Foot Orthoses in the Treatment of Painful Hallux Valgus

NCT07781735 | Not Yet Recruiting

• 1 other identifier: 2026_UQTR_HAV_RCT
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Hallux Valgus

Keywords

Customized foot orthoses; Prefabricated foot orthoses; Pain; Function; Randomized controlled trial

Outcome Measures

Primary Outcomes (6)

• Recruitment rate

  The number of participants recruited per month.

  Baseline

• Conversion rate

  The proportion of individuals providing consent to participate from those who met the selection criteria.

  Baseline

• Foot orthoses average wear time

  Average number of hours the FOs are worn per day.

  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.

  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.

  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.

  Baseline

Secondary Outcomes (4)

• Foot Function Index

  At baseline and after 6 and 12 weeks of treatment

• Mean and maximal pain during walking during the past week

  At baseline and after 6 and 12 weeks of treatment

• Global rating of change

  After 6 and 12 weeks of treatment

• Health-related quality of life

  At baseline and after 6 and 12 weeks of treatment

Study Arms (3)

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.

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.

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.

Other: Podiatric Education; Other: Exercise; Other: Prefabricated foot orthoses

Interventions

Sham Foot orthoses OTHER

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.

Control group

Podiatric Education OTHER

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.

Control group; Customized foot orthoses group; Prefabricated foot orthoses group

Exercise OTHER

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.

Control group; Customized foot orthoses group; Prefabricated foot orthoses group

Prefabricated foot orthoses OTHER

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

Prefabricated foot orthoses group

Customized foot orthoses OTHER

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.

Customized foot orthoses group

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Université du Québec à Trois-Rivières: lead

Study Sites (1)

Université du Québec à Trois-Rivières

Trois-Rivières, Quebec, G9A5H7, Canada

Location

MeSH Terms

Conditions

Hallux Valgus; Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Foot Deformities; Musculoskeletal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Gabriel Moisan, DPM PhD

CONTACT

819 376-5011; gabriel.moisan@uqtr.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2026
• First Posted: August 24, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 24, 2026

Record last verified: 2026-08

Locations

CA (1)