Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05529680 |
Other study ID # |
P.T.REC/012/003464 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 1, 2022 |
Est. completion date |
July 20, 2022 |
Study information
Verified date |
September 2022 |
Source |
Cairo University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The most common complications following mastectomy are pain, lymphedema of the upper limb
ipsilateral to surgery, decreased range of motion (ROM), limited to 90° of flexion,
abduction, and external rotation to 40° of the shoulder, and postural changes. It was
reported that 60% of breast cancer patients show a reduction in shoulder flexion and
abduction at 1-month post-surgery and 10% of survivors show a persistent ROM reduction at 12
months. So, The purpose of the study was to evaluate the therapeutic impact of scapular
mobilization and strengthening exercises on shoulder function post-mastectomy.
Description:
In this randomized controlled trial study (RCT), forty female patients "The patient's ages
ranged from 40 to 55 years" suffering from post-mastectomy shoulder dysfunction ((20° ≥ ROM
limitation compared to the sound shoulder & 3 months to 6 months post mastectomy) were
randomly assigned into two equal groups, each one had 20 patients.
Group A (study group): This group included 20 patients with shoulder dysfunction
post-mastectomy who received scapular mobilization and strengthening exercise in addition to
their conventional physical therapy program for four weeks, three sessions/week.
Group B (control group): This group included 20 patients with shoulder dysfunction who
received conventional physical therapy programs in form of joint mobilization, posterior
capsule stretching, and range of motion exercise (ROM) for four weeks, 3 sessions/week.
Equipment and tools:
- Measurement tools were (The shoulder Pain and Disability Index (SPADI): for measurement
of shoulder disability and inclinometer: for measurement of shoulder flexion, abduction,
external rotation, and scapular upward rotation), the measurements were recorded before
and after the study.
- Therapeutic equipment and tools were (Thera Bands of different colors and resistance and
dumbbells of different weights).
The potential participants were excluded if they met any of the following criteria: Diseases
such as rheumatoid arthritis, history of trauma or accidental injuries, neurological
involvement (stroke, Parkinsonism), history of surgery on the involved shoulder, and diabetic
patient.