Clinical trial NCT05529680: Impact of Scapular Mobilization And Strengthening Exercises on Shoulder Function Post Mastectomy
Official title: Impact of Scapular Mobilization And Strengthening Exercises on Shoulder Function Post Mastectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oncologic Complications
Exercise Therapy
Shoulder Pain
Shoulder Syndrome
Keywords: Scapular mobilization
Scapular strengthening exercises
Mastectomy
Shoulder function
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-09-07
Enrollment: 40
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Forty patients suffering from post-mastectomy shoulder dysfunction were randomly assigned into two equal groups each one has 20 patients.

Group A (study group): Who received scapular mobilization and strengthening exercises in addition to their conventional physical therapy program.

Group B (control group): Who received a conventional physical therapy program in form of joint mobilization, posterior capsule stretching, and range of motion exercise.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Female patients with ages ranging from 40-55 years.
* All patients had shoulder dysfunction post-mastectomy (20° ≥ ROM limitation compared to the sound shoulder).
* Patients were 3 months to 6 months post-mastectomy.
* All enrolled patients signed the informed consent.

Exclusion Criteria:

* Disease such as rheumatoid arthritis.
* History of trauma or accidental injuries.
* Neurological involvement (stroke, Parkinsonism).
* History of surgery on the involved shoulder.
* Diabetic patient.

Primary outcomes:
measure: Changes in Inclinometer reading before and after the treatment.
timeFrame: Baseline and four weeks after the intervention
measure: Changes in Shoulder Pain and Disability Index (SPADI) before and after the treatment.
timeFrame: Baseline and four weeks after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Shaimaa Mohamed Ahmed Elsayeh
state: New Cairo
Study officials:
affiliation: Cairo University
name: Shaimaa Elsayeh, PhD
role: STUDY_DIRECTOR
References: