NCT01952691

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2011

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 19, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 30, 2013

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

April 6, 2015

Completed
Last Updated

March 14, 2016

Status Verified

April 1, 2015

Enrollment Period

7 months

First QC Date

September 19, 2013

Results QC Date

March 25, 2015

Last Update Submit

February 18, 2016

Conditions

Keywords

hallux valguspainconservativetreatment

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • FFI

    baseline, on the 3rd, 7th, 10th and 30th days during the treatment

  • Adduction Angle

    baseline and 30th days.

Study Arms (1)

kinesiotaping

EXPERIMENTAL

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

Device: kinesiotaping

Interventions

correction method was used to align hallux.

kinesiotaping

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hallux ValgusPain

Condition Hierarchy (Ancestors)

Foot DeformitiesMusculoskeletal DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Gul Oznur Karabicak
Organization
Hacettepe University

Study Officials

  • nilgun bek, Phd PT

    Hacettepe University

    STUDY DIRECTOR
  • Ugur TIFTIKCI, MD

    beypazari hospital

    STUDY CHAIR
  • Gul Oznur KARABICAK, MS PT

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ms PT

Study Record Dates

First Submitted

September 19, 2013

First Posted

September 30, 2013

Study Start

March 1, 2011

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

March 14, 2016

Results First Posted

April 6, 2015

Record last verified: 2015-04