Metatarsophalangeal Joint Sprain Kinesiotaping

August 5, 2023 updated by: Maged Basha, Qassim University

Kinesiology Taping Helps Patients With First Metatarsophalangeal Joint Sprain

kinesio taping would reduce pain, improve gait performance, and enhance the functional capacity of turf toe patients undergoing physical therapy

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

Health practitioners have recently become interested in using kinesiology taping in clinical practice as an alternative to traditional taping and bracing procedures for treating a variety of diseases, including sprain of metatarsophalangeal joint of the big toe. Patients with turf toe can benefit from kinesiology tape because it offers therapeutic support and stability while preserving a normal range of motion.

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.
60

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

  • Saudi Arabia
    • Riyadh
      • Al-Kharj, Riyadh, Saudi Arabia
        • King Khalid Hospital
      • Al-Kharj, Riyadh, Saudi Arabia, 11432
        • Outpatient Clinic of College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • comprised athletes with 2nd grade turf toe.
  • medically stable.
  • had foot pain for more than a month prior to enrollment.
  • didn't have persistent, incapacitating pain.
  • had a doctor's note approving their decision to stop taking painkillers during the research.

Exclusion Criteria:

  • if they had any surgical intervention before.
  • range of motion limitation in the ankle joint.
  • inability to exercise.
  • systemic disease.
  • any other orthopedic problem at ankle joints.

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: Single

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: exercise group
60-minutes exercise program, three times a week on alternate days for 12 successive weeks.
Other: Traditional physical therapy program
60-minutes exercise program, three times a week on alternate days for 12 successive weeks
Other Names:
  • exercise program
Experimental: placebo kinesiology taping plus exercise group
Kinesiology taping was used, however the strain was zero. Before each exercise session, the tape was changed every two days while the patients were present.
Other: Traditional physical therapy program
60-minutes exercise program, three times a week on alternate days for 12 successive weeks
Other Names:
  • exercise program
Other: placebo Kinsio taping
One full strip of kinesiology taping tape and one half-length strip were needed for the placebo kinesiology taping application
Other Names:
  • placebo kinesiology taping
Experimental: kinesiology taping plus exercise group
putting no stress on the opposite end and a 50% stretch from the top of the big toe to the heel along the back of the heel. After applying a 50% stretch from the top of the big toe to the second horizontal little strip between the big toe and second toe, place the ends below the toe diagonally with no stress.
Other: Traditional physical therapy program
60-minutes exercise program, three times a week on alternate days for 12 successive weeks
Other Names:
  • exercise program
Other: Kinsio taping
One full strip of kinesiology taping tape and one half-length strip were needed for the kinesiology taping application
Other Names:
  • kinesiology taping

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
Pain visual analog scale
Time Frame: at first week
The degree of the pain was assessed using a 10-cm visual analog scale (VAS), with 0 denoting no pain and 10 denoting the most painful event.
at first week
Pain visual analog scale
Time Frame: after 12 weeks
The degree of the pain was assessed using a 10-cm visual analog scale (VAS), with 0 denoting no pain and 10 denoting the most painful event.
after 12 weeks
Gait parameters (step length by centimeter).
Time Frame: at first week
The twelve computerized cameras of the VICON 3D motion analysis system were used to record gait data.
at first week
Gait parameters (step length by centimeter).
Time Frame: after 12 weeks
The twelve computerized cameras of the VICON 3D motion analysis system were used to record gait data.
after 12 weeks
Gait parameters (stride length by meter).
Time Frame: at first week
The twelve computerized cameras of the VICON 3D motion analysis system were used to record gait data.
at first week
Gait parameters (stride length by meter).
Time Frame: after 12 weeks
The twelve computerized cameras of the VICON 3D motion analysis system were used to record gait data.
after 12 weeks
Gait parameters (cadence by steps per minute).
Time Frame: at first week
The twelve computerized cameras of the VICON 3D motion analysis system were used to record gait data.
at first week
Gait parameters (cadence by steps per minute).
Time Frame: after 12 weeks
The twelve computerized cameras of the VICON 3D motion analysis system were used to record gait data.
after 12 weeks
Gait parameters (velocity by centimeter per second).
Time Frame: at first week
The twelve computerized cameras of the VICON 3D motion analysis system were used to record gait data.
at first week
Gait parameters (velocity by centimeter per second).
Time Frame: after 12 weeks
The twelve computerized cameras of the VICON 3D motion analysis system were used to record gait data.
after 12 weeks

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
Functional ability assessment
Time Frame: at first week
Functional ability was assessed using the 6-minute walk test.
at first week
Functional ability assessment
Time Frame: after 12 weeks
Functional ability was assessed using the 6-minute walk test.
after 12 weeks

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.
Qassim University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Cairo University
Prince Sattam Bin Abdulaziz University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alshimaa Azab, PhD, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 10, 2021

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.
August 22, 2022

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 15, 2023

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).
July 10, 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.
August 5, 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.
August 8, 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.
August 8, 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.
August 5, 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.
August 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.
  • RHPT/0021/0063

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

IPD Sharing Time Frame

6 months after publication

IPD Sharing Access Criteria

relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

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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