Hallux ValgusNCT05408156
Effects of Customized Insoles for Individuals With Symptomatic Hallux Valgus
A study testing Insoles in people with Hallux Valgus and Foot Diseases, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hallux Valgus, Foot Diseases, Foot Deformities
- What is being tested?
- Insoles
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Aug 2025to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Customized Insoles for Individuals With Symptomatic Hallux Valgus: Protocol for a Sham-controlled Randomized Trial
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.
Read the 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.
- Conditions
- Hallux Valgus, Foot Diseases, Foot Deformities
- Being tested
- Insoles
- Keywords
- hallux valgus, insoles, pain
- Medical subject headings
- Hallux Valgus, Foot Diseases, Foot Deformities, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InsolesOther
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Insoles |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 6 weeks, 12 weeks, 16 weeks
Secondary outcomes (5)
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.
Measured: 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?"
Measured: 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."
Measured: 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
Measured: 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
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start1 Aug 2025 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hallux ValgusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Customized insoles group and Sham Insoles Group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio Grande do Norte
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcelo Cardoso de Souza, PT, PhD., Universidade Federal do Rio Grande do Norte
- Investigators
- Marcelo C de Souza, PT, PhD, Principal investigator, Universidade Federal do Rio Grande do Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05408156
- Sponsor's protocol ID
- UFRNHáluxValgus
- Status last verified
- May 2024
- First submitted
- 26 May 2022
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant data (IPD) will not be available to other investigators
Publications
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.
PubMed 31808352Cavalcanti 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.
PubMed 37400239
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Customized Insoles for Individuals With Symptomatic Hallux Valgus: Protocol for a Sham-controlled Randomized Trial
- ClinicalTrials.gov ID
- NCT05408156
- Acronym / sponsor ID
- UFRNHáluxValgus
- Conditions
- Hallux Valgus, Foot Diseases, Foot Deformities
- Keywords
- hallux valgus, insoles, pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Universidade Federal do Rio Grande do NorteUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 7 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Customized insoles group and Sham Insoles Group
| Arm | Type | Receives |
|---|---|---|
| Customized insoles group | Experimental | Other: InsolesThe 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. |
| Sham Insoles Group | Sham comparator | Other: InsolesThe 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insolessemi-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) | Other | Customized insoles group, Sham Insoles Group |
Primary outcome
Change in Numerical Pain Scale (END)
Time frame: baseline, 6 weeks, 12 weeks, 16 weeks
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.
5 secondary outcomes
Change in Foot Function Index (FFI)
Time frame: baseline, 6 weeks, 12 weeks, 16 weeks
Change in Treatment expectation
Time frame: baseline
Change in Self-assessment of treatment
Time frame: 16 weeks
Change in Blinding test
Time frame: 16 weeks
Change in Hours of insole use
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Results publication: PubMed 31808352Costa 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.
- Derived from this study: PubMed 37400239Cavalcanti 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.
- Individual participant dataSharing planned: No. Participant data (IPD) will not be available to other investigators
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcelo C de Souza, PT, PhD principal investigator
Universidade Federal do Rio Grande do Norte
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insoles in people with Hallux Valgus and Foot Diseases, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marcelo C de Souza, PT, PhD (558432912411, marcelo.cardoso@ufrn.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Numerical Pain Scale (END) (time frame: baseline, 6 weeks, 12 weeks, 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05408156, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2024.