Clinical trial NCT05178797: 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
Overall status: COMPLETED
Phase: NA
Conditions: Post Mastectomy Lymphedema
Keywords: physiotherapy
breast cancer
breast carcinoma
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
First posted: 2022-01-05
Enrollment: 50
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to one of groups (A and B) in parallel for the duration of the study
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change form baseline in upper limb function on the upper limb functional index at sixth session
timeFrame: Baseline and 2 weeks
measure: Change form baseline in upper limb function on the upper limb functional index at twelfth session
timeFrame: Baseline and 4 weeks
measure: Change from baseline in upper limb volume on tape measure at sixth session
timeFrame: Baseline and 2 week
measure: Change from baseline in upper limb volume on tape measure at sixth session
timeFrame: Baseline and 4 weeks
measure: Change from baseline in upper limb strength on dynamometer and pinch meter at sixth session
timeFrame: Baseline and 2 weeks
measure: Change from baseline in upper limb strength on dynamometer and pinch meter at twelfth session
timeFrame: Baseline and 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Dr. Ruth K. M. Pfau, Civil Hospital
state: Sindh
city: Karachi
country: Pakistan
facility: Sindh Institute Physical Medicine and Redhabilitation
state: Sindh
Study officials:
affiliation: Dow University of Health Sciences
name: Hira Saleem Agwan, MSAPT
role: PRINCIPAL_INVESTIGATOR
References: