MastectomyNCT06701591
Kinesio-Taping and Chest Physiotherapy Program After Mastectomy
A study testing Kinesiotaping and chest physical therapy in people with Mastectomy, run by Cairo University at 1 site in Egypt.
Trial summary
The modified radical mastectomy (MRM) is a major surgical approach that necessitates the dissection of axillary lymph nodes. As a result, there is more bleeding and the treatment takes longer time. This treatment is used to treat locally advanced breast cancer. Read more about this study
- Who is it for?
- Ages 30 to 50 years, women only
- Conditions the study is for
- Mastectomy
- What is being tested?
- Kinesiotaping and chest physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Dec 2024to 30 Jul 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 30 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Females aged between 30 and 50 years
- Participants after modified radical mastectomy
- Participants able to comprehend instructions.
- Cooperative participants, and willing to participate in the study.
Who cannot join
- Participants having sensitive skin, scars, or lesions.
- Participants with unhealed incisions at the site of application.
- Participants with uncontrolled diabetes.
- Participants with deep vein thrombosis.
- Participants with previous chest diseases.
- Pregnancy.
Show all 9Show fewer
- Participants with altered sensations.
- Participants with allodynia.
- Participants with active infection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Combined Kinesio-Taping With Chest Physiotherapy Program on Pain, Pulmonary Function, Respiratory Muscle Strength and Quality of Life After Mastectomy: A Randomized Controlled Trial
The modified radical mastectomy (MRM) is a major surgical approach that necessitates the dissection of axillary lymph nodes. As a result, there is more bleeding and the treatment takes longer time. This treatment is used to treat locally advanced breast cancer. Numerous factors, including pain and respiratory depression from general anaesthesia, can impair respiratory function during the post-operative period. Pain causes the thoracic cage's post-operative movement to be restricted and the breathing muscles to become inhibited.
Read the detailed description
KT is a new technology that is being used in the treatment of post-surgical and respiratory problems, among other innovative evidence-based therapeutic options in patient care. Recently, this method is useful for treating a variety of sports-related and musculoskeletal disorders, as well as pain management. According to a small body of research on the usefulness and efficacy of KT in treating respiratory conditions in patients with chronic obstructive pulmonary disease (COPD), it can lead to improvements in respiratory muscle strength and pulmonary function.
- Conditions
- Mastectomy
- Being tested
- Kinesiotaping, chest physical therapy
- Keywords
- kinesiotaping, pain, physiotherapy, pulmonary function, respiratory muscle strength, quality of life
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KinesiotapingOther
Participants will be seated on a chair, KT will be applied bilaterally at the end of the expiration on the fifth to sixth and ninth to tenth intercostal muscles transversally and on the anterior and posterior axillary line longitudinally with 50% tension. In order to stimulate the muscle and support the function, the stimulation technique is usually applied from the origin to the insertion of the muscle with the recommended stretching of 25 to 50%.
chest physical therapyOther
The chest physical therapy program is consisted of deep breathing exercises, postural drainage, and cough.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Kinesiotaping group) | Experimental | Participants will be seated on a chair, KT will be applied bilaterally at the end of the expiration on the fifth to sixth and ninth to tenth intercostal muscles transversally and on the anterior and posterior axillary line longitudinally with 50% tension. In order to stimulate the muscle and support the function, the stimulation technique is usually applied from the origin to the insertion of the muscle with the recommended stretching of 25 to 50%.
Additionally, traditional physical therapy program will be conducted to participants in the study group. Receives: Other: Kinesiotaping; Other: chest physical therapy |
| Group B (control group) | Active comparator | They will receive the chest physical therapy program which is consisted of deep breathing exercises, postural drainage, cough, 3 times /week for 4 weeks. Receives: Other: chest physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analogue scale
The visual representation of the pain range that a patient thinks they might experience is called a linear scale. The score is ranged from 0 to 10. The least the score, the better results. While, the higher the score, the worst the results.
Measured: 4 weeks
Secondary outcomes (5)
Forced vital capacity (FVC)
The forced vital capacity (FVC) will be measured by spirometer.
Measured: 4 weeks
forced expiratory volume at first second (FEV1)
forced expiratory volume at first second (FEV1) will be measured by spirometer.
Measured: 4 weeks
Forced expiratory volume at first second /Forced vital capacity ratio.
Forced expiratory volume at first second /Forced vital capacity ratio will be measured by spirometer.
Measured: 4 weeks
Respiratory muscle strength
Respiratory muscle strength will be measured by assessing the maximal inspiratory and maximal expiratory pressures (MIP) and maximal expiratory pressures (MEP).
Measured: 4 weeks
Quality of life
Quality of life will be measured by the Short Form-36 (SF-36). It is a questionnaire with eight subscales that gives information about the health status and quality of life of the person. Scores on each subscale range from 0 to 100, with 0 corresponding to the worst health status and 100 to the best health status.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start20 Dec 2024
- Primary completion30 Jun 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MastectomyStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nesma Morgan Allam, Cairo University
- Investigators
- Hadaya M Eladl, PhD, Study director, Assisstant professor of physical therapy for surgery, Faculty of physical therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06701591
- Sponsor's protocol ID
- No. 6905
- Status last verified
- Dec 2024
- First submitted
- 20 Nov 2024
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Elsherbini DMA, Eladl HM, Allam NM, Abulfaraj M, El-Sherbiny M, Nosseir N, Maghrabi A, Jamal W, Abdelrahman MMA, Eladl MA. Efficacy of combined Kinesio-taping with chest physiotherapy program on pain, pulmonary function, respiratory muscle strength and quality of life after mastectomy: a randomized controlled trial. Front Med (Lausanne). 2026 Jan 22;12:1664210. doi: 10.3389/fmed.2025.1664210. eCollection 2025.
PubMed 41657582
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Combined Kinesio-Taping With Chest Physiotherapy Program on Pain, Pulmonary Function, Respiratory Muscle Strength and Quality of Life After Mastectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06701591
- Acronym / sponsor ID
- No. 6905
- Conditions
- Mastectomy
- Keywords
- kinesiotaping, pain, physiotherapy, pulmonary function, respiratory muscle strength, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Dec 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 22 Nov 2024 (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.
The modified radical mastectomy (MRM) is a major surgical approach that necessitates the dissection of axillary lymph nodes. As a result, there is more bleeding and the treatment takes longer time. This treatment is used to treat locally advanced breast cancer. Numerous factors, including pain and respiratory depression from general anaesthesia, can impair respiratory function during the post-operative period. Pain causes the thoracic cage's post-operative movement to be restricted and the breathing muscles to become inhibited.
Detailed description
KT is a new technology that is being used in the treatment of post-surgical and respiratory problems, among other innovative evidence-based therapeutic options in patient care. Recently, this method is useful for treating a variety of sports-related and musculoskeletal disorders, as well as pain management. According to a small body of research on the usefulness and efficacy of KT in treating respiratory conditions in patients with chronic obstructive pulmonary disease (COPD), it can lead to improvements in respiratory muscle strength and pulmonary function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Kinesiotaping group) | Experimental | Other: Kinesiotaping, Other: chest physical therapyParticipants will be seated on a chair, KT will be applied bilaterally at the end of the expiration on the fifth to sixth and ninth to tenth intercostal muscles transversally and on the anterior and posterior axillary line longitudinally with 50% tension. In order to stimulate the muscle and support the function, the stimulation technique is usually applied from the origin to the insertion of the muscle with the recommended stretching of 25 to 50%. Additionally, traditional physical therapy program will be conducted to participants in the study group. |
| Group B (control group) | Active comparator | Other: chest physical therapyThey will receive the chest physical therapy program which is consisted of deep breathing exercises, postural drainage, cough, 3 times /week for 4 weeks. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Females aged between 30 and 50 years
- Participants after modified radical mastectomy
- Participants able to comprehend instructions.
- Cooperative participants, and willing to participate in the study.
Key exclusion criteria (9 listed)
- Participants having sensitive skin, scars, or lesions.
- Participants with unhealed incisions at the site of application.
- Participants with uncontrolled diabetes.
- Participants with deep vein thrombosis.
- Participants with previous chest diseases.
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 |
|---|---|---|
| KinesiotapingParticipants will be seated on a chair, KT will be applied bilaterally at the end of the expiration on the fifth to sixth and ninth to tenth intercostal muscles transversally and on the anterior and posterior axillary line longitudinally with 50% tension. In order to stimulate the muscle and support the function, the stimulation technique is usually applied from the origin to the insertion of the muscle with the recommended stretching of 25 to 50%. | Other | Group A (Kinesiotaping group) |
| chest physical therapyThe chest physical therapy program is consisted of deep breathing exercises, postural drainage, and cough. | Other | Group A (Kinesiotaping group), Group B (control group) |
Primary outcome
visual analogue scale
Time frame: 4 weeks
The visual representation of the pain range that a patient thinks they might experience is called a linear scale. The score is ranged from 0 to 10. The least the score, the better results. While, the higher the score, the worst the results.
5 secondary outcomes
Forced vital capacity (FVC)
Time frame: 4 weeks
forced expiratory volume at first second (FEV1)
Time frame: 4 weeks
Forced expiratory volume at first second /Forced vital capacity ratio.
Time frame: 4 weeks
Respiratory muscle strength
Time frame: 4 weeks
Quality of life
Time frame: 4 weeks
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 8 Aug 2025.
- Derived from this study: PubMed 41657582Elsherbini DMA, Eladl HM, Allam NM, Abulfaraj M, El-Sherbiny M, Nosseir N, Maghrabi A, Jamal W, Abdelrahman MMA, Eladl MA. Efficacy of combined Kinesio-taping with chest physiotherapy program on pain, pulmonary function, respiratory muscle strength and quality of life after mastectomy: a randomized controlled trial. Front Med (Lausanne). 2026 Jan 22;12:1664210. doi: 10.3389/fmed.2025.1664210. eCollection 2025.
- Individual participant dataSharing planned: Yes
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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.
Hadaya M Eladl, PhD study director
Assisstant professor of physical therapy for surgery, Faculty of physical therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesiotaping and chest physical therapy in people with Mastectomy, run by Cairo University at 1 site 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 4 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 8 Aug 2025. 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 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?
visual analogue scale (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 NCT06701591, which also lists 1 linked publication.
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 8 Aug 2025.