Mastectomy; LymphedemaNCT05932147
Pilates Exercise Versus Manual Lymphatic Drainage On Axillary Web Syndrome Post Mastectomy
A study testing Pilates exercise and Manual lymphatic massage in people with Mastectomy; Lymphedema, run by Cairo University at 1 site in Egypt.
Trial summary
1-Subjects: Sixty-eight patients sample size according to G power who have Axillary web syndrome post mastectomy participated in this study. Their ages ranged from 35 to 55 years. Read more about this study
- Who is it for?
- Ages 35 to 55 years, women only
- Conditions the study is for
- Mastectomy; Lymphedema
- What is being tested?
- Pilates exercise and Manual lymphatic massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Jul 2022to 1 Dec 2022
- 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 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- • Age range between 35-55 years.
- Number of dissection of lymph nodes.
- No change of arm size.
- Females only will participate in the study.
- All patients have axillary web syndrome
- All patients' relatives enrolled to the study will have their informed consent
Who cannot join
- • Age more than 55 years or less than 35 years.
- Lymphedema.
- Chemotherapy and Radiotherapy.
- Pregnant women.
- Patients who suffer from mental or psychological problems.
- Patients who have psoriasis, liver disease, diabetes mellitus, hypertensive patients and cardiac problems
Show all 11Show fewer
- Patients have Genetic disease or deformity
- Who has previous injury or fracture in shoulder joint
- Rheumatoid arthritis
- Osteopenia
- Frozen shoulder
Trial locations and contacts
1 site in 1 country.
About this study
1-Subjects: Sixty-eight patients sample size according to G power who have Axillary web syndrome post mastectomy participated in this study. Their ages ranged from 35 to 55 years. The participants selected from learning hospitals (Al kasr Al Ayni hospital and National cancer institute) and randomly distributed into 2 equal groups.
1.1 Design of study: In this study the patients randomly assigned into two equal groups (34 patients for each group) 1.1(a) Group A: (Pilates Exercise)
Read more
1.1(b) Group B: (Manual Lymphatic Drainage)
- Equipment's and Tools: Equipment in this study divided into two main categories: measuring and therapeutic equipment.
2.1. Measuring Equipment:
The following tools are used to assess Range of motion and pain for shoulder joint:
2.1 (a) Measuring and assessment of pain by:
- Visual analogue scale 2.2 (b) Measuring range of motion (ROM) by:
- Electronic Goniometer 2.3 (c) Measuring Disability of the arm, shoulder and hand by:
- DASH questionnaire (Disability of the arm, shoulder and hand). 2.2. Therapeutic Equipment: 1. Pilates exercise 2- Manual lymphatic drainage 3. Procedures of the study:
The procedures of this study are classified into the following:
3.1 Measurement Procedures: All measurements have been taken before treatment (pre) after 9 weeks (post 1) after 9 weeks (post 2).
1.1 (a) Assessment of pain of shoulder joint
- Assessment of upper limb pain using visual analogue scale 3.1(b) Assessment of Range of motion of shoulder joint: By Electronic Goniometer. 3.1 (c) Assessment of Disability of the arm, shoulder and hand The disabilities of the arm, shoulder and hand questionnaire (DASH) 1.2 Therapeutic procedures: 3.2(a) procedures of Pilates exercise program:
- Shoulder Abduction with External Rotation exercise
- Shoulder bridge exercise
- Mermaid sitting exercise.
- Standing Pilates mermaid exercise with towel
- Rocking exercise
- Saw Pilates exercise.
- Bird-dog Pilates exercise.
- Roll up exercise.
- Cobra pose exercise.
- Child pose exercise.
Read the detailed description
1-Subjects: Sixty-eight patients sample size according to G power who have Axillary web syndrome post mastectomy participated in this study. Their ages ranged from 35 to 55 years. The participants have been selected from learning hospitals (Al kasr Al Ayni hospital and National cancer institute) and randomly distributed into 2 equal groups.
1.1 Design of study: In this study the patients randomly assigned into two equal groups (34 patients for each group) 1.1(a) Group A: (Pilates Exercise) This group includes 34 patients who have axillary web syndrome received Pilates exercise with traditional physical therapy exercise program (strength, core stability, flexibility, muscle control, posture and breathing). Patients will receive 3 sessions per week for 8 weeks; time of session is 30 minutes.
1.1(b) Group B: (Manual Lymphatic Drainage) This group includes 34 patients who axillary web syndrome received Manual lymphatic drainage massage with traditional physical therapy exercise program (strength, core stability, flexibility, muscle control, posture and breathing). Patients received 3 sessions per week for 8 weeks; time of session is 30 minutes.
- Equipment's and Tools: Equipment in this study divided into two main categories: measuring and therapeutic equipment.
2.1. Measuring Equipment:
The following tools are used to assess Range of motion and pain for shoulder joint:
2.1 (a) Measuring and assessment of pain by:
- Visual analogue scale 2.2 (b) Measuring range of motion (ROM) by:
- Electronic Goniometer 2.3 (c) Measuring Disability of the arm, shoulder and hand by:
- DASH questionnaire (Disability of the arm, shoulder and hand). 2.2. Therapeutic Equipment: 1. Pilates exercise
Parameters:
- Duration 30 minutes.
- Patient own choice with guidance.
- Suitable equipment chosen for specific situation.
- Measurement and follow up
- Three session per week
- For 9 weeks 2- Manual lymphatic drainage
Parameters:
- Duration 30 minutes.
- Patient own choice with guidance.
- Suitable equipment chosen for specific situation.
- Measurement and follow up
- Three session per week
- For 9 weeks 3. Procedures of the study:
The procedures of this study are classified into the following:
3.1 Measurement Procedures: All measurements have been taken before treatment (pre) after 9 weeks (post 1) after 9 weeks (post 2).
1.1 (a) Assessment of pain of shoulder joint
- Assessment of upper limb pain using visual analogue scale
- VAS will be used to assess the degree of pain intensity subjectively by same subject. This scale consists of 10cm line with the words "No Pain" on the right side.
3.1(b) Assessment of Range of motion of shoulder joint: By Electronic Goniometer.
- A standardized means of measuring and recording and a goniometer is aligned over a joint and with a click of a button the ROM measurement is entered automatically into E-LINK computer software, generating progress reports that can be utilized as definitive outcome measures. Goniometer to obtain goniometric measurements for shoulder flexion, abduction and external rotation will be used.
- Measuring of shoulder flexion range while patient is in supine position
- Measuring of shoulder abduction range while patient in sitting or supine position.
- Measuring of shoulder external rotation range while patient in supine position. 3.1 (c) Assessment of Disability of the arm, shoulder and hand The disabilities of the arm, shoulder and hand questionnaire (DASH)
- The disabilities of the arm, shoulder and hand (DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms.
- The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100 1.2 Therapeutic procedures: 3.2(a) procedures of Pilates exercise program:
- Shoulder Abduction with External Rotation exercise
- Shoulder bridge exercise
- Mermaid sitting exercise.
- Standing Pilates mermaid exercise with towel
- Rocking exercise
- Saw Pilates exercise.
- Bird-dog Pilates exercise.
- Roll up exercise.
- Cobra pose exercise.
- Child pose exercise.
- Conditions
- Mastectomy; Lymphedema
- Being tested
- Pilates exercise, Manual lymphatic massage
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilates exerciseOther
- Shoulder Abduction with External Rotation exercise
- Shoulder bridge exercise
- Mermaid sitting exercise.
- Standing Pilates mermaid exercise with towel
- Rocking exercise
- Saw Pilates exercise.
- Bird-dog Pilates exercise.
- Roll up exercise.
- Cobra pose exercise.
- Child pose exercise.
Manual lymphatic massageOther
procedures of Manual lymphatic drainage program Things to know about MLD Massage
- Use only gentle pressure, just enough to see your skin move.
- Massage should not be painful.
- Do not rub your skin red.
- Do massage each day.
- Repeat each step 5 to 10 times.
- The massage should take about 15 to 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Pilates group | Experimental | This group includes 34 patients who have axillary web syndrome will receive Pilates exercise with traditional physical therapy exercise program (strength, core stability, flexibility, muscle control, posture and breathing). Patients will receive 3 sessions per week for 9 weeks; time of session is 30 minutes. Receives: Other: Pilates exercise |
| Manual lymphatic massage group | Experimental | This group includes 34 patients who axillary web syndrome will receive Manual lymphatic drainage massage with traditional physical therapy exercise program (strength, core stability, flexibility, muscle control, posture and breathing). Patients will receive 3 sessions per week for 9 weeks; time of session is 30 minutes. Receives: Other: Manual lymphatic massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electric Goniometer
for RANGE OF MOTION MEASURMENT
Measured: 9 weeks
DASH SCALE (Disability of arm, shoulder and hand)
for disability measurement
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start3 Jul 2022
- Primary completion4 Sep 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mastectomy; LymphedemaStudies 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
- Model description
- Group A:( Pilates exercise) This group includes 34 patients who have axillary web syndrome received Pilates exercise with traditional physical therapy exercise program (strength, core stability, flexibility, muscle control, posture and breathing). Patients received 3 sessions per week for 8 weeks; time of session is 30 minutes. ) Group B: (Manual Lymphatic Drainage) This group includes 34 patients who axillary web syndrome received Manual lymphatic drainage massage with traditional physical therapy exercise program (strength, core stability, flexibility, muscle control, posture and breathing). Patients received 3 sessions per week for 8 weeks; time of session is 30 minutes.
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ORCHID SABER, Cairo University
- Investigators
- Prof. Dr. Haidy N Asham, Study chair, Professor of Physical Therapy for SurgeryAss. Prof. Dr. Ereny S Wahba Khalil, Study director, Assistant professor of Physical Therapy for SurgeryProf. Dr. Mohamed A Hassan Abolkasem, Principal investigator, Professor of Clinical Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05932147
- Sponsor's protocol ID
- P.T.REC/012/003745
- Status last verified
- Jun 2023
- First submitted
- 3 Jun 2023
- Last updated
- 6 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilates Exercise Versus Manual Lymphatic Drainage On Axillary Web Syndrome Post Mastectomy
- ClinicalTrials.gov ID
- NCT05932147
- Acronym / sponsor ID
- P.T.REC/012/003745
- Conditions
- Mastectomy; Lymphedema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 3 Jul 2022 (actual)
- Primary completion
- 4 Sep 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 6 Jul 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.
1-Subjects: Sixty-eight patients sample size according to G power who have Axillary web syndrome post mastectomy participated in this study. Their ages ranged from 35 to 55 years. The participants selected from learning hospitals (Al kasr Al Ayni hospital and National cancer institute) and randomly distributed into 2 equal groups.
1.1 Design of study: In this study the patients randomly assigned into two equal groups (34 patients for each group) 1.1(a) Group A: (Pilates Exercise)
1.1(b) Group B: (Manual Lymphatic Drainage)
- Equipment's and Tools: Equipment in this study divided into two main categories: measuring and therapeutic equipment.
2.1. Measuring Equipment:
The following tools are used to assess Range of motion and pain for shoulder joint:
2.1 (a) Measuring and assessment of pain by:
- Visual analogue scale 2.2 (b) Measuring range of motion (ROM) by:
- Electronic Goniometer 2.3 (c) Measuring Disability of the arm, shoulder and hand by:
- DASH questionnaire (Disability of the arm, shoulder and hand). 2.2. Therapeutic Equipment: 1. Pilates exercise 2- Manual lymphatic drainage 3. Procedures of the study:
The procedures of this study are classified into the following:
3.1 Measurement Procedures: All measurements have been taken before treatment (pre) after 9 weeks (post 1) after 9 weeks (post 2).
1.1 (a) Assessment of pain of shoulder joint
- Assessment of upper limb pain using visual analogue scale 3.1(b) Assessment of Range of motion of shoulder joint: By Electronic Goniometer. 3.1 (c) Assessment of Disability of the arm, shoulder and hand The disabilities of the arm, shoulder and hand questionnaire (DASH) 1.2 Therapeutic procedures: 3.2(a) procedures of Pilates exercise program:
- Shoulder Abduction with External Rotation exercise
- Shoulder bridge exercise
- Mermaid sitting exercise.
- Standing Pilates mermaid exercise with towel
- Rocking exercise
- Saw Pilates exercise.
- Bird-dog Pilates exercise.
- Roll up exercise.
- Cobra pose exercise.
- Child pose exercise.
Detailed description
1-Subjects: Sixty-eight patients sample size according to G power who have Axillary web syndrome post mastectomy participated in this study. Their ages ranged from 35 to 55 years. The participants have been selected from learning hospitals (Al kasr Al Ayni hospital and National cancer institute) and randomly distributed into 2 equal groups.
1.1 Design of study: In this study the patients randomly assigned into two equal groups (34 patients for each group) 1.1(a) Group A: (Pilates Exercise) This group includes 34 patients who have axillary web syndrome received Pilates exercise with traditional physical therapy exercise program (strength, core stability, flexibility, muscle control, posture and breathing). Patients will receive 3 sessions per week for 8 weeks; time of session is 30 minutes.
1.1(b) Group B: (Manual Lymphatic Drainage) This group includes 34 patients who axillary web syndrome received Manual lymphatic drainage massage with traditional physical therapy exercise program (strength, core stability, flexibility, muscle control, posture and breathing). Patients received 3 sessions per week for 8 weeks; time of session is 30 minutes.
- Equipment's and Tools: Equipment in this study divided into two main categories: measuring and therapeutic equipment.
2.1. Measuring Equipment:
The following tools are used to assess Range of motion and pain for shoulder joint:
2.1 (a) Measuring and assessment of pain by:
- Visual analogue scale 2.2 (b) Measuring range of motion (ROM) by:
- Electronic Goniometer 2.3 (c) Measuring Disability of the arm, shoulder and hand by:
- DASH questionnaire (Disability of the arm, shoulder and hand). 2.2. Therapeutic Equipment: 1. Pilates exercise
Parameters:
- Duration 30 minutes.
- Patient own choice with guidance.
- Suitable equipment chosen for specific situation.
- Measurement and follow up
- Three session per week
- For 9 weeks 2- Manual lymphatic drainage
Parameters:
- Duration 30 minutes.
- Patient own choice with guidance.
- Suitable equipment chosen for specific situation.
- Measurement and follow up
- Three session per week
- For 9 weeks 3. Procedures of the study:
The procedures of this study are classified into the following:
3.1 Measurement Procedures: All measurements have been taken before treatment (pre) after 9 weeks (post 1) after 9 weeks (post 2).
1.1 (a) Assessment of pain of shoulder joint
- Assessment of upper limb pain using visual analogue scale
- VAS will be used to assess the degree of pain intensity subjectively by same subject. This scale consists of 10cm line with the words "No Pain" on the right side.
3.1(b) Assessment of Range of motion of shoulder joint: By Electronic Goniometer.
- A standardized means of measuring and recording and a goniometer is aligned over a joint and with a click of a button the ROM measurement is entered automatically into E-LINK computer software, generating progress reports that can be utilized as definitive outcome measures. Goniometer to obtain goniometric measurements for shoulder flexion, abduction and external rotation will be used.
- Measuring of shoulder flexion range while patient is in supine position
- Measuring of shoulder abduction range while patient in sitting or supine position.
- Measuring of shoulder external rotation range while patient in supine position. 3.1 (c) Assessment of Disability of the arm, shoulder and hand The disabilities of the arm, shoulder and hand questionnaire (DASH)
- The disabilities of the arm, shoulder and hand (DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms.
- The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100 1.2 Therapeutic procedures: 3.2(a) procedures of Pilates exercise program:
- Shoulder Abduction with External Rotation exercise
- Shoulder bridge exercise
- Mermaid sitting exercise.
- Standing Pilates mermaid exercise with towel
- Rocking exercise
- Saw Pilates exercise.
- Bird-dog Pilates exercise.
- Roll up exercise.
- Cobra pose exercise.
- Child pose exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Group A:( Pilates exercise) This group includes 34 patients who have axillary web syndrome received Pilates exercise with traditional physical therapy exercise program (strength, core stability, flexibility, muscle control, posture and breathing). Patients received 3 sessions per week for 8 weeks; time of session is 30 minutes. ) Group B: (Manual Lymphatic Drainage) This group includes 34 patients who axillary web syndrome received Manual lymphatic drainage massage with traditional physical therapy exercise program (strength, core stability, flexibility, muscle control, posture and breathing). Patients received 3 sessions per week for 8 weeks; time of session is 30 minutes.
| Arm | Type | Receives |
|---|---|---|
| Pilates group | Experimental | Other: Pilates exerciseThis group includes 34 patients who have axillary web syndrome will receive Pilates exercise with traditional physical therapy exercise program (strength, core stability, flexibility, muscle control, posture and breathing). Patients will receive 3 sessions per week for 9 weeks; time of session is 30 minutes. |
| Manual lymphatic massage group | Experimental | Other: Manual lymphatic massageThis group includes 34 patients who axillary web syndrome will receive Manual lymphatic drainage massage with traditional physical therapy exercise program (strength, core stability, flexibility, muscle control, posture and breathing). Patients will receive 3 sessions per week for 9 weeks; time of session is 30 minutes. |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- • Age range between 35-55 years.
Key exclusion criteria (11 listed)
- • Age more than 55 years or less than 35 years.
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 |
|---|---|---|
| Pilates exercise1. Shoulder Abduction with External Rotation exercise 2. Shoulder bridge exercise 3. Mermaid sitting exercise. 4. Standing Pilates mermaid exercise with towel 5. Rocking exercise 6. Saw Pilates exercise. 7. Bird-dog Pilates exercise. 8. Roll up exercise. 9. Cobra pose exercise. 10. Child pose exercise. | Other | Pilates group |
| Manual lymphatic massageprocedures of Manual lymphatic drainage program Things to know about MLD Massage * Use only gentle pressure, just enough to see your skin move. * Massage should not be painful. * Do not rub your skin red. * Do massage each day. * Repeat each step 5 to 10 times. * The massage should take about 15 to 30 minutes. | Other | Manual lymphatic massage group |
Primary outcome
Electric Goniometer
Time frame: 9 weeks
for RANGE OF MOTION MEASURMENT
DASH SCALE (Disability of arm, shoulder and hand)
Time frame: 9 weeks
for disability measurement
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 6 Jul 2023.
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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.
Prof. Dr. Haidy N Asham study chair
Professor of Physical Therapy for Surgery
Ass. Prof. Dr. Ereny S Wahba Khalil study director
Assistant professor of Physical Therapy for Surgery
Prof. Dr. Mohamed A Hassan Abolkasem principal investigator
Professor of Clinical Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pilates exercise and Manual lymphatic massage in people with Mastectomy; Lymphedema, 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 6 inclusion and 11 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 Jul 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 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?
Electric Goniometer (time frame: 9 weeks). The study lists 2 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 6 Jul 2023; AzTrials last refreshed its copy on 6 Nov 2026.