Efficacy of Splinting, Exercise and Electrotherapy on Hallux Valgus

NCT ID: NCT04393545

Last Updated: 2020-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-02

Study Completion Date

2014-11-03

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).

Detailed Description

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Conditions

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Hallux Valgus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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HV night splint (SP) group

Group Type ACTIVE_COMPARATOR

hallux valgus night splint

Intervention Type DEVICE

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.

exercise (EX) group

Group Type ACTIVE_COMPARATOR

exercise

Intervention Type OTHER

The exercises involved strengthening the AbdH (abductor hallucis) and plantar fascia muscles, and stretching the hallux

high-voltage galvanic stimulation (EL) group

Group Type ACTIVE_COMPARATOR

Electrotherapy

Intervention Type OTHER

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.

Interventions

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hallux valgus night splint

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 DEVICE

exercise

The exercises involved strengthening the AbdH (abductor hallucis) and plantar fascia muscles, and stretching the hallux

Intervention Type OTHER

Electrotherapy

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.

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ankara Yildirim Beyazıt University

OTHER

Sponsor Role lead

Responsible Party

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Bahar Anaforoglu Külünkoglu

ASSOCIATE PROFESSOR

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type DERIVED
PMID: 34388424 (View on PubMed)

Other Identifiers

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KA08/143

Identifier Type: -

Identifier Source: org_study_id

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