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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01989338
• Other study ID #: LUT09/37-26
• Status: Completed
• Phase: N/A
• First received: October 11, 2013
• Last updated: November 14, 2013
• Start date: March 2012
• Est. completion date: February 2013

Study information

• Verified date: September 2013
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Observational

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: February 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hallux Valgus
• Pain

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

References & Publications (44)

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* Note: There are 44 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Foot Function Index	Using the Foot Function Index	baseline	No
Other	American Orthopaedic Foot and Ankle Society (AOFAS)MTP-IP		baseline	No
Other	weight-bearing and non-weight-bearing subtalar pronation (SP)		baseline	No
Other	SF-36		baseline	No
Primary	Pain	Pain was measured using by Visual Analog Scale	baseline	No
Primary	AOFAS Mid foot (MF) Scales		baseline	No
Secondary	HV angle and navicular height	HV angle was measured by using Universal Goniometers	baseline	No