Impact of Scapular Mobilization And Strengthening Exercises on Shoulder Function Post Mastectomy

NCT ID: NCT05529680

Last Updated: 2022-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2022-07-20

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.

Conditions

Oncologic Complications; Exercise Therapy; Shoulder Pain; Shoulder Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Scapular mobilization and strengthening exercise

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 in form of joint mobilization, posterior capsule stretching and range of motion exercise (ROM).

Group Type: EXPERIMENTAL

Scapular mobilization and Scapular strengthening exercises

Intervention Type: OTHER

The intervention was applied for four weeks, 3 sessions/week. and the Shoulder Pain and Disability Index (SPADI): for measurement of shoulder disability and the Inclinometer: for measurement of shoulder flexion, abduction, external rotation, and scapular upward rotation were used for shoulder assessment before and after the intervention for both groups.

Conventional physical therapy program

Intervention Type: OTHER

The intervention was applied for four weeks, 3 sessions/week. and the Shoulder Pain and Disability Index (SPADI): for measurement of shoulder disability and the Inclinometer: for measurement of shoulder flexion, abduction, external rotation, and scapular upward rotation were used for shoulder assessment before and after the intervention for both groups.

Conventional physical therapy program

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).

Group Type: ACTIVE_COMPARATOR

Conventional physical therapy program

Intervention Type: OTHER

The intervention was applied for four weeks, 3 sessions/week. and the Shoulder Pain and Disability Index (SPADI): for measurement of shoulder disability and the Inclinometer: for measurement of shoulder flexion, abduction, external rotation, and scapular upward rotation were used for shoulder assessment before and after the intervention for both groups.

Interventions

Scapular mobilization and Scapular strengthening exercises

The intervention was applied for four weeks, 3 sessions/week. and the Shoulder Pain and Disability Index (SPADI): for measurement of shoulder disability and the Inclinometer: for measurement of shoulder flexion, abduction, external rotation, and scapular upward rotation were used for shoulder assessment before and after the intervention for both groups.

Intervention Type: OTHER

Conventional physical therapy program

The intervention was applied for four weeks, 3 sessions/week. and the Shoulder Pain and Disability Index (SPADI): for measurement of shoulder disability and the Inclinometer: for measurement of shoulder flexion, abduction, external rotation, and scapular upward rotation were used for shoulder assessment before and after the intervention for both groups.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Shaimaa Mohamed Ahmed Elsayeh

Lecturer of physical therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shaimaa Elsayeh, PhD

Role: STUDY_DIRECTOR

Cairo University

Locations

Shaimaa Mohamed Ahmed Elsayeh

Cairo, New Cairo, Egypt

Countries

Egypt

Other Identifiers

P.T.REC/012/003464

Identifier Type: -

Identifier Source: org_study_id