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Kinesiology Taping Technique in Post-mastectomy Breast Cancer Related Lymphedema

Primary Purpose

Post Mastectomy Lymphedema

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Kinesiology taping technique with exercise therapy
Compression decongestive therapy
Sponsored by
Dow University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Mastectomy Lymphedema focused on measuring physiotherapy, breast cancer, breast carcinoma

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

K-tapping and exercise (Group A)

Compression decongestive therapy (Group B )

Arm Description

Group A will be given kinesiology taping technique and exercise therapy

Group B will be given compression decongestive therapy (manual lymphatic drainage, short stretch bandage and exercise therapy)

Outcomes

Primary Outcome Measures

Change form baseline in upper limb function on the upper limb functional index at sixth session
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.
Change form baseline in upper limb function on the upper limb functional index at twelfth session
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.
Change from baseline in upper limb volume on tape measure at sixth session
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
Change from baseline in upper limb volume on tape measure at sixth session
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
Change from baseline in upper limb strength on dynamometer and pinch meter at sixth session
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
Change from baseline in upper limb strength on dynamometer and pinch meter at twelfth session
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.

Secondary Outcome Measures

Full Information

First Posted
December 16, 2021
Last Updated
May 20, 2023
Sponsor
Dow University of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05178797
Brief Title
Kinesiology Taping Technique in Post-mastectomy Breast Cancer Related Lymphedema
Official Title
Effects of Kinesiology Taping Technique in Post-mastectomy Breast Cancer Related Lymphedema on Swelling, Upper Limb Function, and Strength
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
April 4, 2021 (Actual)
Primary Completion Date
December 17, 2022 (Actual)
Study Completion Date
January 17, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dow University of Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Mastectomy Lymphedema
Keywords
physiotherapy, breast cancer, breast carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are assigned to one of groups (A and B) in parallel for the duration of the study
Masking
Outcomes Assessor
Masking Description
Statistician will also be masked.
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
K-tapping and exercise (Group A)
Arm Type
Experimental
Arm Description
Group A will be given kinesiology taping technique and exercise therapy
Arm Title
Compression decongestive therapy (Group B )
Arm Type
Active Comparator
Arm Description
Group B will be given compression decongestive therapy (manual lymphatic drainage, short stretch bandage and exercise therapy)
Intervention Type
Other
Intervention Name(s)
Kinesiology taping technique with exercise therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Compression decongestive therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change form baseline in upper limb function on the upper limb functional index at sixth session
Description
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.
Time Frame
Baseline and 2 weeks
Title
Change form baseline in upper limb function on the upper limb functional index at twelfth session
Description
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.
Time Frame
Baseline and 4 weeks
Title
Change from baseline in upper limb volume on tape measure at sixth session
Description
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
Time Frame
Baseline and 2 week
Title
Change from baseline in upper limb volume on tape measure at sixth session
Description
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
Time Frame
Baseline and 4 weeks
Title
Change from baseline in upper limb strength on dynamometer and pinch meter at sixth session
Description
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
Time Frame
Baseline and 2 weeks
Title
Change from baseline in upper limb strength on dynamometer and pinch meter at twelfth session
Description
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.
Time Frame
Baseline and 4 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
The study condition can be present in female gender only.
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hira Saleem Agwan, MSAPT
Organizational Affiliation
Dow University of Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Ruth K. M. Pfau, Civil Hospital
City
Karachi
State/Province
Sindh
ZIP/Postal Code
74200
Country
Pakistan
Facility Name
Sindh Institute Physical Medicine and Redhabilitation
City
Karachi
State/Province
Sindh
ZIP/Postal Code
74200
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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Kinesiology Taping Technique in Post-mastectomy Breast Cancer Related Lymphedema

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