Comparative Effects of KT and PG on UE Lymphedema and Functional Disability After Mastectomy

March 7, 2023 updated by: Riphah International University

Comparative Effects of Kinesio Tapping and Pressure Garments on Upper Extremity Lymphedema, Functional Disability and Quality of Life After Mastectomy

To compare the effects of Kinesio taping and compression garmets on the upper extremity lymphedema,functional disability and quality of life after mastectomy.

Study Overview

Status

Status

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

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

The study's primary goal was to find the effects of Kinesio taping and compression garments on the upper extremity lymphedema following mastectomy. This aim was realized through the current study results, the findings of the current study showed that Kinesio taping and compression garments were equally effective on the upper extremity lymphedema following mastectomy.

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 (Anticipated)

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 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
    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • Recruiting
        • Lahore General Hospital
        • Principal Investigator:
          • Dania Sardar, m phil
        • Sub-Investigator:
          • Sobia Kanwal

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

45 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • • Age (45 years-75 years)

    • Patients with edema after 1-year mastectomy
    • Unilateral lymphedema
    • Arm circumference change (Arm circumference unilateral than 2 cm or less than 8 cm in comparison with the other side was included)
    • Functional disability or limited movements (shoulder, arm, and hand)

Exclusion Criteria:

  • • Active disease leading to swelling

    • Patients on medications, especially diuretics
    • Allergy
    • Infection
    • Pregnancy
    • Heart and kidney diseases
    • Bilateral lymphedema
    • Skin diseases
    • Cellulitis.

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

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: Effect of kinesio taping on upper limb lymphedema
Kinesio taping was applied 2 times a week for 3 weeks to the KT group. KT improves fluid movement by widening the distance between connective tissues like skin and fascia,fascia and muscles and skin and muscles.
Other: Effect of kinesio taping on upper limb lymphedema
Group A received Kinesio taping 2 times a week for 3 weeks to reduce lymphedema and Group B received pressure garments(20-60 mm Hg) for at least 15 to 18 hours per day for 3 weeks
Other Names:
  • USE of Pressure Garments with coventional PT
Active Comparator: Effect of pressure garments on upper limb lymphedema
PG group received pressure garments ( 20-60 mmHg)for at least 15 to 18 hours per day for 3 weeks.
Other: Effect of kinesio taping on upper limb lymphedema
Group A received Kinesio taping 2 times a week for 3 weeks to reduce lymphedema and Group B received pressure garments(20-60 mm Hg) for at least 15 to 18 hours per day for 3 weeks
Other Names:
  • USE of Pressure Garments with coventional PT

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
Girth Measurement (with Tape)
Time Frame: 3 weeks
The tape was used to assess the limb diameter.
3 weeks
Handgrip strength was evaluated using a dynamometer
Time Frame: 3 weeks
A dynamometer was used to assess muscle strengthening and hand grip strengthening
3 weeks
The quality of life was assessed by a cancer-specific questionnaire (EORTC QLQ-C30)
Time Frame: 3 weeks
The EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30) was used to assess the physical, psychological, and social well-being of cancer patients. The EORTC QLQ-C30 was proven to be useful and valid in measuring the quality of life in patients with advanced illness in this investigation
3 weeks
Disabilities of arm, Shoulder and Hand Questionnaire (DASH)
Time Frame: 3 weeks
The function was assessed using the validated 30-item Quick-Disabilities of Arm, Shoulder, and Hand (Quick DASH) assessment. Respondents are asked to score their capacity to undertake specific activities (such as heavy housework or carrying a shopping bag); the degree of interference with regular social activities, work activities, sleep impairment, pain ratings, and altered sensations
3 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.
Riphah International 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: dania sardar, Riphah IU
  • Study Director: Sobia Kanwal, Riphah IU

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.
December 25, 2021

Primary Completion (Anticipated)

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.
March 1, 2023

Study Completion (Anticipated)

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.
March 30, 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).
February 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.
March 7, 2023

First Posted (Estimate)

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.
March 9, 2023

Study Record Updates

Last Update Posted (Estimate)

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.
March 9, 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.
March 7, 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.
March 1, 2023

More Information

Terms related to this study

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.
  • REC/RCR & AHS/22/0547

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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