Kinesiology Taping Technique in Post-mastectomy Breast Cancer Related Lymphedema

NCT ID: NCT05178797

Last Updated: 2023-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-04
• Study Completion Date: 2023-01-17

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.

Conditions

Post Mastectomy Lymphedema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

K-tapping and exercise (Group A)

Group A will be given kinesiology taping technique and exercise therapy

Group Type: EXPERIMENTAL

Kinesiology taping technique with exercise therapy

Intervention Type: OTHER

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.

Compression decongestive therapy (Group B )

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

Group Type: ACTIVE_COMPARATOR

Compression decongestive therapy

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Dow University of Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hira Saleem Agwan, MSAPT

Role: PRINCIPAL_INVESTIGATOR

Dow University of Health Sciences

Locations

Dr. Ruth K. M. Pfau, Civil Hospital

Karachi, Sindh, Pakistan

Sindh Institute Physical Medicine and Redhabilitation

Karachi, Sindh, Pakistan

Countries

Pakistan

Other Identifiers

HSaleem

Identifier Type: -

Identifier Source: org_study_id