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

Shoulder Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05529680
• Other study ID #: P.T.REC/012/003464
• Status: Completed
• Phase: N/A
• 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
• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 20, 2022
• Est. primary completion date: June 28, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Exercise Therapy
• Oncologic Complications
• Shoulder Pain
• Shoulder Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	Shaimaa Mohamed Ahmed Elsayeh	Cairo	New Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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