Foot Orthoses in the Treatment of Painful Hallux Valgus
ConditionHallux Valgus
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-74
SponsorUniversité du Québec à Trois-Rivières
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Sham Foot orthoses
Other interventionParticipants 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 Education
Other interventionAll 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.
Exercise
Other interventionParticipants 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 orthoses
Other interventionParticipants 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 orthoses
Other interventionParticipants 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.
Treatment groups
36 Participants
are divided into 3 treatment groupsGroup A: Control groupSham comparator 3 interventions
Group B: Customized foot orthoses groupExperimental treatment 3 interventions
Group C: Prefabricated foot orthoses groupExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Recruitment rate
The number of participants recruited per month.
Time frame
Baseline2
Conversion rate
The proportion of individuals providing consent to participate from those who met the selection criteria.
Time frame
Baseline3
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 weeks4
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 weeksSecondary outcomes
1
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 treatment2
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 treatment3
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 treatment4
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 treatmentSponsors and contacts
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Source ClinicalTrials.gov
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