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
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
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
NCT ID
NCT04393545
First Posted
May 13, 2020
Last Updated
May 17, 2020
Sponsor
Ankara Yildirim Beyazıt University
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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