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Pilates Exercise Versus Manual Lymphatic Drainage On Axillary Web Syndrome Post Mastectomy

Primary Purpose

Mastectomy; Lymphedema

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Pilates exercise
Manual lymphatic massage
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mastectomy; Lymphedema

Eligibility Criteria

35 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: • 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 Exclusion Criteria: • 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 Patients have Genetic disease or deformity Who has previous injury or fracture in shoulder joint Rheumatoid arthritis Osteopenia Frozen shoulder

Sites / Locations

  • Cairo university of physical therapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Pilates group

Manual lymphatic massage group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Electric Goniometer
for RANGE OF MOTION MEASURMENT
DASH SCALE (Disability of arm, shoulder and hand)
for disability measurement

Secondary Outcome Measures

Full Information

First Posted
June 3, 2023
Last Updated
June 27, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05932147
Brief Title
Pilates Exercise Versus Manual Lymphatic Drainage On Axillary Web Syndrome Post Mastectomy
Official Title
Pilates Exercise Versus Manual Lymphatic Drainage On Axillary Web Syndrome Post Mastectomy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
July 3, 2022 (Actual)
Primary Completion Date
September 4, 2022 (Actual)
Study Completion Date
December 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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) 2. 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. 2. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mastectomy; Lymphedema

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pilates group
Arm Type
Experimental
Arm Description
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.
Arm Title
Manual lymphatic massage group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Pilates exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Manual lymphatic massage
Intervention Description
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.
Primary Outcome Measure Information:
Title
Electric Goniometer
Description
for RANGE OF MOTION MEASURMENT
Time Frame
9 weeks
Title
DASH SCALE (Disability of arm, shoulder and hand)
Description
for disability measurement
Time Frame
9 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Sixty-eight patients sample size according to G power who have Axillary web syndrome post mastectomy participated in this study.
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • 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 Exclusion Criteria: • 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 Patients have Genetic disease or deformity Who has previous injury or fracture in shoulder joint Rheumatoid arthritis Osteopenia Frozen shoulder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof. Dr. Haidy N Asham
Organizational Affiliation
Professor of Physical Therapy for Surgery
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ass. Prof. Dr. Ereny S Wahba Khalil
Organizational Affiliation
Assistant professor of Physical Therapy for Surgery
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Prof. Dr. Mohamed A Hassan Abolkasem
Organizational Affiliation
Professor of Clinical Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo university of physical therapy
City
Dokki
Country
Egypt

12. IPD Sharing Statement

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Pilates Exercise Versus Manual Lymphatic Drainage On Axillary Web Syndrome Post Mastectomy

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