Efficacy of Splinting, Exercise and Electrotherapy on Hallux Valgus

Sponsor

Ankara Yildirim Beyazıt University (Other)

Overall Status

Completed

CT.gov ID

NCT04393545

Collaborator

(none)

Enrollment

Arms

Actual Duration (Months)

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Hallux Valgus	Device: hallux valgus night splint Other: exercise Other: Electrotherapy	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Comparison of the Effectiveness of Splinting, Exercise and Electrotherapy in the Management of Hallux Valgus: a Randomized Clinical Trial

Actual Study Start Date :

Feb 2, 2009

Actual Primary Completion Date :

Jul 7, 2014

Actual Study Completion Date :

Nov 3, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: HV night splint (SP) group	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.
Active Comparator: exercise (EX) group	Other: exercise The exercises involved strengthening the AbdH (abductor hallucis) and plantar fascia muscles, and stretching the hallux
Active Comparator: high-voltage galvanic stimulation (EL) group	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.

Arm

Intervention/Treatment

Active Comparator: HV night splint (SP) group

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.

Active Comparator: exercise (EX) group

Other: exercise

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

Active Comparator: high-voltage galvanic stimulation (EL) group

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.

Outcome Measures

Primary Outcome Measures

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.
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts 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.