Hallux ValgusNCT04393545
Efficacy of Splinting, Exercise and Electrotherapy on Hallux Valgus
A study testing hallux valgus night splint, exercise and Electrotherapy in people with Hallux Valgus, run by Ankara Yildirim Beyazıt University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Hallux Valgus
- What is being tested?
- hallux valgus night splint, exercise and Electrotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 2 Feb 2009to 3 Nov 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: A Comparison of the Effectiveness of Splinting, Exercise and Electrotherapy in the Management of Hallux Valgus: a Randomized Clinical Trial
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
- Being tested
- hallux valgus night splint, exercise, Electrotherapy
- Keywords
- hallux valgus, Night splint, Exercise, High voltage galvanic stimulation, Radiographic angular degree, Foot-specific health-related quality of life
- Medical subject headings
- Hallux Valgus, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hallux valgus night splintDevice
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.
exerciseOther
The exercises involved strengthening the AbdH (abductor hallucis) and plantar fascia muscles, and stretching the hallux
ElectrotherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| HV night splint (SP) group | Active comparator | Not described Receives: Device: hallux valgus night splint |
| exercise (EX) group | Active comparator | Not described Receives: Other: exercise |
| high-voltage galvanic stimulation (EL) group | Active comparator | Not described Receives: Other: Electrotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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').
Measured: 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.
Measured: 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
Measured: were assessed three times: before enrollment, at 1st and 3rd months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start2 Feb 2009
- Primary completion7 Jul 2014
- Study completion3 Nov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hallux ValgusStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bahar Anaforoglu Külünkoglu, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04393545
- Sponsor's protocol ID
- KA08/143
- Status last verified
- May 2020
- First submitted
- 13 May 2020
- Last updated
- 19 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34388424
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Effectiveness of Splinting, Exercise and Electrotherapy in the Management of Hallux Valgus: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04393545
- Acronym / sponsor ID
- KA08/143
- Conditions
- Hallux Valgus
- Keywords
- hallux valgus, Night splint, Exercise, High voltage galvanic stimulation, Radiographic angular degree, Foot-specific health-related quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 2 Feb 2009 (actual)
- Primary completion
- 7 Jul 2014 (actual)
- Study completion
- 3 Nov 2014 (actual)
- First posted
- 19 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hallux valgus night splintThe 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. | Device | HV night splint (SP) group |
| exerciseThe exercises involved strengthening the AbdH (abductor hallucis) and plantar fascia muscles, and stretching the hallux | Other | exercise (EX) group |
| ElectrotherapyTwo 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. | Other | high-voltage galvanic stimulation (EL) group |
Primary outcome
Manchester Scale
Time frame: 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
Time frame: 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
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
- Derived from this study: PubMed 34388424Kulunkoglu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing hallux valgus night splint, exercise and Electrotherapy in people with Hallux Valgus, run by Ankara Yildirim Beyazıt University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Manchester Scale (time frame: used once before enrollment for the inclusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04393545, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2020.