Trial Outcomes & Findings for Initial Effects of Kinesiotaping in Non Surgical Treatment of Hallux Valgus (NCT NCT01952691)

Results Overview

X ray was obtained in non-weight bearing sitting position. It's aimed to see the treatment effects kinesio taping

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

22 participants

Primary outcome timeframe

up to 30 days after the treatment

Results posted on

2016-03-14

Participant Flow

Participant milestones

Participant milestones
Measure	Kinesiotaping Implementation kinesiotaping was implemetedto all patients to align the hallux to correct position for 10 days. Each patient was re-assessed and the taping implementation was renewed on the 3rd, 7th and 10th days of the treatment. kinesiotaping: correction method was used to align hallux's adduction position.
Overall Study STARTED	22
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Kinesiotaping Implementation kinesiotaping was implemetedto all patients to align the hallux to correct position for 10 days. Each patient was re-assessed and the taping implementation was renewed on the 3rd, 7th and 10th days of the treatment. kinesiotaping: correction method was used to align hallux's adduction position.
Overall Study Lost to Follow-up	2

Baseline Characteristics

Initial Effects of Kinesiotaping in Non Surgical Treatment of Hallux Valgus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Kinesiotaping n=22 Participants all patients were implemented a kinesiotaping to align the hallux to correct position kinesiotaping: correction method was used to align hallux.
Age, Continuous	43.3 years STANDARD_DEVIATION 13.3 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to 30 days after the treatment

Population: 35 feet's X Ray results were obtained from 22 patients before treatment protocol was performed.

X ray was obtained in non-weight bearing sitting position. It's aimed to see the treatment effects kinesio taping

Outcome measures

Outcome measures
Measure	Kinesiotaping Implementation n=35 feet kinesiotaping was implemetedto all patients to align the hallux to correct position for 10 days. Each patient was re-assessed and the taping implementation was renewed on the 3rd, 7th and 10th days of the treatment. kinesiotaping: correction method was used to align hallux's adduction position.
Adduction Angle of Hallux With X RAY before treatment protocol	22.6 degrees Standard Deviation 5.0
Adduction Angle of Hallux With X RAY after treatment was ceased	19.3 degrees Standard Deviation 5.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Kinesiotaping Implementation n=35 feet kinesiotaping was implemetedto all patients to align the hallux to correct position for 10 days. Each patient was re-assessed and the taping implementation was renewed on the 3rd, 7th and 10th days of the treatment. kinesiotaping: correction method was used to align hallux's adduction position.
FFI before treatment protocol	3.2 units on a scale Standard Deviation 1.6
FFI after treatment was ceased (30th day)	0.84 units on a scale Standard Deviation 1.24

SECONDARY outcome

Timeframe: baseline and 30th days.

we aimed to see the change in hallux valgus angle during treatment.

Outcome measures

Outcome measures
Measure	Kinesiotaping Implementation n=35 feet kinesiotaping was implemetedto all patients to align the hallux to correct position for 10 days. Each patient was re-assessed and the taping implementation was renewed on the 3rd, 7th and 10th days of the treatment. kinesiotaping: correction method was used to align hallux's adduction position.
Adduction Angle before treatment protocol	20.2 degrees Standard Deviation 4.7
Adduction Angle after treatment was ceased (30th day)	14.3 degrees Standard Deviation 5.0

Adverse Events

Kinesiotaping Implementation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Gul Oznur Karabicak

Hacettepe University

Phone: +90 505 3569409

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place