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

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.

Study Overview

• Status: Completed
• Conditions: Shoulder Pain; Oncologic Complications; Exercise Therapy; Shoulder Syndrome
• Intervention / Treatment: Other: Scapular mobilization and Scapular strengthening exercises; Other: Conventional physical therapy program

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • New Cairo
    • Cairo, New Cairo, Egypt, 02
      • Shaimaa Mohamed Ahmed Elsayeh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 55 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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).	Other: 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.; 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.
ACTIVE_COMPARATOR: 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).	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Inclinometer reading before and after the treatment.	for measurement of shoulder flexion, abduction, external rotation, and scapular upward rotation	Baseline and four weeks after the intervention
Changes in Shoulder Pain and Disability Index (SPADI) before and after the treatment.	for measurement of shoulder disability	Baseline and four weeks after the intervention

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Shaimaa Elsayeh, PhD, Cairo University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2022
• Primary Completion (ACTUAL): June 28, 2022
• Study Completion (ACTUAL): July 20, 2022

Study Registration Dates

• First Submitted: September 2, 2022
• First Submitted That Met QC Criteria: September 6, 2022
• First Posted (ACTUAL): September 7, 2022

Study Record Updates

• Last Update Posted (ACTUAL): September 7, 2022
• Last Update Submitted That Met QC Criteria: September 6, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Mastectomy; Shoulder function; Scapular mobilization; Scapular strengthening exercises
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Shoulder Pain
• Other Study ID Numbers: P.T.REC/012/003464

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No