Efficacy of Splinting, Exercise and Electrotherapy on Hallux Valgus

Not Applicable

Completed

• Conditions: Hallux Valgus
• Interventions: Other: Electrotherapy; Other: exercise; Device: hallux valgus night splint

• Registration Number: NCT04393545
• Lead Sponsor: Ankara Yildirim Beyazıt University

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02-02
• Primary Completion: 2014-07-07
• Study Completion: 2014-11-03
• Status Verified: 2020-05
• Study First Submitted: 2020-05-13
• Study First Submitted QC: 2020-05-17
• Last Update Submitted: 2020-05-17
• Study First Posted: 2020-05-19
• Last Update Posted: 2020-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
high-voltage galvanic stimulation (EL) group	Electrotherapy	-
exercise (EX) group	exercise	-
HV night splint (SP) group	hallux valgus night splint	-

Primary Outcome Measures

Name	Time	Method
change in Manchester-Oxford Foot Questionnaire score	were assessed three times: before enrollment, at 1st and 3rd months.	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
Manchester Scale	used once before enrollment for the inclusion	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	were taken before enrollment and at three-month follow-up controls	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.