Trials / Completed
CompletedNCT04393545
Efficacy of Splinting, Exercise and Electrotherapy on Hallux Valgus
A Comparison of the Effectiveness of Splinting, Exercise and Electrotherapy in the Management of Hallux Valgus: a Randomized Clinical Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Ankara Yildirim Beyazıt University · Academic / Other
- Sex
- Female
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | 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. |
| OTHER | exercise | The exercises involved strengthening the AbdH (abductor hallucis) and plantar fascia muscles, and stretching the hallux |
| 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. |
Timeline
- Start date
- 2009-02-02
- Primary completion
- 2014-07-07
- Completion
- 2014-11-03
- First posted
- 2020-05-19
- Last updated
- 2020-05-19
Source: ClinicalTrials.gov record NCT04393545. Inclusion in this directory is not an endorsement.