Hallux Valgus
Conditions
Keywords
Customized foot orthoses, Prefabricated foot orthoses, Pain, Function, Randomized controlled trial
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.
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.
Interventions
OTHERSham 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.
OTHERPodiatric Education
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.
OTHERExercise
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.
Sponsors
Université du Québec à Trois-Rivières
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 18 to 74 years; 2. 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; 3. Can walk without assistive devices (e.g., cane, walker); 4. Are willing to wear shoes that accommodate their foot orthoses daily; 5. Are willing to minimize the use of other interventions (e.g., pain medications, physical therapy) during the trial period.
Exclusion criteria
1. Inflammatory conditions (e.g., arthritis, gout), neurological diseases and other sources of mechanical foot pain; 2. History of orthopedic foot surgery; 3. Prior use of custom or prefabricated foot orthoses in the past 12 weeks; 4. Cognitive impairment; 5. Currently pregnant or breastfeeding; 6. Participation in foot exercises within the past 12 weeks; 7. Less than 10 degrees range of motion at the first metatarsophalangeal joint.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 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. |
| Recruitment rate | Baseline | The number of participants recruited per month. |
| Conversion rate | Baseline | The proportion of individuals providing consent to participate from those who met the selection criteria. |
| Foot orthoses average wear time | From baseline to end of treatment at 12 weeks | Average number of hours the FOs are worn per day. |
| Adherence to the exercise program | From allocation to end of treatment at 12 weeks | The average number of days the exercise program was performed weekly. |
| Credibility and Expectancy of the Intervention questionnaire | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Foot Function Index | At baseline and after 6 and 12 weeks of treatment | 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) |
| Mean and maximal pain during walking during the past week | At baseline and after 6 and 12 weeks of treatment | 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) |
| Global rating of change | After 6 and 12 weeks of treatment | 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") |
| Health-related quality of life | At baseline and after 6 and 12 weeks of treatment | 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. |
Countries
Canada
Contacts
CONTACTGabriel Moisan, DPM PhD
Outcome results
None listed