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
About this trial
This is an interventional treatment trial for Hallux Valgus focused on measuring hallux valgus, pain, conservative, treatment
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
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
NCT ID
NCT01952691
First Posted
September 19, 2013
Last Updated
February 18, 2016
Sponsor
Hacettepe University
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
We'll reach out to this number within 24 hrs