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Effects of Customized Insoles for Individuals With Symptomatic Hallux Valgus

Primary Purpose

Hallux Valgus, Foot Diseases, Foot Deformities

Status
Not yet recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Insoles
Sponsored by
Universidade Federal do Rio Grande do Norte
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hallux Valgus focused on measuring hallux valgus, insoles, pain

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Marcelo Cardoso de Souza

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Customized insoles group

Sham Insoles Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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?"
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."
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
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

Full Information

First Posted
May 26, 2022
Last Updated
February 14, 2023
Sponsor
Universidade Federal do Rio Grande do Norte
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1. Study Identification

Unique Protocol Identification Number
NCT05408156
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2024 (Anticipated)
Primary Completion Date
August 1, 2025 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Rio Grande do Norte

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hallux Valgus, Foot Diseases, Foot Deformities
Keywords
hallux valgus, insoles, pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Customized insoles group and Sham Insoles Group
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Customized insoles group
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham Insoles Group
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Insoles
Intervention Description
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)
Primary Outcome Measure Information:
Title
Change in Numerical Pain Scale (END)
Description
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
Secondary Outcome Measure Information:
Title
Change in Foot Function Index (FFI)
Description
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
Title
Change in Treatment expectation
Description
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
Title
Change in Self-assessment of treatment
Description
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
Title
Change in Blinding test
Description
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
Title
Change in Hours of insole use
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marcelo C de Souza, PT, PhD
Phone
558432912411
Email
marcelo.cardoso@ufrn.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcelo C de Souza, PT, PhD
Organizational Affiliation
Universidade Federal do Rio Grande do Norte
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marcelo Cardoso de Souza
City
Natal
State/Province
RN
ZIP/Postal Code
59200-000
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Participant data (IPD) will not be available to other investigators
Citations:
PubMed Identifier
31808352
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.
Results Reference
result

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Effects of Customized Insoles for Individuals With Symptomatic Hallux Valgus

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