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

NCT05932147 | Completed

• 1 other identifier: P.T.REC/012/003745
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Mastectomy; Lymphedema

Outcome Measures

Primary Outcomes (2)

• Electric Goniometer

  for RANGE OF MOTION MEASURMENT

  9 weeks

• DASH SCALE (Disability of arm, shoulder and hand)

  for disability measurement

  9 weeks

Study Arms (2)

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.

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.

Other: Manual lymphatic massage

Interventions

Pilates exercise OTHER

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.

Pilates group

Manual lymphatic massage OTHER

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.

Manual lymphatic massage group

Eligibility Criteria

• Age: 35 Years - 55 Years
• Gender Eligibility Details: Sixty-eight patients sample size according to G power who have Axillary web syndrome post mastectomy participated in this study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo university of physical therapy

Dokki, Egypt

Location

MeSH Terms

Conditions

Lymphedema

Interventions

Exercise Movement Techniques; Manual Lymphatic Drainage

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Therapeutics; Massage; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Drainage; Rehabilitation

Study Officials

• Prof. Dr. Haidy N Asham

  Professor of Physical Therapy for Surgery

  STUDY CHAIR

• Ass. Prof. Dr. Ereny S Wahba Khalil

  Assistant professor of Physical Therapy for Surgery

  STUDY DIRECTOR

• Prof. Dr. Mohamed A Hassan Abolkasem

  Professor of Clinical Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Model Details: 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.

Study Record Dates

• First Submitted: June 3, 2023
• First Posted: July 6, 2023
• Study Start: July 3, 2022
• Primary Completion: September 4, 2022
• Study Completion: December 1, 2022
• Last Updated: July 6, 2023

Record last verified: 2023-06

Locations

EG (1)