- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01952691
Initial Effects of Kinesiotaping in Non Surgical Treatment of Hallux Valgus
Initial Effects of Kinesiotaping in Conservative Treatment of 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 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.
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: kinesiotaping
all patients were implemented a kinesiotaping to align the hallux to correct position
|
correction method was used to align hallux.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adduction Angle of Hallux With X RAY
Time Frame: up to 30 days after the treatment
|
X ray was obtained in non-weight bearing sitting position.
It's aimed to see the treatment effects kinesio taping
|
up to 30 days after the treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
FFI
Time Frame: baseline, on the 3rd, 7th, 10th and 30th days during the treatment
|
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.
|
baseline, on the 3rd, 7th, 10th and 30th days during the treatment
|
|
Adduction Angle
Time Frame: baseline and 30th days.
|
we aimed to see the change in hallux valgus angle during treatment.
|
baseline and 30th days.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: nilgun bek, Phd PT, Hacettepe University
- Study Chair: Ugur TIFTIKCI, MD, beypazari hospital
- Principal Investigator: Gul Oznur KARABICAK, MS PT, Hacettepe University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HEK 10/58-48
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