Effects of Hallux Valgus Deformity on Rear Foot Position, Pain, Function, and Quality of Life in Women

November 14, 2013 updated by: Gursoy Coskun, Hacettepe University
To investigate relationship between HV deformity and position of rearfoot joints, and its effects on the quality of life, pain, and related functional status in women with bilateral hallux valgus (HV).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

To investigate relationship between HV deformity and position of rearfoot joints, and its effects on the quality of life, pain, and related functional status in women with bilateral hallux valgus (HV). Study included 27 right-dominant women. Demographic data, HV angle, weight-bearing and non-weight-bearing subtalar pronation (SP), and navicular height were recorded. Visual Analog Scale, Foot Function Index (FFI), and the American Orthopaedic Foot and Ankle Society (AOFAS) MTP-IP along with AOFAS Mid foot (MF) Scales, and SF-36 were used. HV angle, weight-bearing SP, and pain intensity of the left foot were higher. HV angle of left foot was correlated with all sub-sections of FFI, pain parameter of AOFAS MTP-IP, and pain and total score of AOFAS-MF Scale ). HV angle of left foot was correlated with physical role, pain, and social function sub-domains of SF-36. Right HV angles were correlated with right foot pain and non-weight-bearing SP.Increasing HV angle and pathomechanical changes in rear foot were correlated. Besides, although all participants were right-dominant, their left foot problems were more highlighted.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
27

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Effects of hallux valgus deformity in women

Description

Inclusion Criteria:Inclusion criteria were as follows:

  • Women in an age range of 18-55 years,
  • Having bilateral deformity with right-dominance,
  • First MTP angle of > 15° as radiologically determined by the referring physician,
  • Deformity intensity > 2 based on the Manchester scale,
  • Muscle forces on ankle and foot > 4
  • Having no systemic disease that affects foot biomechanics with no history of surgery,
  • Having no neurological problems,
  • Having no cognitive, mental, or psychological problems.

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Hallux valgus patients
Females patients with hallux valgus asses for pain, function, and quality of life

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain
Time Frame: baseline
Pain was measured using by Visual Analog Scale
baseline
AOFAS Mid foot (MF) Scales
Time Frame: baseline
baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
HV angle and navicular height
Time Frame: baseline
HV angle was measured by using Universal Goniometers
baseline

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Foot Function Index
Time Frame: baseline
Using the Foot Function Index
baseline
American Orthopaedic Foot and Ankle Society (AOFAS)MTP-IP
Time Frame: baseline
baseline
weight-bearing and non-weight-bearing subtalar pronation (SP)
Time Frame: baseline
baseline
SF-36
Time Frame: baseline
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hacettepe University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Burcu TALU, PT. MSc, İnönü University, School of Malatya Health, Department of Physiotherapy and Rehabilitation
  • Principal Investigator: Gürsoy COŞKUN, PT. PhD., Hacettepe University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Ankara, TURKEY
  • Study Chair: Nilgün BEK, PT. PhD., Hacettepe University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Ankara, TURKEY
  • Study Chair: Kezban BAYRAMLAR, PT. PhD, Hacettepe University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Ankara, TURKEY

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2012

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 11, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 21, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 21, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LUT09/37-26

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