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NCT Number: NCT05178797

Kinesiology Taping Technique in Post-mastectomy Breast Cancer Related Lymphedema

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.

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Key information

Conditions

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

Age range

35 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Ruth K. M. Pfau, Civil Hospital, Karachi, Sindh, Pakistan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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

  5. 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

  6. 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.

Sponsors and collaborators

Lead sponsor

Dow University of Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jan 5, 2022
Registry last updated
May 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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