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LymphedemaLYMPHEDEMANCT06808178

EFFECT OF KINESIO TAPING AND LASER THERAPY IN PATIENT WITH LYMPHEDEMA ON GIRTH MEASUREMENT

A study testing Low Level Laser Therapy and kinesio taping in people with Lymphedema and Breast Cancer Stage II, run by Beni-Suef University at 2 sites in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

find out the difference in the effect of kinesio taping and low level laser therapy on 90 patients with post mastectomy lymphedema as regards the following outcomes: 1.girth measurement between the upper limbs 2.) SPADI 3) hand grip strength 4)the quality of life by cancer specific questionnaire. Read more about this study

Who is it for?
Ages 40 to 55 years, women only
Conditions the study is for
Lymphedema, Breast Cancer Stage II
What is being tested?
Low Level Laser Therapy and kinesio taping
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
2 sitesEgypt
Study dates
1 Feb 2025to 1 Sep 2025
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 40 to 55 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • persistence of lymphedema following mastectomy or breast conservative surgery for at least 3 months
  • minimum volume difference of 200 mL or an average difference in arm circumference of 2 cm or 10% between healthy and affected limbs.
  • Femal with unilateral lymphedema from 40 to 55 years old

Who cannot join

  • • Any disease lead to swelling
  • Medication especially diuretics
  • allergy
  • infection
  • pregnancy
  • heart band kidney disease
Show all 9Show fewer
  • bilateral lymphedema
  • skin disease
  • chronic inflammatory disease

Trial locations and contacts

2 sites in 1 country.

Egypt2 sites

  • Cairo University Hospital

    Cairo, Cairo Governorate, 11865

  • Cairo -Beni-Suif University Hospital

    GIZA, Cairo Governorate, 11865

Other trials in Egypt

About this study

Official title: THE EFFECT OF KINESIO TAPING AND LOW LEVEL LASER THERAPY IN PATIENT WITH POST MASTECTOMY RELATED LYMPHEDEMA ON GIRTH MEASUREMENT

find out the difference in the effect of kinesio taping and low level laser therapy on 90 patients with post mastectomy lymphedema as regards the following outcomes:

1.girth measurement between the upper limbs 2.) SPADI 3) hand grip strength 4)the quality of life by cancer specific questionnaire.

Read the detailed description

90 females with BCRL will be recruited in this study for 4 weeks , their age ranged from 40 to 55 years old with stege 1,2 lymphedema and randomly divided into 3 equal groups: 2) study group (A) include 30 females with unilateral BCRL will receive kinesio taping plus manual lymphatic drainage , exercise and advices 3) study group (B) include 30 females with unilateral BCRL will receive low level laser therapy plus manual lymphatic drainage , exercise and advices 4) study group (C) include 30 females with unilateral BCRL will receive kinesio taping plus low level laser therapy and manual lymphatic drainage , exercise and advices regards the following outcomes:

1.girth measurement between the upper limbs 2.) SPADI 3) hand grip strength 4)the quality of life by cancer specific questionnaire.

Being tested
Low Level Laser Therapy, kinesio taping
Keywords
laser taping
Medical subject headings
Lymphedema, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low Level Laser TherapyDevice

    The device has the following treatment parametes :

    • Maximum average power > 500 milli watts
    • Wave length combined (904-808) nm
    • Maximum repition rate (1-2000) Hz
    • Energy density : 4:6 J per cm per session

  • kinesio tapingOther

    • the material used is 100%acrylic,latex free and heat activated with 10-15% stretch.
    • It is made of 100% cotton to allow quickening of the drying process.
    • Ability to stretch to 120-140% of its original length
    • Recoil back to the anchor that is applied without stretch
    • Heat-activated adhesive
    • Hypoallergenic dyes that make the tape safe for most users
    • Latex-free
    • Drying time after being wet is about 5-10 minutes
    • Can be worn for several days
Study groups in NCT06808178
Study groupRoleWhat they receive
group AExperimentalstudy group (A) include 30 females with unilateral BCRL will receive kinesio taping plus manual lymphatic drainage , exercise and advices
Receives: Other: kinesio taping
Group BExperimentalstudy group (B) include 30 females with unilateral BCRL will receive low level laser therapy plus manual lymphatic drainage , exercise and advices
Receives: Device: Low Level Laser Therapy
Group CExperimentalstudy group (C) include 30 females with unilateral BCRL will receive kinesio taping plus low level laser therapy and manual lymphatic drainage , exercise and advices
Receives: Device: Low Level Laser Therapy; Other: kinesio taping

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. girth measurment

    Measurement of arm circumference is the most commonly used technique for identifying lymphedema and is reliable for both surgical and nonsurgical upper limbs It is measured using a tape with the patient in prone lying position, with elbows straight and arms relaxed at the sides. It was measured starting with 3 cm on the ulnar styloid process and proceeding with 45 cm proximal, and additionally at the metacarpal bones and mid-hand. The tape measure was put around the limb to prevent it from slacking and to ensure that there was no space in the tissue. The total circumference of the sound limb was ascertained similarly. The difference between the 2 measurements was identified using "circumference difference."

    Measured: 4 weeks

Secondary outcomes (3)

  1. shoulder pain and disability index

    was used to assess shoulder pain and disability. It incorporates 13 items assessing 2 domains: 5 items assess pain and 8 items evaluate disability.

    Measured: 4 weeks

  2. quality of life questionnaire

    was assessed by cancer-specific questionnaire (EORTC QLQ-C30). It is composed of 30 questions, including functional scores (physical, social, emotional, and cognitive aspects). The functional scores ranged between 0 and 100, and higher scores indicated better condition. This questionnaire also included symptoms score (pain, dyspnea, fatigue, insomnia, nausea, loss of appetite, and financial problems). The symptom scores ranged from 100 to 0, and lower scores indicated better condition

    Measured: 4 weeks

  3. handgrip strength

    evaluated using a dynamometer ,The grip strength was measured with the patient in a standing position with adducted shoulder, elbow flexed at 90°, and forearm in mid position. The patient was instructed to do 3 trials with 15 seconds rest in between each, and the highest reading was reported

    Measured: 4 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2025
  2. Study start1 Feb 2025
  3. Primary completion1 Sep 2025
  4. Study completion1 Sep 2025

Resources

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
90 females with BCRL will be recruited in this study for 4 weeks , their age ranged from 40 to 55 years old with stege 1,2 lymphedema and randomly divided into 3 equal groups: 2) study group (A) include 30 females with unilateral BCRL will receive kinesio taping plus manual lymphatic drainage , exercise and advices 3) study group (B) include 30 females with unilateral BCRL will receive low level laser therapy plus manual lymphatic drainage , exercise and advices 4) study group (C) include 30 females with unilateral BCRL will receive kinesio taping plus low level laser therapy and manual lymphatic drainage , exercise and advices
Masking
None (open label)
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06808178
Sponsor's protocol ID
FMBSUREC/02012024/Zaki
Acronym
LYMPHEDEMA
Status last verified
Nov 2026
First submitted
29 Jan 2025
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Low Level Laser Therapy and kinesio taping in people with Lymphedema and Breast Cancer Stage II, run by Beni-Suef University at 2 sites in Egypt.

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 3 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: finished, as of the sponsor's last update on 6 Nov 2026. 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 Egypt. 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?

girth measurment (time frame: 4 weeks). 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 NCT06808178.

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 6 Nov 2026.

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