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Initial Effects of Kinesiotaping in Non Surgical Treatment of Hallux Valgus

Primary Purpose

Hallux Valgus, Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
kinesiotaping
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hallux Valgus focused on measuring hallux valgus, pain, conservative, treatment

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Hallux adduction angle between 15-40º
  • Pain intensity higher than 5 according to VAS
  • 20- 45 years age female
  • No trauma, surgery history
  • Surgery is indicated but the patient is willing to try conservative treatment options

Exclusion Criteria:

  • Fracture, surgery history on the great toe
  • Systematic disease (Rheumatoid Arthritis, Systematic Lupus Erythematosus Diabetes)
  • Using NSAID, analgesic drug
  • Hallux rigidus diagnosis

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    kinesiotaping

    Arm Description

    all patients were implemented a kinesiotaping to align the hallux to correct position

    Outcomes

    Primary Outcome Measures

    Adduction Angle of Hallux With X RAY
    X ray was obtained in non-weight bearing sitting position. It's aimed to see the treatment effects kinesio taping

    Secondary Outcome Measures

    FFI
    We aimed to see the change in functional status with FFI (Foot function index) scale The FFI is a self-administered index consisting of 23 items divided into 3 sub-scales used to score each question on a scale from 0 (no pain or difficulty) to 10 (worst pain imaginable or so difficult it required help) that best describes the patients' foot over the past week. Patients were instructed to mark a VAS score for each question. The total score was calculated using only the questions answered.
    Adduction Angle
    we aimed to see the change in hallux valgus angle during treatment.

    Full Information

    First Posted
    September 19, 2013
    Last Updated
    February 18, 2016
    Sponsor
    Hacettepe University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01952691
    Brief Title
    Initial Effects of Kinesiotaping in Non Surgical Treatment of Hallux Valgus
    Official Title
    Initial Effects of Kinesiotaping in Conservative Treatment of Hallux Valgus
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2011 (undefined)
    Primary Completion Date
    October 2011 (Actual)
    Study Completion Date
    October 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hacettepe University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The main aim of this study was to find the initial effects of kinesiotaping on pain and joint alignment used in the conservative treatment of hallux valgus. 22 female patients diagnosed with hallux valgus participated in this study. Kinesiotaping was implemented after the first assessment and renewed in the 3rd, 7th and 10th days. The main outcome measures were the pain hallux adduction angle. Kinesiotaping may be an effective treatment option in decreasing pain and deformity in hallux valgus deformity who are conservatively treated. In future studies this method might be shown in larger sample groups at longer periods of treatment comparing with alternative treatment approaches like exercise or orthotics.
    Detailed Description
    Hallux valgus is a common pathologic entity affecting the great toe. Taping is an alternative method used to treat hallux valgus. The main aim of this study was to find the initial effects of kinesiotaping on pain and joint alignment used in the conservative treatment of hallux valgus. 22 female patients diagnosed with 13 bilateral, 7 right, 2 left totally 35 with hallux valgus participated in this study. Kinesiotaping was implemented after the first assessment and renewed in the 3rd, 7th and 10th days. The main outcome measures were the change in pain was assessed by using Visual Analogue Scale (VAS) and hallux adduction angle was measured by the universal goniometry. Secondary outcome measures were Patients' functional status was measured by Foot Function Index (FFI) and AOFAS. The plain radiographic results were also measured before and after 1-month of treatment. Pain and disability was controlled by KinesioTape® implementation in patients with hallux valgus. Kinesiotaping may be an effective treatment option in decreasing pain and deformity in hallux valgus deformity who are conservatively treated. In future studies this method might be shown in larger sample groups at longer periods of treatment comparing with alternative treatment approaches like exercise or orthotics.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hallux Valgus, Pain
    Keywords
    hallux valgus, pain, conservative, treatment

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    22 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    kinesiotaping
    Arm Type
    Experimental
    Arm Description
    all patients were implemented a kinesiotaping to align the hallux to correct position
    Intervention Type
    Device
    Intervention Name(s)
    kinesiotaping
    Intervention Description
    correction method was used to align hallux.
    Primary Outcome Measure Information:
    Title
    Adduction Angle of Hallux With X RAY
    Description
    X ray was obtained in non-weight bearing sitting position. It's aimed to see the treatment effects kinesio taping
    Time Frame
    up to 30 days after the treatment
    Secondary Outcome Measure Information:
    Title
    FFI
    Description
    We aimed to see the change in functional status with FFI (Foot function index) scale The FFI is a self-administered index consisting of 23 items divided into 3 sub-scales used to score each question on a scale from 0 (no pain or difficulty) to 10 (worst pain imaginable or so difficult it required help) that best describes the patients' foot over the past week. Patients were instructed to mark a VAS score for each question. The total score was calculated using only the questions answered.
    Time Frame
    baseline, on the 3rd, 7th, 10th and 30th days during the treatment
    Title
    Adduction Angle
    Description
    we aimed to see the change in hallux valgus angle during treatment.
    Time Frame
    baseline and 30th days.

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Hallux adduction angle between 15-40º Pain intensity higher than 5 according to VAS 20- 45 years age female No trauma, surgery history Surgery is indicated but the patient is willing to try conservative treatment options Exclusion Criteria: Fracture, surgery history on the great toe Systematic disease (Rheumatoid Arthritis, Systematic Lupus Erythematosus Diabetes) Using NSAID, analgesic drug Hallux rigidus diagnosis
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    nilgun bek, Phd PT
    Organizational Affiliation
    Hacettepe University
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Ugur TIFTIKCI, MD
    Organizational Affiliation
    beypazari hospital
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Gul Oznur KARABICAK, MS PT
    Organizational Affiliation
    Hacettepe University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Initial Effects of Kinesiotaping in Non Surgical Treatment of Hallux Valgus

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