Kinesiology Taping Technique in Post-mastectomy Breast Cancer Related Lymphedema

NCT05178797 | Completed DMC

• 1 other identifier: HSaleem
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Post Mastectomy Lymphedema

Keywords

physiotherapy; breast cancer; breast carcinoma

Outcome Measures

Primary Outcomes (6)

• 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.

  Baseline and 2 weeks

• 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.

  Baseline and 4 weeks

• 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

  Baseline and 2 week

• 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

  Baseline and 4 weeks

• 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

  Baseline and 2 weeks

• 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.

  Baseline and 4 weeks

Study Arms (2)

K-tapping and exercise (Group A)

EXPERIMENTAL

Group A will be given kinesiology taping technique and exercise therapy

Other: Kinesiology taping technique with exercise therapy

Compression decongestive therapy (Group B )

ACTIVE COMPARATOR

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

Other: Compression decongestive therapy

Interventions

Kinesiology taping technique with exercise therapy 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.

K-tapping and exercise (Group A)

Compression decongestive therapy 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.

Compression decongestive therapy (Group B )

Eligibility Criteria

• Age: 35 Years - 65 Years
• Gender Eligibility Details: The study condition can be present in female gender only.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (2)

Dr. Ruth K. M. Pfau, Civil Hospital

Karachi, Sindh, 74200, Pakistan

Location

Sindh Institute Physical Medicine and Redhabilitation

Karachi, Sindh, 74200, Pakistan

Location

MeSH Terms

Conditions

Breast Cancer Lymphedema; Breast Neoplasms

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Lymphedema; Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Hira Saleem Agwan, MSAPT

  Dow University of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Statistician will also be masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are assigned to one of groups (A and B) in parallel for the duration of the study

Study Record Dates

• First Submitted: December 16, 2021
• First Posted: January 5, 2022
• Study Start: April 4, 2021
• Primary Completion: December 17, 2022
• Study Completion: January 17, 2023
• Last Updated: May 23, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (2)