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.
