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Efficacy of Splinting, Exercise and Electrotherapy on Hallux Valgus

Primary Purpose

Hallux Valgus

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
hallux valgus night splint
exercise
Electrotherapy
Sponsored by
Ankara Yildirim Beyazıt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hallux Valgus focused on measuring hallux valgus, Night splint, Exercise, High voltage galvanic stimulation, Radiographic angular degree, Foot-specific health-related quality of life

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    HV night splint (SP) group

    exercise (EX) group

    high-voltage galvanic stimulation (EL) group

    Arm Description

    Outcomes

    Primary Outcome Measures

    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').
    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.
    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

    Secondary Outcome Measures

    Full Information

    First Posted
    May 13, 2020
    Last Updated
    May 17, 2020
    Sponsor
    Ankara Yildirim Beyazıt University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04393545
    Brief Title
    Efficacy of Splinting, Exercise and Electrotherapy on Hallux Valgus
    Official Title
    A Comparison of the Effectiveness of Splinting, Exercise and Electrotherapy in the Management of Hallux Valgus: a Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2, 2009 (Actual)
    Primary Completion Date
    July 7, 2014 (Actual)
    Study Completion Date
    November 3, 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ankara Yildirim Beyazıt University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hallux Valgus
    Keywords
    hallux valgus, Night splint, Exercise, High voltage galvanic stimulation, Radiographic angular degree, Foot-specific health-related quality of life

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    HV night splint (SP) group
    Arm Type
    Active Comparator
    Arm Title
    exercise (EX) group
    Arm Type
    Active Comparator
    Arm Title
    high-voltage galvanic stimulation (EL) group
    Arm Type
    Active Comparator
    Intervention Type
    Device
    Intervention Name(s)
    hallux valgus night splint
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    exercise
    Intervention Description
    The exercises involved strengthening the AbdH (abductor hallucis) and plantar fascia muscles, and stretching the hallux
    Intervention Type
    Other
    Intervention Name(s)
    Electrotherapy
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Manchester Scale
    Description
    This scale determines the severity of HV and deformity using four foot photographs (0 'no deformity', 1 'mild', 2 'moderate' or 3: 'severe deformity').
    Time Frame
    used once before enrollment for the inclusion
    Title
    change in hallux valgus angle
    Description
    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.
    Time Frame
    were taken before enrollment and at three-month follow-up controls
    Title
    change in Manchester-Oxford Foot Questionnaire score
    Description
    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
    Time Frame
    were assessed three times: before enrollment, at 1st and 3rd months.

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    34388424
    Citation
    Kulunkoglu BA, Akkubak Y, Celik D, Alkan A. A comparison of the effectiveness of splinting, exercise and electrotherapy in women patients with hallux valgus: A randomized clinical trial. Foot (Edinb). 2021 Sep;48:101828. doi: 10.1016/j.foot.2021.101828. Epub 2021 May 25.
    Results Reference
    derived

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    Efficacy of Splinting, Exercise and Electrotherapy on Hallux Valgus

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