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Randomized Controlled Trial of Custom Foot Orthoses for Chronic Forefoot Pain

ConditionMetatarsalgia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversité du Québec à Trois-Rivières

About this trial

Background Chronic metatarsalgia (CM) causes significant pain and disability, affecting quality of life. Foot orthoses (FOs) including medially wedged designs with a metatarsal pad decrease excessive plantar pressure under the metatarsal heads, which is a suggested risk factor for developing CM. This FOs model may be effective in diminishing pain and improving function in these individuals. Thus, the objective of this trial will be to compare the effects of medially wedged FOs with a metatarsal pad and sham FOs on pain and foot function in individuals with CM.

Methods/design This participant- and assessor-blinded superiority randomized controlled trial (RCT) with two parallel groups will be conducted in Trois-Rivières, Canada. Sixty-four participants with CM will be recruited from the Université du Québec à Trois-Rivières outpatient podiatry clinic and via social media invitations. They will be randomized into intervention (customized FOs) or control (sham FOs) groups and will be evaluated at baseline and after 6 and 12 weeks. The primary outcome will be: (1) mean pain during walking for the most painful foot during the past week. The secondary outcomes will be: (1) Foot Function Index, (2) Global rating of change and (3) the 5-level EQ-5D.

Discussion Medially wedged FOs with a metatarsal pad are expected to provide a greater reduction in pain and improvement in foot function compared to sham FOs. This trial will help guide FOs prescription recommendations for managing foot pain in individuals with CM in the future.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

are aged 18 years or over,

have bilateral or unilateral metatarsalgia under one or more of the lesser metatarsal heads for at least 3 months (pain score of ≥ 4 out of 10 on a Visual Analogue Scale (VAS)) that is aggravated by weight-bearing activities,

are able to walk without assistive devices (e.g., cane, walker),

are willing to wear shoes that will accommodate their FOs on a daily basis and

Disqualifiers

have arthritis,

have neurological diseases (e.g., intermetatarsal neuroma) or other mechanical pain, plantar corns (e.g., intractable plantar keratoma),

have a history of orthopedic foot surgery,

have prior use of customized FOs,

Trial design

Design model

Parallel

Treatments tested in this trial

  • Podiatric advice

    Other intervention

    A podiatrist with 11 years of clinical experience will take the negative foot impressions using a semi-weightbearing method with a foam box for both groups to ensure adequate blinding of participants. Then, the foam boxes of the experimental group will be scanned so that the FOs can be 3D printed. Both groups will receive identical clinical guideline-based information and support at the beginning of the trial. The instructions will be as follows: (1) undertake a familiarization protocol of 14 consecutive full days (2) wear the FOs (customized or sham) at all time when they are standing (targeted minimum of 5 hours per day), (3) avoid positions that cause the metatarsophalangeal joints to dorsiflex (e.g., squatting or tiptoeing), (4) mechanical stress load management according to the tissue stress model, (5) do not walk barefoot and (6) wear shoes with good cushioning in which the FOs will be properly placed.

  • Customized foot orthoses

    Other intervention

    The customized foot orthoses will be manufactured with a Nylon-11 shell with 6° medially wedged forefoot-rearfoot posts (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), a full-length 3 mm Poron top cover and a metatarsal pad (15 shore A) located 5 mm proximal to the metatarsal heads.

  • Sham foot orthoses

    Other intervention

    The molded sham FOs will be manufactured from 3 mm ethylene vinyl acetate. They will have an identical top cover material, color and a similar shape than the customized FOs, however, they will provide negligible mechanical support, considering the very low stiffness of their medial arch. The only impact of these FOs on plantar pressure is under the heel. These devices have been used as a sham condition in previous trials and a study has validated them as being credible.

Treatment groups

64 Participants
are divided into 2 treatment groups
Group A: Intervention GroupExperimental treatment 2 interventions
Group B: Control groupSham comparator 2 interventions

Trial outcomes

Primary outcomes

1

Mean 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
From Baseline to the end of follow-up at 12 weeks

Secondary outcomes

1

Foot Function Index (FFI)

The FFI 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) : we used disability (min: 0, max: 90) and activity limitation (min: 0, max: 50) subscales.

Time frame
From Baseline to the end of follow-up at 12 weeks
2

Global rating of change (GROC)

participants' perception of overall treatment effect will be measured using the self-reported global rating of change scale \[33\]. 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
During the follow-up: 6weeks and 12 weeks
3

Health-related quality of life (HRQoL)

the 5-level EQ-5D (EQ-5D-5L) will be used \[35\]. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 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
From Baseline to the end of follow-up at 12 weeks

Other outcomes

1

Demographic and clinical data

Gender: Male, female, non-binary, transgender or other. Age: in years (from the date of birth) Weight: in kg (measured in clinic) Height: in meters (measured in clinic) Body Mass Index: will be calculated with the formula weight divided by height squared Foot Posture Index: The six clinical criteria used in FPI are: 1. Palpation of the talus head (medial and lateral deviation of the talus head in relation to the navicular bone); 2. Curvature of the supra and lateral inframaleolar region; 3. Position of the calcaneus in the frontal plane; 4. Prominence of the talonavicular region; 5. Congruence of the internal longitudinal arche; and 6. Abduction/adduction of the forefoot with respect to the rearfoot. Each criterion is rated between -2 and +2 and the sum of all gives a total score indicating the foot posture (Normal = 0 to +5; pronated = +6 to +9; highly pronated = +10 to +12; supinated = -1 to -4 and highly supinated = -5 to -12).

Time frame
Baseline
2

Effects of the FOs on plantar pressure

peak plantar pressure during a stance phase (kPa) under the metatarsal heads, measured with a Pedar-X in-shoe pressure measurement system (Novel Corporation, Munich, Germany) with foot orthoses and with shod.

Time frame
Baseline

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Université du Québec à Trois-Rivières

Lead sponsor

Fonds de la Recherche en Santé du Québec

Collaborator

Source ClinicalTrials.gov
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