Post Mastectomy LymphedemaNCT05178797
Kinesiology Taping Technique in Post-mastectomy Breast Cancer Related Lymphedema
A study testing Kinesiology taping technique with exercise therapy and Compression decongestive therapy in people with Post Mastectomy Lymphedema, run by Dow University of Health Sciences at 2 sites in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 65 years, women only
- Conditions the study is for
- Post Mastectomy Lymphedema
- What is being tested?
- Kinesiology taping technique with exercise therapy and Compression decongestive therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesPakistan
- Study dates
- 4 Apr 2021to 17 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 30 to 65
- Patient undergoing Unilateral Modified Radical Mastectomy
- Within 1 week post Mastectomy
- Subjects without swelling or with mild swelling
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Dr. Ruth K. M. Pfau, Civil Hospital
Karachi, Sindh, 74200
Sindh Institute Physical Medicine and Redhabilitation
Karachi, Sindh, 74200
About this study
Official title: Effects of Kinesiology Taping Technique in Post-mastectomy Breast Cancer Related Lymphedema on Swelling, Upper Limb Function, and Strength
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.
Read the 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
- Being tested
- Kinesiology taping technique with exercise therapy, Compression decongestive therapy
- Keywords
- physiotherapy, breast cancer, breast carcinoma
- Medical subject headings
- Breast Cancer Lymphedema, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesiology taping technique with exercise therapyOther
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 therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| K-tapping and exercise (Group A) | Experimental | Group A will be given kinesiology taping technique and exercise therapy Receives: 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) Receives: Other: Compression decongestive therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start4 Apr 2021
- Primary completion17 Dec 2022
- Study completion17 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Mastectomy LymphedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to one of groups (A and B) in parallel for the duration of the study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hira Saleem Agwan, MSAPT, Principal investigator, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05178797
- Sponsor's protocol ID
- HSaleem
- Status last verified
- Jan 2023
- First submitted
- 16 Dec 2021
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Kinesiology Taping Technique in Post-mastectomy Breast Cancer Related Lymphedema on Swelling, Upper Limb Function, and Strength
- ClinicalTrials.gov ID
- NCT05178797
- Acronym / sponsor ID
- HSaleem
- Conditions
- Post Mastectomy Lymphedema
- Keywords
- physiotherapy, breast cancer, breast carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 4 Apr 2021 (actual)
- Primary completion
- 17 Dec 2022 (actual)
- Study completion
- 17 Jan 2023 (actual)
- First posted
- 5 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are assigned to one of groups (A and B) in parallel for the duration of the study
| Arm | Type | Receives |
|---|---|---|
| K-tapping and exercise (Group A) | Experimental | Other: Kinesiology taping technique with exercise therapyGroup A will be given kinesiology taping technique and exercise therapy |
| Compression decongestive therapy (Group B ) | Active comparator | Other: Compression decongestive therapyGroup B will be given compression decongestive therapy (manual lymphatic drainage, short stretch bandage and exercise therapy) |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 30 to 65
- Patient undergoing Unilateral Modified Radical Mastectomy
- Within 1 week post Mastectomy
- Subjects without swelling or with mild swelling
Key exclusion criteria (7 listed)
- active cancer or disease that might lead to swelling
- subjects taking anticoagulant therapy
- diagnose skin disease and skin allergies
- vascular insufficiency
- sensory impairments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kinesiology taping technique with exercise therapyKinesiology 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. | Other | K-tapping and exercise (Group A) |
| Compression decongestive therapyIt 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. | Other | Compression decongestive therapy (Group B ) |
Primary outcome
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.
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.
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
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
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
- Individual participant dataSharing planned: No
Related trials for Post Mastectomy Lymphedema
Recruiting
Effect of Resisted Deep Breathing and Myofascial Release in Postmastectomy
Post Mastectomy Lymphedema
Enrolling by invitation
Ultrasound-Guided Percutaneous Cryoneurolysis to Treat Postoperative Pain After Mastectomy
Mastectomy; Lymphedema
Recruiting
Pectoral Nerve Block Versus Paravertebral Block In The Incidence of Chronic Pain After Breast Cancer Surgery
Paravertebral Block, Pectoral Nerve Block
Active, not recruiting
Manual Lymphatic Drainage With Diaphragmatic Breathing Exercises in Post Radical Mastectomy
Breast Cancer Related Lymphedema
Recruiting
Erector Spinae Block Versus Paravertebral Block on Chronic Pain After Mastectomy
Mastectomy; Lymphedema, Chronic Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hira Saleem Agwan, MSAPT principal investigator
Dow University of Health Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesiology taping technique with exercise therapy and Compression decongestive therapy in people with Post Mastectomy Lymphedema, run by Dow University of Health Sciences at 2 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change form baseline in upper limb function on the upper limb functional index at sixth session (time frame: Baseline and 2 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2023.