Hallux ValgusNCT07781735
Foot Orthoses in the Treatment of Painful Hallux Valgus
A study testing Podiatric Education, Exercise and Prefabricated foot orthoses in people with Hallux Valgus, run by Université du Québec à Trois-Rivières at 1 site in Canada.
Trial summary
This randomized pilot feasibility trial will evaluate the feasibility of conducting a full-scale randomized controlled trial comparing custom-made, prefabricated, and sham foot orthoses in people with painful hallux valgus. All participants will also receive a standardized program of foot exercises and education. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Hallux Valgus
- What is being tested?
- Podiatric Education, Exercise and Prefabricated foot orthoses
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2027to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 74 years;
- Have unilateral or bilateral hallux valgus (Manchester scale ≥ 2) with pain for at least 3 months (average pain score ≥ 3 out of 10 on a Visual Analogue Scale (VAS)) that is aggravated by weight-bearing activities. If participants have bilateral hallux valgus, the most painful foot will be used for data collection. Participants with pain secondary to friction between the first metatarsophalangeal joint and the shoe will be excluded unless the intra-articular or plantar pain is more significant;
- Can walk without assistive devices (e.g., cane, walker);
- Are willing to wear shoes that accommodate their foot orthoses daily;
- Are willing to minimize the use of other interventions (e.g., pain medications, physical therapy) during the trial period.
Who cannot join
- Inflammatory conditions (e.g., arthritis, gout), neurological diseases and other sources of mechanical foot pain;
- History of orthopedic foot surgery;
- Prior use of custom or prefabricated foot orthoses in the past 12 weeks;
- Cognitive impairment;
- Currently pregnant or breastfeeding;
- Participation in foot exercises within the past 12 weeks;
- Less than 10 degrees range of motion at the first metatarsophalangeal joint.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Université du Québec à Trois-Rivières
Trois-Rivières, Quebec, G9A5H7
Gabriel Moisan, DPM PhD, 819 376-5011 ext. 3606, gabriel.moisan@uqtr.ca
About this study
Official title: Randomized Pilot Feasibility Trial on the Clinical Effects of Custom and Prefabricated Foot Orthoses in Patients With Painful Hallux Valgus.
This randomized pilot feasibility trial will evaluate the feasibility of conducting a full-scale randomized controlled trial comparing custom-made, prefabricated, and sham foot orthoses in people with painful hallux valgus. All participants will also receive a standardized program of foot exercises and education. Thirty-six participants will be randomized to one of the three intervention groups and assessed at baseline, 6 weeks, and 12 weeks. The primary outcomes will assess the feasibility of recruitment, retention, treatment adherence, intervention credibility and expectancy, and use of cointerventions. Secondary outcomes will assess foot pain and function, perceived clinical improvement, and health-related quality of life. The findings will inform the design and conduct of a future full-scale randomized controlled trial.
Read the detailed description
Background: Hallux valgus is a common foot deformity that causes significant pain, limits function and negatively impacts health-related quality of life. Foot orthoses (FOs), whether custom-made or prefabricated, are often prescribed to alleviate symptoms and improve function. However, their clinical effectiveness in individuals with painful hallux valgus remains unclear. The primary objective of this trial is to evaluate the feasibility of conducting a full-scale randomized controlled trial comparing three multifaceted interventions combining foot exercises and education with custom FOs, prefabricated FOs, or sham FOs in patients with painful hallux valgus.
Methods/design: This participant-blinded, superiority, randomized pilot feasibility trial with three parallel groups will be conducted in Trois-Rivières, Canada. Thirty-six participants with painful hallux valgus will be recruited from the Université du Québec à Trois-Rivières outpatient podiatry clinic and through social media advertisements. Participants will be randomized to receive custom, prefabricated, or sham FOs. All groups will also receive a program of foot exercises and education about their condition. Participants will be evaluated at baseline and at 6- and 12-weeks time points. The primary feasibility outcomes will include recruitment rate, conversion rate, retention rate, adherence to treatment, intervention credibility and expectancy, and use of cointerventions. Secondary efficacy outcomes will include foot pain and limitations (Foot Function Index; average and maximal daily pain), self-assessed clinical progress (Global Rating of Change), and health-related quality of life (EQ-5D-5L).
Discussion: This trial will determine the feasibility of conducting a full-scale randomized controlled trial comparing the efficacy of custom and prefabricated FOs in reducing pain and improving function in patients with a painful hallux valgus.
- Conditions
- Hallux Valgus
- Being tested
- Sham Foot orthoses, Podiatric Education, Exercise, Prefabricated foot orthoses, Customized foot orthoses
- Keywords
- Customized foot orthoses, Prefabricated foot orthoses, Pain, Function, Randomized controlled trial
- Medical subject headings
- Hallux Valgus, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham Foot orthosesOther
Participants will receive bilateral 3D-printed sham foot orthoses manufactured from low-stiffness FilaForm material. The sham orthoses will have an appearance similar to the customized orthoses but will provide negligible mechanical support, thereby maintaining participant blinding.
Podiatric EducationOther
All participants will receive the same evidence-based information and clinical guidance at the start of the trial, and will follow a 5-day familiarization protocol with progressive foot orthoses wear time, starting at 1 hour per day and increasing by 1 hour daily up to 5 hours per day. Following familiarization, participants will be instructed to wear their assigned FOs during all standing activities, targeting a minimum of 5 hours per day, for the 12-week intervention period.
ExerciseOther
Participants will perform at home, unsupervised, the short foot exercise, the hallux flexion exercise and the big toe pull exercise. Exercises will be required to be performed at least four times per week for 12 weeks. As a motivational strategy, participants will be informed that these exercises target muscles known to be weakened in individuals with hallux valgus. They will be instructed to progressively increase the resistance of the rubber band as needed during the 12-week duration of the trial to ensure that the exercises are difficult to complete, without causing pain. Participants will have access to videos and handouts describing the exercises.
Prefabricated foot orthosesOther
Participants randomized in this group will receive PowerStep Pinnacle Maxx Support prefabricated FOs for both feet. The top cover will be made of a polyester fabric. The structural arch support will consist of a polypropylene shell incorporating a 2° medial post. A dual-layer system composed of a black foam top layer and a black ethylene-vinyl acetate (EVA) base layer will also be included
Customized foot orthosesOther
Participants randomized in this group will receive custom foot orthoses for both feet. Custom foot orthoses will be 3D printed (Fuse 1+30W, Formlabs, USA) in PA-11 (2.6 mm if the participants' weight (PW) is inferior or equal to 45 kg; 3.2 mm if 45<PW<100 kg; 4.0 mm if PW>100 kg) with a rearfoot post, a full-length 2 mm EVA top cover over a 3 mm Poron top cover. A kinetic wedge in the Poron top cover (isolation under the 1st metatarsophalangeal joint) will also be added.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Sham comparator | Participants randomized to this group will receive 3D printed sham foot orthoses in combination with standardized podiatric education and a home-based progressive exercise program. Receives: Other: Sham Foot orthoses; Other: Podiatric Education; Other: Exercise |
| Customized foot orthoses group | Experimental | Participants randomized to this group will receive customized 3D printed foot orthoses in combination with standardized podiatric education and a home-based progressive exercise program. Receives: Other: Podiatric Education; Other: Exercise; Other: Customized foot orthoses |
| Prefabricated foot orthoses group | Experimental | Participants randomized to this group will receive prefabricated foot orthoses covered by in combination with standardized podiatric education and a home-based progressive exercise program. Receives: Other: Podiatric Education; Other: Exercise; Other: Prefabricated foot orthoses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
The number of participants recruited per month.
Measured: Baseline
Conversion rate
The proportion of individuals providing consent to participate from those who met the selection criteria.
Measured: Baseline
Foot orthoses average wear time
Average number of hours the FOs are worn per day.
Measured: From baseline to end of treatment at 12 weeks
Adherence to the exercise program
The average number of days the exercise program was performed weekly.
Measured: From allocation to end of treatment at 12 weeks
Adverse events
Participants will be asked to report adverse events they encounter, body location and severity. Adverse events will be classified as unrelated, probably related or definitely related to their participation in the trial.
Measured: From allocation to end of treatment at 12 weeks
Credibility and Expectancy of the Intervention questionnaire
The Credibility and Expectancy of the Intervention questionnaire (CEQ) is a widely used, valid, and reliable self-administered questionnaire designed to assess participants' perceptions of the credibility of an intervention and their expectations regarding its potential effectiveness (23). It consists of 6 items divided into two domains: treatment credibility (3 items) and expectancy of improvement (3 items). The credibility subscale evaluates how logical and convincing participants perceive the intervention to be, while the expectancy subscale assesses the degree to which participants believe the intervention will improve their condition. Scores from both subscales will be analyzed to evaluate participants' perceptions of the intervention.
Measured: Baseline
Secondary outcomes (4)
Foot Function Index
The Foot Function Index is a widely used, valid, and reliable self-administered questionnaire consisting of 23 items grouped into 3 domains: foot pain (9 items), disability (9 items), and activity limitation (5 items)
Measured: At baseline and after 6 and 12 weeks of treatment
Mean and maximal pain during walking during the past week
Mean and maximal pain during walking for the most painful foot during the past week: visual analog scale (from 0 to 10, 0 being no pain and 10 pain as bad as it could be)
Measured: At baseline and after 6 and 12 weeks of treatment
Global rating of change
Participants' perception of overall treatment effect will be measured using the self-reported global rating of change scale (25). This outcome will then be dichotomized into the categories of "effective" ("a very great deal better", "a great deal better", "a good deal better" and "moderately better") and "ineffective" ("somewhat better", "a little better", "about the same, hardly any better at all", "no change", "about the same, hardly any worse at all", "a little worse", "somewhat worse", "moderately worse", "a good deal worse", "a great deal worse" and 'a very great deal worse")
Measured: After 6 and 12 weeks of treatment
Health-related quality of life
the 5-level EQ-5D (EQ-5D-5L) will be used (27). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has five levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The participant will be asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Measured: At baseline and after 6 and 12 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study startJan 2027 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université du Québec à Trois-Rivières
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07781735
- Sponsor's protocol ID
- 2026_UQTR_HAV_RCT
- Status last verified
- Aug 2026
- First submitted
- 17 Aug 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Pilot Feasibility Trial on the Clinical Effects of Custom and Prefabricated Foot Orthoses in Patients With Painful Hallux Valgus.
- ClinicalTrials.gov ID
- NCT07781735
- Acronym / sponsor ID
- 2026_UQTR_HAV_RCT
- Conditions
- Hallux Valgus
- Keywords
- Customized foot orthoses, Prefabricated foot orthoses, Pain, Function, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Université du Québec à Trois-RivièresUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 24 Aug 2026 (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.
This randomized pilot feasibility trial will evaluate the feasibility of conducting a full-scale randomized controlled trial comparing custom-made, prefabricated, and sham foot orthoses in people with painful hallux valgus. All participants will also receive a standardized program of foot exercises and education. Thirty-six participants will be randomized to one of the three intervention groups and assessed at baseline, 6 weeks, and 12 weeks. The primary outcomes will assess the feasibility of recruitment, retention, treatment adherence, intervention credibility and expectancy, and use of cointerventions. Secondary outcomes will assess foot pain and function, perceived clinical improvement, and health-related quality of life. The findings will inform the design and conduct of a future full-scale randomized controlled trial.
Detailed description
Background: Hallux valgus is a common foot deformity that causes significant pain, limits function and negatively impacts health-related quality of life. Foot orthoses (FOs), whether custom-made or prefabricated, are often prescribed to alleviate symptoms and improve function. However, their clinical effectiveness in individuals with painful hallux valgus remains unclear. The primary objective of this trial is to evaluate the feasibility of conducting a full-scale randomized controlled trial comparing three multifaceted interventions combining foot exercises and education with custom FOs, prefabricated FOs, or sham FOs in patients with painful hallux valgus.
Methods/design: This participant-blinded, superiority, randomized pilot feasibility trial with three parallel groups will be conducted in Trois-Rivières, Canada. Thirty-six participants with painful hallux valgus will be recruited from the Université du Québec à Trois-Rivières outpatient podiatry clinic and through social media advertisements. Participants will be randomized to receive custom, prefabricated, or sham FOs. All groups will also receive a program of foot exercises and education about their condition. Participants will be evaluated at baseline and at 6- and 12-weeks time points. The primary feasibility outcomes will include recruitment rate, conversion rate, retention rate, adherence to treatment, intervention credibility and expectancy, and use of cointerventions. Secondary efficacy outcomes will include foot pain and limitations (Foot Function Index; average and maximal daily pain), self-assessed clinical progress (Global Rating of Change), and health-related quality of life (EQ-5D-5L).
Discussion: This trial will determine the feasibility of conducting a full-scale randomized controlled trial comparing the efficacy of custom and prefabricated FOs in reducing pain and improving function in patients with a painful hallux valgus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Sham comparator | Other: Sham Foot orthoses, Other: Podiatric Education, Other: ExerciseParticipants randomized to this group will receive 3D printed sham foot orthoses in combination with standardized podiatric education and a home-based progressive exercise program. |
| Customized foot orthoses group | Experimental | Other: Podiatric Education, Other: Exercise, Other: Customized foot orthosesParticipants randomized to this group will receive customized 3D printed foot orthoses in combination with standardized podiatric education and a home-based progressive exercise program. |
| Prefabricated foot orthoses group | Experimental | Other: Podiatric Education, Other: Exercise, Other: Prefabricated foot orthosesParticipants randomized to this group will receive prefabricated foot orthoses covered by in combination with standardized podiatric education and a home-based progressive exercise program. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18 to 74 years;
- Have unilateral or bilateral hallux valgus (Manchester scale ≥ 2) with pain for at least 3 months (average pain score ≥ 3 out of 10 on a Visual Analogue Scale (VAS)) that is aggravated by weight-bearing activities. If participants have bilateral hallux valgus, the most painful foot will be used for data collection. Participants with pain secondary to friction between the first metatarsophalangeal joint and the shoe will be excluded unless the intra-articular or plantar pain is more significant;
- Can walk without assistive devices (e.g., cane, walker);
- Are willing to wear shoes that accommodate their foot orthoses daily;
- Are willing to minimize the use of other interventions (e.g., pain medications, physical therapy) during the trial period.
Key exclusion criteria (7 listed)
- Inflammatory conditions (e.g., arthritis, gout), neurological diseases and other sources of mechanical foot pain;
- History of orthopedic foot surgery;
- Prior use of custom or prefabricated foot orthoses in the past 12 weeks;
- Cognitive impairment;
- Currently pregnant or breastfeeding;
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 |
|---|---|---|
| Sham Foot orthosesParticipants will receive bilateral 3D-printed sham foot orthoses manufactured from low-stiffness FilaForm material. The sham orthoses will have an appearance similar to the customized orthoses but will provide negligible mechanical support, thereby maintaining participant blinding. | Other | Control group |
| Podiatric EducationAll participants will receive the same evidence-based information and clinical guidance at the start of the trial, and will follow a 5-day familiarization protocol with progressive foot orthoses wear time, starting at 1 hour per day and increasing by 1 hour daily up to 5 hours per day. Following familiarization, participants will be instructed to wear their assigned FOs during all standing activities, targeting a minimum of 5 hours per day, for the 12-week intervention period. | Other | Control group, Customized foot orthoses group, Prefabricated foot orthoses group |
| ExerciseParticipants will perform at home, unsupervised, the short foot exercise, the hallux flexion exercise and the big toe pull exercise. Exercises will be required to be performed at least four times per week for 12 weeks. As a motivational strategy, participants will be informed that these exercises target muscles known to be weakened in individuals with hallux valgus. They will be instructed to progressively increase the resistance of the rubber band as needed during the 12-week duration of the trial to ensure that the exercises are difficult to complete, without causing pain. Participants will have access to videos and handouts describing the exercises. | Other | Control group, Customized foot orthoses group, Prefabricated foot orthoses group |
| Prefabricated foot orthosesParticipants randomized in this group will receive PowerStep Pinnacle Maxx Support prefabricated FOs for both feet. The top cover will be made of a polyester fabric. The structural arch support will consist of a polypropylene shell incorporating a 2° medial post. A dual-layer system composed of a black foam top layer and a black ethylene-vinyl acetate (EVA) base layer will also be included | Other | Prefabricated foot orthoses group |
| Customized foot orthosesParticipants randomized in this group will receive custom foot orthoses for both feet. Custom foot orthoses will be 3D printed (Fuse 1+30W, Formlabs, USA) in PA-11 (2.6 mm if the participants' weight (PW) is inferior or equal to 45 kg; 3.2 mm if 45<PW<100 kg; 4.0 mm if PW>100 kg) with a rearfoot post, a full-length 2 mm EVA top cover over a 3 mm Poron top cover. A kinetic wedge in the Poron top cover (isolation under the 1st metatarsophalangeal joint) will also be added. | Other | Customized foot orthoses group |
Primary outcome
Recruitment rate
Time frame: Baseline
The number of participants recruited per month.
Conversion rate
Time frame: Baseline
The proportion of individuals providing consent to participate from those who met the selection criteria.
Foot orthoses average wear time
Time frame: From baseline to end of treatment at 12 weeks
Average number of hours the FOs are worn per day.
Adherence to the exercise program
Time frame: From allocation to end of treatment at 12 weeks
The average number of days the exercise program was performed weekly.
Adverse events
Time frame: From allocation to end of treatment at 12 weeks
Participants will be asked to report adverse events they encounter, body location and severity. Adverse events will be classified as unrelated, probably related or definitely related to their participation in the trial.
Credibility and Expectancy of the Intervention questionnaire
Time frame: Baseline
The Credibility and Expectancy of the Intervention questionnaire (CEQ) is a widely used, valid, and reliable self-administered questionnaire designed to assess participants' perceptions of the credibility of an intervention and their expectations regarding its potential effectiveness (23). It consists of 6 items divided into two domains: treatment credibility (3 items) and expectancy of improvement (3 items). The credibility subscale evaluates how logical and convincing participants perceive the intervention to be, while the expectancy subscale assesses the degree to which participants believe the intervention will improve their condition. Scores from both subscales will be analyzed to evaluate participants' perceptions of the intervention.
4 secondary outcomes
Foot Function Index
Time frame: At baseline and after 6 and 12 weeks of treatment
Mean and maximal pain during walking during the past week
Time frame: At baseline and after 6 and 12 weeks of treatment
Global rating of change
Time frame: After 6 and 12 weeks of treatment
Health-related quality of life
Time frame: At baseline and after 6 and 12 weeks of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Podiatric Education, Exercise and Prefabricated foot orthoses in people with Hallux Valgus, run by Université du Québec à Trois-Rivières at 1 site in Canada.
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 7 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: opening soon, as of the sponsor's last update on 24 Aug 2026. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gabriel Moisan, DPM PhD (819 376-5011 ext. 3606, gabriel.moisan@uqtr.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Aug 2026.