Lymphedema of Upper LimbNCT05762224
Comparative Effects of KT and PG on UE Lymphedema and Functional Disability After Mastectomy
A study testing Effect of kinesio taping on upper limb lymphedema in people with Lymphedema of Upper Limb, run by Riphah International University at 1 site in Pakistan.
Trial summary
To compare the effects of Kinesio taping and compression garmets on the upper extremity lymphedema,functional disability and quality of life after mastectomy. Read more about this study
- Who is it for?
- Ages 45 to 75 years, women only
- Conditions the study is for
- Lymphedema of Upper Limb
- What is being tested?
- Effect of kinesio taping on upper limb lymphedema
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 25 Dec 2021to 30 Mar 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 45 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Age (45 years-75 years)
- Patients with edema after 1-year mastectomy
- Unilateral lymphedema
- Arm circumference change (Arm circumference unilateral than 2 cm or less than 8 cm in comparison with the other side was included)
- Functional disability or limited movements (shoulder, arm, and hand)
Who cannot join
- • Active disease leading to swelling
- Patients on medications, especially diuretics
- Allergy
- Infection
- Pregnancy
- Heart and kidney diseases
Show all 9Show fewer
- Bilateral lymphedema
- Skin diseases
- Cellulitis.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Lahore General Hospital
Lahore, Punjab Province, 54000
Dania Sardar, m phil
Sobia Kanwal
About this study
Official title: Comparative Effects of Kinesio Tapping and Pressure Garments on Upper Extremity Lymphedema, Functional Disability and Quality of Life After Mastectomy
To compare the effects of Kinesio taping and compression garmets on the upper extremity lymphedema,functional disability and quality of life after mastectomy.
Read the detailed description
The study's primary goal was to find the effects of Kinesio taping and compression garments on the upper extremity lymphedema following mastectomy. This aim was realized through the current study results, the findings of the current study showed that Kinesio taping and compression garments were equally effective on the upper extremity lymphedema following mastectomy.
- Conditions
- Lymphedema of Upper Limb
- Being tested
- Effect of kinesio taping on upper limb lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effect of kinesio taping on upper limb lymphedemaOther
Also called USE of Pressure Garments with coventional PT
Group A received Kinesio taping 2 times a week for 3 weeks to reduce lymphedema and Group B received pressure garments(20-60 mm Hg) for at least 15 to 18 hours per day for 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Effect of kinesio taping on upper limb lymphedema | Experimental | Kinesio taping was applied 2 times a week for 3 weeks to the KT group. KT improves fluid movement by widening the distance between connective tissues like skin and fascia,fascia and muscles and skin and muscles. Receives: Other: Effect of kinesio taping on upper limb lymphedema |
| Effect of pressure garments on upper limb lymphedema | Active comparator | PG group received pressure garments ( 20-60 mmHg)for at least 15 to 18 hours per day for 3 weeks. Receives: Other: Effect of kinesio taping on upper limb lymphedema |
What is being measured
The primary outcome is the main question the study is designed to answer.
Girth Measurement (with Tape)
The tape was used to assess the limb diameter.
Measured: 3 weeks
Handgrip strength was evaluated using a dynamometer
A dynamometer was used to assess muscle strengthening and hand grip strengthening
Measured: 3 weeks
The quality of life was assessed by a cancer-specific questionnaire (EORTC QLQ-C30)
The EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30) was used to assess the physical, psychological, and social well-being of cancer patients. The EORTC QLQ-C30 was proven to be useful and valid in measuring the quality of life in patients with advanced illness in this investigation
Measured: 3 weeks
Disabilities of arm, Shoulder and Hand Questionnaire (DASH)
The function was assessed using the validated 30-item Quick-Disabilities of Arm, Shoulder, and Hand (Quick DASH) assessment. Respondents are asked to score their capacity to undertake specific activities (such as heavy housework or carrying a shopping bag); the degree of interference with regular social activities, work activities, sleep impairment, pain ratings, and altered sensations
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study start25 Dec 2021
- Primary completionMar 2023 (estimated)
- Study completion30 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lymphedema of Upper LimbStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- dania sardar, Principal investigator, Riphah IUSobia Kanwal, Study director, Riphah IU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05762224
- Sponsor's protocol ID
- REC/RCR & AHS/22/0547
- Status last verified
- Mar 2023
- First submitted
- 20 Feb 2023
- Last updated
- 9 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bao T, Iris Zhi W, Vertosick EA, Li QS, DeRito J, Vickers A, Cassileth BR, Mao JJ, Van Zee KJ. Acupuncture for breast cancer-related lymphedema: a randomized controlled trial. Breast Cancer Res Treat. 2018 Jul;170(1):77-87. doi: 10.1007/s10549-018-4743-9. Epub 2018 Mar 8.
PubMed 29520533Oliveira MMF, Gurgel MSC, Amorim BJ, Ramos CD, Derchain S, Furlan-Santos N, Dos Santos CC, Sarian LO. Long term effects of manual lymphatic drainage and active exercises on physical morbidities, lymphoscintigraphy parameters and lymphedema formation in patients operated due to breast cancer: A clinical trial. PLoS One. 2018 Jan 5;13(1):e0189176. doi: 10.1371/journal.pone.0189176. eCollection 2018.
PubMed 29304140Munoz-Alcaraz MN, Perula-de-Torres LA, Serrano-Merino J, Jimenez-Vilchez AJ, Olmo-Carmona MV, Munoz-Garcia MT, Bartolome-Moreno C, Olivan-Blazquez B, Magallon-Botaya R. Efficacy and efficiency of a new therapeutic approach based on activity-oriented proprioceptive antiedema therapy (TAPA) for edema reduction and improved occupational performance in the rehabilitation of breast cancer-related arm lymphedema in women: a controlled, randomized clinical trial. BMC Cancer. 2020 Nov 9;20(1):1074. doi: 10.1186/s12885-020-07558-x.
PubMed 33167921
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Kinesio Tapping and Pressure Garments on Upper Extremity Lymphedema, Functional Disability and Quality of Life After Mastectomy
- ClinicalTrials.gov ID
- NCT05762224
- Acronym / sponsor ID
- REC/RCR & AHS/22/0547
- Conditions
- Lymphedema of Upper Limb
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 25 Dec 2021 (actual)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- 30 Mar 2023 (estimated)
- First posted
- 9 Mar 2023 (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.
To compare the effects of Kinesio taping and compression garmets on the upper extremity lymphedema,functional disability and quality of life after mastectomy.
Detailed description
The study's primary goal was to find the effects of Kinesio taping and compression garments on the upper extremity lymphedema following mastectomy. This aim was realized through the current study results, the findings of the current study showed that Kinesio taping and compression garments were equally effective on the upper extremity lymphedema following mastectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Effect of kinesio taping on upper limb lymphedema | Experimental | Other: Effect of kinesio taping on upper limb lymphedemaKinesio taping was applied 2 times a week for 3 weeks to the KT group. KT improves fluid movement by widening the distance between connective tissues like skin and fascia,fascia and muscles and skin and muscles. |
| Effect of pressure garments on upper limb lymphedema | Active comparator | Other: Effect of kinesio taping on upper limb lymphedemaPG group received pressure garments ( 20-60 mmHg)for at least 15 to 18 hours per day for 3 weeks. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- • Age (45 years-75 years)
Key exclusion criteria (9 listed)
- • Active disease leading to swelling
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 |
|---|---|---|
| Effect of kinesio taping on upper limb lymphedemaAlso: USE of Pressure Garments with coventional PTGroup A received Kinesio taping 2 times a week for 3 weeks to reduce lymphedema and Group B received pressure garments(20-60 mm Hg) for at least 15 to 18 hours per day for 3 weeks | Other | Effect of kinesio taping on upper limb lymphedema, Effect of pressure garments on upper limb lymphedema |
Primary outcome
Girth Measurement (with Tape)
Time frame: 3 weeks
The tape was used to assess the limb diameter.
Handgrip strength was evaluated using a dynamometer
Time frame: 3 weeks
A dynamometer was used to assess muscle strengthening and hand grip strengthening
The quality of life was assessed by a cancer-specific questionnaire (EORTC QLQ-C30)
Time frame: 3 weeks
The EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30) was used to assess the physical, psychological, and social well-being of cancer patients. The EORTC QLQ-C30 was proven to be useful and valid in measuring the quality of life in patients with advanced illness in this investigation
Disabilities of arm, Shoulder and Hand Questionnaire (DASH)
Time frame: 3 weeks
The function was assessed using the validated 30-item Quick-Disabilities of Arm, Shoulder, and Hand (Quick DASH) assessment. Respondents are asked to score their capacity to undertake specific activities (such as heavy housework or carrying a shopping bag); the degree of interference with regular social activities, work activities, sleep impairment, pain ratings, and altered sensations
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2023.
- Background: PubMed 29520533Bao T, Iris Zhi W, Vertosick EA, Li QS, DeRito J, Vickers A, Cassileth BR, Mao JJ, Van Zee KJ. Acupuncture for breast cancer-related lymphedema: a randomized controlled trial. Breast Cancer Res Treat. 2018 Jul;170(1):77-87. doi: 10.1007/s10549-018-4743-9. Epub 2018 Mar 8.
- Background: PubMed 29304140Oliveira MMF, Gurgel MSC, Amorim BJ, Ramos CD, Derchain S, Furlan-Santos N, Dos Santos CC, Sarian LO. Long term effects of manual lymphatic drainage and active exercises on physical morbidities, lymphoscintigraphy parameters and lymphedema formation in patients operated due to breast cancer: A clinical trial. PLoS One. 2018 Jan 5;13(1):e0189176. doi: 10.1371/journal.pone.0189176. eCollection 2018.
- Results publication: PubMed 33167921Munoz-Alcaraz MN, Perula-de-Torres LA, Serrano-Merino J, Jimenez-Vilchez AJ, Olmo-Carmona MV, Munoz-Garcia MT, Bartolome-Moreno C, Olivan-Blazquez B, Magallon-Botaya R. Efficacy and efficiency of a new therapeutic approach based on activity-oriented proprioceptive antiedema therapy (TAPA) for edema reduction and improved occupational performance in the rehabilitation of breast cancer-related arm lymphedema in women: a controlled, randomized clinical trial. BMC Cancer. 2020 Nov 9;20(1):1074. doi: 10.1186/s12885-020-07558-x.
- Individual participant dataSharing planned: No
Related trials for Lymphedema of Upper Limb
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
Enrolling by invitation
Comparison of the Effects of Kinesio Taping and Compression Bandaging on Edema, Range of Motion, Upper Extremity Function, and Grip Strength in Patients With Breast Cancer-Related Lymphedema
Lymphedema, Lymphedema Arm
Not yet recruiting
Agentic AI App and Home Bioimpedance Monitoring for Endocrine Therapy Adherence and Lymphedema in Breast Cancer Survivors
Breast Neoplasm Malignant Primary, Lymphedema Arm
Active, not recruiting
The Effectiveness of Lymphatic Bypass Supermicrosurgery
Breast Cancer Related Lymphedema, Lymphedema Arm
Recruiting
Lymphovenous Bypass Procedure for Secondary Prevention of Lymphedema in Breast Cancer
Lymphedema Arm
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.
dania sardar principal investigator
Riphah IU
Sobia Kanwal study director
Riphah IU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Effect of kinesio taping on upper limb lymphedema in people with Lymphedema of Upper Limb, run by Riphah International University at 1 site 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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 9 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fatima Tariq, m-phil (03338789778, fatima.tariq@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Girth Measurement (with Tape) (time frame: 3 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05762224, which also lists 3 linked publications.
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 9 Mar 2023.