Clinical trial NCT05932147: 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
Overall status: COMPLETED
Phase: NA
Conditions: Mastectomy; Lymphedema
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-07-06
Enrollment: 68
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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:

1. 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.

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:

  1. 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.

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

Primary outcomes:
measure: Electric Goniometer
timeFrame: 9 weeks
measure: DASH SCALE (Disability of arm, shoulder and hand)
timeFrame: 9 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Dokki
country: Egypt
facility: Cairo university of physical therapy
Study officials:
affiliation: Professor of Physical Therapy for Surgery
name: Prof. Dr. Haidy N Asham
role: STUDY_CHAIR
affiliation: Assistant professor of Physical Therapy for Surgery
name: Ass. Prof. Dr. Ereny S Wahba Khalil
role: STUDY_DIRECTOR
affiliation: Professor of Clinical Oncology
name: Prof. Dr. Mohamed A Hassan Abolkasem
role: PRINCIPAL_INVESTIGATOR
References: