Efficacy of Splinting, Exercise and Electrotherapy on Hallux Valgus

NCT04393545 | Completed

• 1 other identifier: KA08/143
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Hallux Valgus

Keywords

hallux valgus; Night splint; Exercise; High voltage galvanic stimulation; Radiographic angular degree; Foot-specific health-related quality of life

Outcome Measures

Primary Outcomes (3)

• Manchester Scale

  This scale determines the severity of HV and deformity using four foot photographs (0 'no deformity', 1 'mild', 2 'moderate' or 3: 'severe deformity').

  used once before enrollment for the inclusion

• change in hallux valgus angle

  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.

  were taken before enrollment and at three-month follow-up controls

• change in Manchester-Oxford Foot Questionnaire score

  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

  were assessed three times: before enrollment, at 1st and 3rd months.

Study Arms (3)

HV night splint (SP) group

ACTIVE COMPARATOR

Device: hallux valgus night splint

exercise (EX) group

ACTIVE COMPARATOR

Other: exercise

high-voltage galvanic stimulation (EL) group

ACTIVE COMPARATOR

Other: Electrotherapy

Interventions

hallux valgus night splint 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.

HV night splint (SP) group

exercise OTHER

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

exercise (EX) group

Electrotherapy 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.

high-voltage galvanic stimulation (EL) group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara Yildirim Beyazıt University: lead

Related Publications (1)

• 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.

  PMID: 34388424 DERIVED

MeSH Terms

Conditions

Hallux Valgus; Motor Activity

Interventions

Exercise; Electric Stimulation Therapy

Condition Hierarchy (Ancestors)

Foot Deformities; Musculoskeletal Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSOCIATE PROFESSOR

Study Record Dates

• First Submitted: May 13, 2020
• First Posted: May 19, 2020
• Study Start: February 2, 2009
• Primary Completion: July 7, 2014
• Study Completion: November 3, 2014
• Last Updated: May 19, 2020

Record last verified: 2020-05