Kinesiology Taping Technique in Post-mastectomy Breast Cancer Related Lymphedema

May 20, 2023 updated by: Dow University of Health Sciences

Effects of Kinesiology Taping Technique in Post-mastectomy Breast Cancer Related Lymphedema on Swelling, Upper Limb Function, and Strength

Generally, Breast cancer related to lymphedema is commonly found in the female population after mastectomy. It has many complications which affects the normal functions of an individual and quality of life. This randomized control trial will be conducted on patients who are admitted as patients after mastectomy to determine the effects of kinesiology taping technique in post mastectomy breast cancer related lymphedema on swelling, upper limb function and strength.

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

Generally, Breast cancer related to lymphedema is commonly found in the female population after mastectomy. It has many complications which affects the normal functions of an individual and quality of life. Traditional therapies like compression decongestive therapies and kinesiology taping techniques are used for the management of post mastectomy breast cancer related lymphedema.This randomized control trial will be conducted on patients who are admitted as patients after mastectomy to determine the effects of kinesiology taping technique in post mastectomy breast cancer related lymphedema on swelling, upper limb function and strength. Total 50 patients with post mastectomy who fulfill the inclusion criteria will be selected after taking consent. The subjects will be allocated into two groups through simple random sampling. Subjects ingroup A will be given kinesiology taping technique and exercise therapy whereas; patients in group B will be given compression decongestive therapy (manual lymphatic drainage, short stretch bandage and exercise therapy). All subjects will be assessed using assessment form, upper limb functional index, dynamometer, pinch meter and tape measure. Assessment will be conducted at base line, after 2 & 4 weeks.

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.
50

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 74200
        • Dr. Ruth K. M. Pfau, Civil Hospital
      • Karachi, Sindh, Pakistan, 74200
        • Sindh Institute Physical Medicine and Redhabilitation

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

35 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 30 to 65
  • Patient undergoing Unilateral Modified Radical Mastectomy
  • Within 1 week post Mastectomy
  • Subjects without swelling or with mild swelling

Exclusion Criteria:

  • active cancer or disease that might lead to swelling
  • subjects taking anticoagulant therapy
  • diagnose skin disease and skin allergies
  • vascular insufficiency
  • sensory impairments
  • open wound and scars which have not healed
  • Functional limitations of upper limb before mastectomy e.g. adhesive capsulitis.

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: K-tapping and exercise (Group A)
Group A will be given kinesiology taping technique and exercise therapy
Other: Kinesiology taping technique with exercise therapy
Kinesiology tape is a latex-free fiber that stretches longitudinally & elastic with an acrylic adhesive. It is used to stimulate dermal mechanoreceptors, encourages sensory and mechanical stimuli resulting in reduction of clogging lymphatic flow which limits the circumference of the affected limb in the region where it is applied due to its flexibility and acts over the lymphatic system. However, exercise therapy is systematic movement program to strengthen muscles.
Active Comparator: Compression decongestive therapy (Group B )
Group B will be given compression decongestive therapy (manual lymphatic drainage, short stretch bandage and exercise therapy)
Other: Compression decongestive therapy

It consists of two phases: First is the intensive phase (volume reduction phase), in this phase short stretch bandage, manual lymphatic drainage, skincare and exercises will be given for a period of 4 weeks.

In the second phase (maintenance phase), compression garments and exercises will be given to the patient for maintaining the limb volume or to reduce the risk of lymphedma.

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
Change form baseline in upper limb function on the upper limb functional index at sixth session
Time Frame: Baseline and 2 weeks
tI is a questionnaire to quantify the disability in people with upper extremity conditions.The patient gives a score to each of 20 listed activities based on the difficulty in completing the activities. It consists of 20 activities items in which a score range from 0 to 80. Where, 80 score shows a high level of function and 0 shows disability, each activity score is 0 to 4.This measurement is used for upper limb function and self-reported by patient.
Baseline and 2 weeks
Change form baseline in upper limb function on the upper limb functional index at twelfth session
Time Frame: Baseline and 4 weeks
It is a questionnaire to quantify the disability in people with upper extremity conditions.The patient gives a score to each of 20 listed activities based on the difficulty in completing the activities. It consists of 20 activities items in which a score range from 0 to 80. Where, 80 score shows a high level of function and 0 shows disability, each activity score is 0 to 4.This measurement is used for upper limb function and self-reported by patient.
Baseline and 4 weeks
Change from baseline in upper limb volume on tape measure at sixth session
Time Frame: Baseline and 2 week
It is a tool used for the arm circumference measurements and to evaluate the degree of lymphedma. The Patient sits on a chair and his arm is flexed to 900. First measure is taken at the wrist and after 10cm proximal to wrist and so on
Baseline and 2 week
Change from baseline in upper limb volume on tape measure at sixth session
Time Frame: Baseline and 4 weeks
It is a tool used for the arm circumference measurements and to evaluate the degree of lymphedma. The Patient sits on a chair and his arm is flexed to 900. First measure is taken at the wrist and after 10cm proximal to wrist and so on
Baseline and 4 weeks
Change from baseline in upper limb strength on dynamometer and pinch meter at sixth session
Time Frame: Baseline and 2 weeks
It is a measurement tool used in physiotherapy to assess the highest isometric strength of hand grasp and fingers. It consists of a hydraulic system with a changeable handle size. It measures the strength in pounds/square inch (psi
Baseline and 2 weeks
Change from baseline in upper limb strength on dynamometer and pinch meter at twelfth session
Time Frame: Baseline and 4 weeks
It is a measurement tool used in physiotherapy to assess the highest isometric strength of hand grasp and fingers. It consists of a hydraulic system with a changeable handle size. It measures the strength in kg.
Baseline and 4 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.
Dow University of Health Sciences

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: Hira Saleem Agwan, MSAPT, Dow University of Health Sciences

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.
April 4, 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.
December 17, 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 17, 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).
December 16, 2021

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.
December 16, 2021

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.
January 5, 2022

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 23, 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.
May 20, 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.
January 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.
  • HSaleem

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

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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