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CompletedNCT03401086Updated Jan 17, 2018

Comparison of Kinesiotaping and Pressure Garment on Women With Upper Extremity Lymphedema Following Mastectomy

An interventional study of Kinesio Taping in Breast Cancer Lymphedema, sponsored by Ahlia University. Completed at 2 sites in Egypt. Open to female participants aged 45 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-01-17.

Sponsored by Ahlia University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Feb 2017, registered Dec 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
45 Years to 60 Years
Sex
Female
01

Study summary

Breast cancer is a standout amongst the most widely recognized cancer among women. It is observed that upper extremity lymphedema is one of the most dangerous and prevalent complication following breast cancer surgery which prompts functional impairment, psychological disaster and social problems

This study aimed to compare the effects of Kinesio taping and the pressure garment application on secondary lymphedema of the upper extremity and quality of life following mastectomy after breast cancer.

Material and Methods: In this experimental study with pre and post-tests, 66 women with lymphedema following mastectomy were randomly allocated to Kinesio taping (KT) group (n=33) and pressure garment (PG) group (n=33). The KT group received Kinesio taping application, while the PG group received pressure garment (40-60 mmHg) for at least 15-18 hours per day through the study. All patients were evaluated to record the changes of the limb circumference, Shoulder Pain and Disability Index (SPADI), hand grip strength and quality of life at baseline and end of intervention.

Read the detailed description

66 women with unilateral breast cancer related to lymphedema (stage II and III) for at least for 6 months were invited to participate in the study. Lymphoma was more than 2 cm in arm circumference or less than 8 cm in comparison with the other side. The participants were randomly assigned to 2 groups. Kinesio taping group included 33 patients receiving Kinesio taping (KT) and pressure garment (PG) included 33 patients.

The exclusion criteria were any active disease which leads to swelling, medications, especially diuretics, allergy, infection, pregnancy, heart and kidney diseases, bilateral lymphedema and cellulitis.

All patients were evaluated to record the changes of the limb circumference, Shoulder Pain and Disability Index (SPADI), hand grip strength and quality of life

02

Conditions studied

  • Breast Cancer Lymphedema
03

In context

Breast Cancer Lymphedema

124 studies on the registry are indexed under Breast Cancer Lymphedema; 40 are open to participants now.

This study's enrollment of 66 is above the median of 48 across 97 interventional studies indexed under Breast Cancer Lymphedema.

Browse Breast Cancer Lymphedema studies →

Lead sponsor

Ahlia University is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • unilateral breast cancer related to lymphedema (stage II and III) for at least for 6 months were invited to participate in the study. Lymphoma was more than 2 cm in arm circumference or less than 8 cm in comparison with the other side.

Exclusion criteria

Exclusion Criteria:

  • The exclusion criteria were any active disease which leads to swelling, medications, especially diuretics, allergy, infection, pregnancy, heart and kidney diseases, bilateral lymphedema and cellulitis.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
66 participants (actual)

Study arms

  • Active comparator
    Study group

    Kinesio Taping

    Other: Kinesio Taping

  • No intervention
    Control group

    No intervention

Interventions

  • OtherKinesio Taping

    Kinesio Taping

06

What researchers measure

Primary outcomes

  1. Limb circumference

    The upper Limbs circumferences were measured by using a tape measure with the patient in prone lying position.

    Time frame: 1 month

Secondary outcomes

  1. Shoulder Pain and Disability Index

    Shoulder Pain and Disability Index (SPADI) survey was created to assess the shoulder pain and disability. It incorporates of 13 items that assess two domains: a 5 items that assess pain and an 8 items that evaluate disability.

    Time frame: 1 month

  2. Hand grip strength

    Hand grip strength was evaluated by Dynamometer (78010, Lafayette Instrument Company, Loughboroug, Leics, United Kingdom). The grip strength was measured while the patient was in a standing position with adducted shoulder, flexed elbow 90 degrees and forearm in mid position.

    Time frame: 1 month

  3. Quality of life

    The quality of life was assessed by utilizing cancer-specific questionnaire (EORTC) QLQ-C30 before and after intervention. QLQ-C30 comprised of 30 questions, including functional scores (physical, social, emotional, and cognitive aspects).

    Time frame: 1 month

07

Study locations

2 sites
  • Dr Dalia Kamel
    Giza, Egypt
  • Dr Sayed Tanatwy
    Giza, Egypt
08

References and documents

Publications

  • Tantawy SA, Abdelbasset WK, Nambi G, Kamel DM. Comparative Study Between the Effects of Kinesio Taping and Pressure Garment on Secondary Upper Extremity Lymphedema and Quality of Life Following Mastectomy: A Randomized Controlled Trial. Integr Cancer Ther. 2019 Jan-Dec;18:1534735419847276. doi: 10.1177/1534735419847276. PubMed 31068019 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2017 to primary completion in Jun 2017, 4 months.

Of 66 non-industry interventional studies with no phase under Breast Cancer Lymphedema, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 34. This study's 4 months is below that.

Counting every sponsor, half of 69 studies reached it within 18 months; a quarter within 10 and three quarters within 34.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 25, 2017
First posted
Jan 17, 2018
StartActual
Feb 4, 2017
Primary completionActual
Jun 7, 2017
CompletionActual
Nov 1, 2017
Last update
Jan 17, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 17, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03401086
Lead sponsor
Ahlia University
Collaborators
Cairo University
Responsible party
Dr Sayed Tantawy (Associate Professor, Ahlia University) — Principal investigator
First posted
Jan 17, 2018
Start date
Feb 4, 2017
Primary completion
Jun 7, 2017
Completion
Nov 1, 2017
Last update
Jan 17, 2018

Study contacts

Sayed A Tantawy
study director · Cairo University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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