Initial Effects of Kinesiotaping in Non Surgical Treatment of Hallux Valgus

Pain Clinical Trial

Official title:

Initial Effects of Kinesiotaping in Conservative Treatment of Hallux Valgus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01952691
• Other study ID #: HEK 10/58-48
• Status: Completed
• Phase: N/A
• First received: September 19, 2013
• Last updated: February 18, 2016
• Start date: March 2011
• Est. completion date: October 2011

Study information

• Verified date: April 2015
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hallux Valgus
• Pain

Intervention

Device:
• kinesiotaping
correction method was used to align hallux.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	up to 30 days after the treatment	No
Secondary	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.	baseline, on the 3rd, 7th, 10th and 30th days during the treatment	No
Secondary	Adduction Angle	we aimed to see the change in hallux valgus angle during treatment.	baseline and 30th days.	No