Kineesiotaping for Patients With LCPD

April 21, 2023 updated by: Sezen Karaborklu Argut, Istanbul University - Cerrahpasa (IUC)

Effects of Kinesiotaping in Patients With Legg-Calvé-Perthes Disease: A Randomized, Double-blind, Placebo-controlled Trial

Kinesiotaping is increasingly being used as a complement to musculoskeletal pain management. This study aimed to evaluate the immediate clinical efficacy of kinesiotaping on pain and pain-related symptoms of Legg-Calvé-Perthes Disease (LCPD).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Kinesio taping is increasingly being used as a complement to musculoskeletal pain management. A randomized, double-blind, placebo-controlled clinical trial was conducted. Activity-related hip pain, passive and pain limited hip range of motion, gluteus medius muscle strength, function and balance were assessed.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
      • Istanbul, Turkey
        • Istanbul University-Cerrahpaşa

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Having received unilateral LCPD diagnosis,
  • Anterior hip pain minimum three points on 10-cm Visual Analog Scale (VAS) over the previous week,
  • Having the following symptoms; weakness of gluteus medius muscle and patient-reported complaints on function or balance

Exclusion Criteria:

  • Having a history of any other hip pathologies,
  • Having allergy to polyacrylate adhesive,
  • Having used analgesic medication within the previous three days.

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: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Kinesiotaping group
Kinesiotape was applied to the lateral side of the affected hip for gluteus medius muscle. Each patient was positioned lying down with the affected side up, and two I-strips were used.
Other: Kinesiotaping

Two I-strips were used:

  1. The first-third of one I-strip began at the posterior iliac crest, without tension as an anchor. Then the patient actively flexed and adducted the affected hip, thus, the middle-third of the tape was applied with approximately 50% tension. Then the hip was set in its original position and the last-third of the tape ended approximately greater trochanter without tension.
  2. The first-third of the second I-strip was applied starting at the anterior iliac crest, without tension as an anchor. The patient actively extended and adducted the affected hip, thus, the middle-third of the tape was applied with approximately 50% tension. Then the hip was set in its original position and the last-third of the tape ended approximately greater trochanter without tension.
Sham Comparator: Sham taping group
Sham tape was applied with a single I-strip without tension in tape or muscle stretch. After paper backing was completely removed, tape was essentially placed on the skin across the lateral side of the affected hip.
Other: Sham taping
A single I-strip without tension in tape or muscle stretch. After paper backing was completely removed, tape was essentially placed on the skin across the lateral side of the hip.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Immediate Clinical Efficacy on Activity Related Hip
Time Frame: The change between T1 (baseline) to T2 (thirty minutes later from the application)
Horizontal 10 cm VAS (0, no pain; 10, the worst pain ever possible)
The change between T1 (baseline) to T2 (thirty minutes later from the application)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Immediate Clinical Efficacy on Hip Abduction ROM
Time Frame: The change between T1 (baseline) to T2 (thirty minutes later from the application)
goniometric range of motion (ROM)
The change between T1 (baseline) to T2 (thirty minutes later from the application)
Immediate Clinical Efficacy on Functional Task Durations
Time Frame: The change between T1 (baseline) to T2 (thirty minutes later from the application)
10-meters walk task duration (sec) and 10-step climbing task duration (sec)
The change between T1 (baseline) to T2 (thirty minutes later from the application)
Immediate Clinical Efficacy on Balance test durations
Time Frame: The change between T1 (baseline) to T2 (thirty minutes later from the application)
One leg stance test duration (sec) and Tandem walk test duration (sec)
The change between T1 (baseline) to T2 (thirty minutes later from the application)
Immediate Clinical Efficacy on Gluteus medius muscle strength
Time Frame: The change between T1 (baseline) to T2 (thirty minutes later from the application)
muscle strength by handheld dynamometer (Ibs)
The change between T1 (baseline) to T2 (thirty minutes later from the application)

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul University - Cerrahpasa (IUC)

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 25, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 6, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 11, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 20, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 3, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 3, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20151704-1746

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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