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

Completed

Conditions

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

Observational

Enrollment (Actual)

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

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
Hallux valgus patients
Females patients with hallux valgus asses for pain, function, and quality of life

What is the study measuring?

Primary Outcome Measures

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

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

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

Hacettepe University

Investigators

  • 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

March 1, 2012

Primary Completion (ACTUAL)

September 1, 2012

Study Completion (ACTUAL)

February 1, 2013

Study Registration Dates

First Submitted

October 11, 2013

First Submitted That Met QC Criteria

November 14, 2013

First Posted (ESTIMATE)

November 21, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

November 21, 2013

Last Update Submitted That Met QC Criteria

November 14, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LUT09/37-26

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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