding possible meetings or exchange of information.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Professor

Model Details: Customized insoles group and Sham Insoles Group

Study Record Dates

• First Submitted: May 26, 2022
• First Posted: June 7, 2022
• Study Start: August 1, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 21, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)