Efficacy of Splinting, Exercise and Electrotherapy on Hallux Valgus

Study Overview
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Brief Summary
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The aim of this study was to investigate the effects of splinting, exercise and electrotherapy on the hallux valgus (HV) angle, and foot-specific health-related quality of life. Sixty women (120 feet) with bilateral HV deformity were randomly assigned to one of three groups - an HV night splint (SP) group, an exercise (EX) group, and a high-voltage galvanic stimulation (EL) group. Angular degrees (hallux interphalangeal, HV, and intermetatarsal angles expressed as angles A, B and C, respectively) were determined before enrollment (t0) and three months after treatment (t2). Foot-specific quality of life was assessed using the Manchester-Oxford Foot Questionnaire (MOFQ) at t0, after one month (t1), and at t2. All groups exhibited significant changes in the A, B, and C angles and outcome measures (p ≤0.001). Decreases in the A and C angles, and MOFQ-Pain subscale scores, were higher in the SP group than in the other two groups (p<0.05). C angle at t2, MOFQ-Walking score at t1 and t2 and MOFQ-Pain subscale score at t1 were lower in the SP group (p<0.05).

Official Title
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A Comparison of the Effectiveness of Splinting, Exercise and Electrotherapy in the Management of Hallux Valgus: a Randomized Clinical Trial

Conditions
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Hallux Valgus

Intervention / Treatment
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* Device: hallux valgus night splint
* Other: exercise
* Other: Electrotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: a diagnosis of HV confirmed by an orthopedist experienced in foot surgery female gender bilateral HV deformity aged 18-60 years. Patients were then selected based on an HV deformity degree of '2' or '3' on the Manchester scale before randomization Exclusion Criteria: Patients with HV deformity degrees less than '2' or more than '3' according to the Manchester scale Patients with systemic disease, cognitive or mental disturbance, a history of surgery to the lower extremity, or previous use of any foot splints were excluded.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HV night splint (SP) group<br> | Device: hallux valgus night splint<br>* The HV night splint holds the hallux in abduction in order to provide a correct position. The SP group was given splints consisting of a rigid polyethylene bar along the medial of the hallux, and soft polyform and Velcro fastener parts.<br>|
| Active Comparator: exercise (EX) group<br> | Other: exercise<br>* The exercises involved strengthening the AbdH (abductor hallucis) and plantar fascia muscles, and stretching the hallux<br>|
| Active Comparator: high-voltage galvanic stimulation (EL) group<br> | Other: Electrotherapy<br>* Two self-adhesive electrodes were used. One was placed over the medial distal end of the first metatarsal and the other was attached to the motor point of the AbdH (inferior and posterior to the navicular tuberosity).21 The stimulation intensity was increased until a contraction was observed without causing discomfort and pain. Twenty-minute HVPGS was applied in total over three weekly sessions for four weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Manchester Scale | This scale determines the severity of HV and deformity using four foot photographs (0 'no deformity', 1 'mild', 2 'moderate' or 3: 'severe deformity'). | used once before enrollment for the inclusion | 
| change in hallux valgus angle | Antero-posterior radiographs of patients' bilateral feet were taken before treatment and at three-month follow-up controls (in a standing position). HV, intermetatarsal, and hallux interphalangeal angles were measured on the radiographic images. These angles were abbreviated to angles A, B and C respectively. | were taken before enrollment and at three-month follow-up controls | 
| change in Manchester-Oxford Foot Questionnaire score | MOFQ Foot health-related quality of life was evaluated using the MOFQ. This consists of three categories - pain, walking/standing, and social interaction. The MOFQ contains 16 items, each scored on a Likert scale between 0 and 4. Possible scores for each domain range from 0 to 100, with higher scores indicating the most severe conditions | were assessed three times: before enrollment, at 1st and 3rd months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hallux valgus, Night splint, Exercise, High voltage galvanic stimulation, Radiographic angular degree, Foot-specific health-related quality of life