An interventional study of Sham Foot orthoses and Podiatric Education in Hallux Valgus, sponsored by Université du Québec à Trois-Rivières. Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years to 74 Years. Per ClinicalTrials.gov, last updated 2026-08-24.
Sponsored by Université du Québec à Trois-Rivières · Not applicable, Interventional, and Treatment
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.
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.
157 studies on the registry are indexed under Hallux Valgus; 36 are open to participants now.
This study's planned enrollment of 36 is below the median of 58 across 119 interventional studies indexed under Hallux Valgus.
Browse Hallux Valgus studies →Université du Québec à Trois-Rivières is the lead sponsor of 40 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
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.
Other: Sham Foot orthoses · Other: Podiatric Education · Other: Exercise
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.
Other: Podiatric Education · Other: Exercise · Other: Customized foot orthoses
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.
Other: Podiatric Education · Other: Exercise · Other: Prefabricated foot orthoses
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.
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.
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.
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
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.
Recruitment rate
The number of participants recruited per month.
Time frame: Baseline
Conversion rate
The proportion of individuals providing consent to participate from those who met the selection criteria.
Time frame: Baseline
Foot orthoses average wear time
Average number of hours the FOs are worn per day.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline
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)
Time frame: 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)
Time frame: 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")
Time frame: 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.
Time frame: At baseline and after 6 and 12 weeks of treatment
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Jan 2027; primary completion for Dec 2027, 11 months later.
Of 51 non-industry interventional studies with no phase under Hallux Valgus, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 55. This study's planned 11 months is below that.
Counting every sponsor, half of 56 studies reached it within 26 months; a quarter within 11 and three quarters within 55.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Université du Québec à Trois-Rivières