Hallux ValgusNCT01989338
Effects of Hallux Valgus Deformity on Rear Foot Position, Pain, Function, and Quality of Life in Women
An observational study of Hallux Valgus and Pain, run by Hacettepe University.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hallux Valgus, Pain
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- Mar 2012to Feb 2013
- Phase
- Observational
- 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 55 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Effects of hallux valgus deformity in women
Who may be able to join
- 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.
Who cannot join
- -
About this study
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).
Read the 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.
- Conditions
- Hallux Valgus, Pain
- Keywords
- hallux valgus, pain, functional status, quality of life
- Medical subject headings
- Hallux Valgus, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hallux valgus patients | Females patients with hallux valgus asses for pain, function, and quality of life |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Pain was measured using by Visual Analog Scale
Measured: baseline
AOFAS Mid foot (MF) Scales
Measured: baseline
Secondary outcomes (1)
HV angle and navicular height
HV angle was measured by using Universal Goniometers
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2013 (estimated)
- Study startMar 2012
- Primary completionSep 2012
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (44)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 Hacettepe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gursoy Coskun, Hacettepe University
- Investigators
- Burcu TALU, PT. MSc, Study director, İnönü University, School of Malatya Health, Department of Physiotherapy and RehabilitationGürsoy COŞKUN, PT. PhD., Principal investigator, Hacettepe University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Ankara, TURKEYNilgün BEK, PT. PhD., Study chair, Hacettepe University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Ankara, TURKEYKezban BAYRAMLAR, PT. PhD, Study chair, Hacettepe University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Ankara, TURKEY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01989338
- Sponsor's protocol ID
- LUT09/37-26
- Status last verified
- Sep 2013
- First submitted
- 11 Oct 2013
- Last updated
- 21 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Coughlin MJ, Jones CP. Hallux valgus: demographics, etiology, and radiographic assessment. Foot Ankle Int. 2007 Jul;28(7):759-77. doi: 10.3113/FAI.2007.0759.
PubMed 17666168Bock P, Kristen KH, Kroner A, Engel A. Hallux valgus and cartilage degeneration in the first metatarsophalangeal joint. J Bone Joint Surg Br. 2004 Jul;86(5):669-73. doi: 10.1302/0301-620x.86b5.14766.
PubMed 15274261Robinson AH, Limbers JP. Modern concepts in the treatment of hallux valgus. J Bone Joint Surg Br. 2005 Aug;87(8):1038-45. doi: 10.1302/0301-620X.87B8.16467. No abstract available.
PubMed 16049235Menz HB, Lord SR. Foot problems, functional impairment, and falls in older people. J Am Podiatr Med Assoc. 1999 Sep;89(9):458-67. doi: 10.7547/87507315-89-9-458.
PubMed 10507214Coughlin MJ. Hallux valgus. J Bone Joint Surg Am. 1996 Jun;78(6):932-66. No abstract available.
PubMed 8666613Bek N, Kürklü B. Comparison of the effects of different conservative treatment methods in treatment of hallux valgus. [Halluks valgus tedavisinde kullanılan farklı konservatif yöntemlerin etkinliklerinin karşılaştırılması.] Article in Turkish. Artroplasti Artroskopik Cerrahi 2002;13:90-93.
Coughlin MJ. Hallux valgus. Causes, evaluation, and treatment. Postgrad Med. 1984 Apr;75(5):174-8, 183, 186-7. doi: 10.1080/00325481.1984.11698000. No abstract available.
PubMed 6709527Uchiyama E, Kitaoka HB, Luo ZP, Grande JP, Kura H, An KN. Pathomechanics of hallux valgus: biomechanical and immunohistochemical study. Foot Ankle Int. 2005 Sep;26(9):732-8. doi: 10.1177/107110070502600911.
PubMed 16174504Coughlin MJ, Thompson FM. The high price of high-fashion footwear. Instr Course Lect. 1995;44:371-7. No abstract available.
PubMed 7797875Roddy E, Zhang W, Doherty M. Prevalence and associations of hallux valgus in a primary care population. Arthritis Rheum. 2008 Jun 15;59(6):857-62. doi: 10.1002/art.23709.
PubMed 18512715Mann RA, Coughlin MJ. Hallux valgus--etiology, anatomy, treatment and surgical considerations. Clin Orthop Relat Res. 1981 Jun;(157):31-41.
PubMed 7249460Dawson J, Thorogood M, Marks SA, Juszczak E, Dodd C, Lavis G, Fitzpatrick R. The prevalence of foot problems in older women: a cause for concern. J Public Health Med. 2002 Jun;24(2):77-84. doi: 10.1093/pubmed/24.2.77.
PubMed 12141589SIM-FOOK L, HODGSON AR. A comparison of foot forms among the non-shoe and shoe-wearing Chinese population. J Bone Joint Surg Am. 1958 Oct;40-A(5):1058-62. No abstract available.
PubMed 13587573BARNICOT NA, HARDY RH. The position of the hallux in West Africans. J Anat. 1955 Jul;89(3):355-61. No abstract available.
PubMed 13251965Menz HB, Morris ME. Footwear characteristics and foot problems in older people. Gerontology. 2005 Sep-Oct;51(5):346-51. doi: 10.1159/000086373.
PubMed 16110238
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hallux Valgus Deformity on Rear Foot Position, Pain, Function, and Quality of Life in Women
- ClinicalTrials.gov ID
- NCT01989338
- Acronym / sponsor ID
- LUT09/37-26
- Conditions
- Hallux Valgus, Pain
- Keywords
- hallux valgus, pain, functional status, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 21 Nov 2013 (estimated)
- 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.
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).
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hallux valgus patients | – | –Females patients with hallux valgus asses for pain, function, and quality of life |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Effects of hallux valgus deformity in women
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain
Time frame: baseline
Pain was measured using by Visual Analog Scale
AOFAS Mid foot (MF) Scales
Time frame: baseline
1 secondary outcome
HV angle and navicular height
Time frame: baseline
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 21 Nov 2013.
- Background: PubMed 17666168Coughlin MJ, Jones CP. Hallux valgus: demographics, etiology, and radiographic assessment. Foot Ankle Int. 2007 Jul;28(7):759-77. doi: 10.3113/FAI.2007.0759.
- Background: PubMed 15274261Bock P, Kristen KH, Kroner A, Engel A. Hallux valgus and cartilage degeneration in the first metatarsophalangeal joint. J Bone Joint Surg Br. 2004 Jul;86(5):669-73. doi: 10.1302/0301-620x.86b5.14766.
- Background: PubMed 16049235Robinson AH, Limbers JP. Modern concepts in the treatment of hallux valgus. J Bone Joint Surg Br. 2005 Aug;87(8):1038-45. doi: 10.1302/0301-620X.87B8.16467. No abstract available.
- Background: PubMed 10507214Menz HB, Lord SR. Foot problems, functional impairment, and falls in older people. J Am Podiatr Med Assoc. 1999 Sep;89(9):458-67. doi: 10.7547/87507315-89-9-458.
- Background: PubMed 8666613Coughlin MJ. Hallux valgus. J Bone Joint Surg Am. 1996 Jun;78(6):932-66. No abstract available.
- BackgroundBek N, Kürklü B. Comparison of the effects of different conservative treatment methods in treatment of hallux valgus. [Halluks valgus tedavisinde kullanılan farklı konservatif yöntemlerin etkinliklerinin karşılaştırılması.] Article in Turkish. Artroplasti Artroskopik Cerrahi 2002;13:90-93.
- Background: PubMed 6709527Coughlin MJ. Hallux valgus. Causes, evaluation, and treatment. Postgrad Med. 1984 Apr;75(5):174-8, 183, 186-7. doi: 10.1080/00325481.1984.11698000. No abstract available.
- Background: PubMed 16174504Uchiyama E, Kitaoka HB, Luo ZP, Grande JP, Kura H, An KN. Pathomechanics of hallux valgus: biomechanical and immunohistochemical study. Foot Ankle Int. 2005 Sep;26(9):732-8. doi: 10.1177/107110070502600911.
- Background: PubMed 7797875Coughlin MJ, Thompson FM. The high price of high-fashion footwear. Instr Course Lect. 1995;44:371-7. No abstract available.
- Background: PubMed 18512715Roddy E, Zhang W, Doherty M. Prevalence and associations of hallux valgus in a primary care population. Arthritis Rheum. 2008 Jun 15;59(6):857-62. doi: 10.1002/art.23709.
- Background: PubMed 7249460Mann RA, Coughlin MJ. Hallux valgus--etiology, anatomy, treatment and surgical considerations. Clin Orthop Relat Res. 1981 Jun;(157):31-41.
- Background: PubMed 12141589Dawson J, Thorogood M, Marks SA, Juszczak E, Dodd C, Lavis G, Fitzpatrick R. The prevalence of foot problems in older women: a cause for concern. J Public Health Med. 2002 Jun;24(2):77-84. doi: 10.1093/pubmed/24.2.77.
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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.
Burcu TALU, PT. MSc study director
İnönü University, School of Malatya Health, Department of Physiotherapy and Rehabilitation
Gürsoy COŞKUN, PT. PhD. principal investigator
Hacettepe University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Ankara, TURKEY
Nilgün BEK, PT. PhD. study chair
Hacettepe University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Ankara, TURKEY
Questions about this trial
What is this clinical trial studying?
An observational study of Hallux Valgus and Pain, run by Hacettepe 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 8 inclusion and 1 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 21 Nov 2013. 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?
Pain (time frame: baseline). The study lists 2 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 NCT01989338, which also lists 44 linked publications.
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 21 Nov 2013.