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Efficacy of Splinting, Exercise and Electrotherapy on Hallux Valgus

A

Ankara Yildirim Beyazıt University

Status

Completed

Conditions

Hallux Valgus

Treatments

Other: exercise
Device: hallux valgus night splint
Other: Electrotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT04393545
KA08/143

Details and patient eligibility

About

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).

Enrollment

60 patients

Sex

Female

Ages

18 to 60 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

60 participants in 3 patient groups

HV night splint (SP) group
Active Comparator group
Treatment:
Device: hallux valgus night splint
exercise (EX) group
Active Comparator group
Treatment:
Other: exercise
high-voltage galvanic stimulation (EL) group
Active Comparator group
Treatment:
Other: Electrotherapy

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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