Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05932147
Other study ID # P.T.REC/012/003745
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 3, 2022
Est. completion date December 1, 2022

Study information

Verified date June 2023
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 68
Est. completion date December 1, 2022
Est. primary completion date September 4, 2022
Accepts healthy volunteers No
Gender Female
Age group 35 Years to 55 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Pilates exercise
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 massage
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.

Locations

Country Name City State
Egypt Cairo university of physical therapy Dokki

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Electric Goniometer for RANGE OF MOTION MEASURMENT 9 weeks
Primary DASH SCALE (Disability of arm, shoulder and hand) for disability measurement 9 weeks
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT05444361 - Ultrasound-Guided Percutaneous Cryoneurolysis to Treat Postoperative Pain After Mastectomy N/A
Completed NCT06321549 - New Era of DIEP With Minimally Invasive Mastectomy
Completed NCT04625621 - Breast Reconstruction by Exclusive Lipomodulin : Feasibility, Evaluation of the Aesthetic Result and Quality of Life
Not yet recruiting NCT06082206 - Pectoral Nerve Block Versus Paravertebral Block In The Incidence of Chronic Pain After Mastectomy: N/A
Completed NCT06415526 - OPERA - Incorporating Robotic Surgery in Both Mastectomy and DIEP Flap Reconstruction
Recruiting NCT04165525 - ConMed HelixAR™ ElectroSurgical Generator With Argon Beam Coagulation Technology Study N/A
Completed NCT05332028 - Ultrasound-guided Paravertebral Block Versus Mid-point Transverse Process Pleura Block in Mastectomy Surgery Phase 4
Not yet recruiting NCT05286489 - Effects of Selected Exercise Program on Microcirculation and Lymphedema in Postmastectomy Patients N/A
Completed NCT05761353 - Endermologie Versus Negative Pressure Therapy on Postmastectomy Lymphedema N/A
Enrolling by invitation NCT04943250 - Responses to Genetic Risk Modifier Testing Among Women With BRCA1/2 Mutations
Recruiting NCT04756791 - Prospective Comparison of Single-Injection Serratus Anterior Plane Block With Ropivacaine Versus Local Infiltration of Anaesthetic After Breast Surgery Phase 4
Not yet recruiting NCT06092892 - IIT2023-09-Chung-UpfrontTAD: Upfront TAD/SNB in Patients With Breast Cancer With Nodal Metastases Phase 2
Not yet recruiting NCT05914415 - The Effect of Preoperative Education on Postoperative Healing Quality in Patients With Mastectomy N/A
Completed NCT04166279 - The Recovery of Reaching Movement in Breast Cancer Survivors: Two Different Rehabilitative Protocols in Comparison N/A
Withdrawn NCT04246034 - Microvascular Breast Reconstruction With Lymph Node Transfer N/A
Completed NCT04184102 - .Exercise and Follow-up After a Mastectomy N/A
Recruiting NCT04233385 - Myofascial Massage for Pain and Immobility Following Breast Cancer Surgery N/A
Recruiting NCT04596683 - Same-Day Discharge After Nipple-sparing Mastectomy or Skin-sparing Mastectomy With Breast Reconstruction N/A
Completed NCT03764943 - Immunonutrition and Carbohydrate Loading Strategies in Breast Reconstruction Phase 3
Recruiting NCT05115799 - Effects of a Manual Therapy Program to Reduce the Evolution Time of Axillary Web Syndrome N/A