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

Primary Purpose

Oncologic Complications, Exercise Therapy, Shoulder Pain

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Scapular mobilization and Scapular strengthening exercises
Conventional physical therapy program
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oncologic Complications focused on measuring Scapular mobilization, Scapular strengthening exercises, Mastectomy, Shoulder function

Eligibility Criteria

40 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Shaimaa Mohamed Ahmed Elsayeh

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Scapular mobilization and strengthening exercise

Conventional physical therapy program

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

Changes in Inclinometer reading before and after the treatment.
for measurement of shoulder flexion, abduction, external rotation, and scapular upward rotation
Changes in Shoulder Pain and Disability Index (SPADI) before and after the treatment.
for measurement of shoulder disability

Secondary Outcome Measures

Full Information

First Posted
September 2, 2022
Last Updated
September 6, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05529680
Brief Title
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

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
June 28, 2022 (Actual)
Study Completion Date
July 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oncologic Complications, Exercise Therapy, Shoulder Pain, Shoulder Syndrome
Keywords
Scapular mobilization, Scapular strengthening exercises, Mastectomy, Shoulder function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Participant
Masking Description
the patients were randomly assigned into two equal groups (20 patients for each group) by using the closed envelope method.
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Scapular mobilization and strengthening exercise
Arm Type
Experimental
Arm Description
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).
Arm Title
Conventional physical therapy program
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Scapular mobilization and Scapular strengthening exercises
Intervention Description
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
Intervention Name(s)
Conventional physical therapy program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in Inclinometer reading before and after the treatment.
Description
for measurement of shoulder flexion, abduction, external rotation, and scapular upward rotation
Time Frame
Baseline and four weeks after the intervention
Title
Changes in Shoulder Pain and Disability Index (SPADI) before and after the treatment.
Description
for measurement of shoulder disability
Time Frame
Baseline and four weeks after the intervention

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
female patients
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shaimaa Elsayeh, PhD
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Shaimaa Mohamed Ahmed Elsayeh
City
Cairo
State/Province
New Cairo
ZIP/Postal Code
02
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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

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