NCT05529680

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2022

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 2, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 7, 2022

Completed
Last Updated

September 7, 2022

Status Verified

September 1, 2022

Enrollment Period

6 months

First QC Date

September 2, 2022

Last Update Submit

September 6, 2022

Conditions

Keywords

Scapular mobilizationScapular strengthening exercisesMastectomyShoulder function

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Scapular mobilization and strengthening exercise

EXPERIMENTAL

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 exercisesOther: Conventional physical therapy program

Conventional physical therapy program

ACTIVE COMPARATOR

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

Interventions

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.

Scapular mobilization and strengthening exercise

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 programScapular mobilization and strengthening exercise

Eligibility Criteria

Age40 Years - 55 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale patients
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaimaa Mohamed Ahmed Elsayeh

Cairo, New Cairo, 02, Egypt

Location

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Shaimaa Elsayeh, PhD

    Cairo University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
the patients were randomly assigned into two equal groups (20 patients for each group) by using the closed envelope method.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of physical therapy

Study Record Dates

First Submitted

September 2, 2022

First Posted

September 7, 2022

Study Start

January 1, 2022

Primary Completion

June 28, 2022

Study Completion

July 20, 2022

Last Updated

September 7, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations