Effects of Postoperative Kinesio Taping in Weber Type B Lateral Malleolar Fractures (KT-WeberB)

May 3, 2025 updated by: Fatih Sultan Mehmet Training and Research Hospital

The Effects of Postoperative Kinesio Taping on Pain, Range of Motion, and Edema in Weber Type B Lateral Malleolar Fractures: A Randomized Controlled Trial

This randomized controlled trial aimed to evaluate the effects of postoperative Kinesio taping on pain, range of motion, and edema in patients undergoing surgical fixation for Weber type B lateral malleolar fractures.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients with Weber type B lateral malleolar fractures treated surgically were randomized into two groups: a control group receiving standard rehabilitation and an intervention group receiving additional Kinesio taping. Outcomes assessed included visual analog scale (VAS) pain scores, dorsiflexion range of motion, and circumferential edema measurements at 1, 7, and 28 days postoperatively.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Ataşehir
      • Istanbul, Ataşehir, Turkey, 34752
        • Fatih Sultan Mehmet Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age between 18 and 65 years
  • Patients diagnosed with isolated Weber type B lateral malleolar fractures requiring surgical fixation
  • Surgery performed within 7 days of injury
  • Written informed consent provided

Exclusion Criteria:

  • Open fractures
  • Associated fractures of the medial or posterior malleolus requiring fixation
  • Polytrauma patients
  • History of previous ankle fractures or surgeries on the affected side
  • Neurological or vascular compromise of the affected limb
  • Known allergy to adhesive materials

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control Group
Standard postoperative rehabilitation without Kinesio taping.
Other: Standard Postoperative Rehabilitation
Standard rehabilitation protocol after surgical fixation of Weber type B ankle fractures without Kinesio taping.
Other: Kinesio Taping Group
Standard postoperative rehabilitation plus Kinesio taping application.
Other: Standard Postoperative Rehabilitation
Standard rehabilitation protocol after surgical fixation of Weber type B ankle fractures without Kinesio taping.
Other: Kinesio Taping
Kinesio taping applied over the surgical ankle to assist in reducing postoperative pain, swelling, and improving range of motion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pain levels assessed by Visual Analog Scale (VAS) at 4 weeks postoperatively
Time Frame: 28 days
VAS scores ranging from 0 (no pain) to 10 (worst pain) measured at postoperative day 1, day 7, and day 28.
28 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in ankle dorsiflexion range of motion at 4 weeks, measured in degrees using a goniometer.
Time Frame: 28 days
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fatih Sultan Mehmet Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 25, 2024

Primary Completion (Actual)

January 10, 2025

Study Completion (Actual)

March 20, 2025

Study Registration Dates

First Submitted

April 26, 2025

First Submitted That Met QC Criteria

May 3, 2025

First Posted (Actual)

May 6, 2025

Study Record Updates

Last Update Posted (Actual)

May 6, 2025

Last Update Submitted That Met QC Criteria

May 3, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KT-WeberB-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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