Selected Exercise Program on Upper Cross Syndrome Post-unilateral Mastectomy

February 26, 2026 updated by: Vivian Samy Ayad Hana, Cairo University
The purpose of the study is to evaluate the therapeutic efficacy of exercise rehabilitation program on upper limb range and forward head posture post unilateral radical mastectomy.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Upper cross syndrome (forward head posture and rounded shoulder) is a major problem facing physical therapist, which causes an increase in pain, limitation of quality of life and delayed rehabilitation process.

The lack in knowledge and information in the published studies about effects of exercise program in forward head posture and rounded shoulder in female's management post unilateral mastectomy. This study will be carried out to investigate the effectiveness exercise program in improving the range of motion in shoulder and forward head posture in females post unilateral mastectomy.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Cairo, Egypt
        • Vivian Samy Ayad

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • The subject selection will be according to the following criteria:
  • Age range between 45-65years.
  • Females only will participate in the study.
  • All patients have upper cross syndrome post-unilateral modified radical mastectomy
  • All patients relatives enrolled the study will have their informed consent.

Exclusion Criteria:

  • Age more than 65 years or less than45 years.
  • Subjects who have hearing problems
  • Patients have acute viral diseases, acute tuberculosis, mental disorders or those with pacemakers.
  • Diabetic, cardiac and renal patients.
  • Genetic disease
  • Patients who had any other breast cancer operations

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Selected exercise program group
Patient will receive exercise program (stretching, strengthening and active range of motion (ROM) exercise) and routine medical treatment for 12 weeks.
Other: Selected exercise program
Patients who have upper cross syndrome post unilateral modified radical mastectomy and who will receive exercise program (strengthening, active range of motion exercise, and strengthening exercises including prone scapular stabilization, shoulders shrug McKenzie exercise for neck, repeated shoulder horizontal adduction, repeated shoulder flexion, repeated shoulder extension, neck flexion McKenzie exercises) and routine medical treatment. Patients will receive 3 sessions per week for 12weeks, time of session is 45 minutes.
Other Names:
  • Exercise program
Drug: Routine medical therapy

For pain relief:

Acetaminophen: 2 pills two times per day. Ibuprofen 400 mg: 1 pill two times per day.

Hormonal therapy:

Tamoxifen 20 mg: once daily. Silicone gel creams (Biocorneum): 3 times per day. These medications will be given for all patients throughout the treatment period (12 weeks).
Active Comparator: Routine medical treatment
Patients will receive routine medical treatment only for 12 weeks.
Drug: Routine medical therapy

For pain relief:

Acetaminophen: 2 pills two times per day. Ibuprofen 400 mg: 1 pill two times per day.

Hormonal therapy:

Tamoxifen 20 mg: once daily. Silicone gel creams (Biocorneum): 3 times per day. These medications will be given for all patients throughout the treatment period (12 weeks).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Craniovertebral angle (CVA)
Time Frame: 12 weeks

The Craniovertebral angle (CVA) is measured by creating an angle between a horizontal line passing through the seventh cervical (C7) vertebra and a line connecting C7 to the tragus of the ear. It is commonly used to assess forward head posture, with smaller angles indicating more severe forward head posture.

How to Measure the Craniovertebral Angle:

• Use software (KINOVEA) to draw a straight horizontal line passing through C7. Draw a second line connecting the C7 mark to the tragus of the ear. Measure the angle formed by these two lines (the acute angle).

  • Normal value of CVA: more than 50 degree.
  • Patients selected with CVA ranged between 30-50 degrees.
12 weeks
Cobb angle
Time Frame: 12 weeks

To measure the Cobb angle, identify the most tilted vertebrae at the top and bottom of a scoliosis curve on an X-ray (anteroposterior view).

Steps to Measure Cobb Angle:

  1. Identify End Vertebrae: Select the highest vertebra (upper end vertebra) and lowest vertebra (lower end vertebra) in the curve that are most tilted toward the concavity.

  2. Draw Parallel Lines:

    • Draw a line parallel to the superior (top) endplate of the upper vertebra.
    • Draw a line parallel to the inferior (bottom) endplate of the lower vertebra.
  3. Draw Perpendicular Lines: Draw a line perpendicular (90 degrees) to each of the lines drawn in step 2.
  4. Measure the Angle: The angle formed at the intersection of these two perpendicular lines is the Cobb angle.

A curve of more than or equal 10 degrees is defined as scoliosis.
12 weeks
The Functional Shoulder Score (FSS)
Time Frame: 12 weeks
The FSS is an 11-item patient-reported subjective outcome questionnaire consisting of two major categories - pain (one question) and activities of daily living (ADLs) (10 questions). Subjects will answer each question on a 10-point numeric rating scale, with a lower number always indicating worse pain or greater difficulty in function. The maximum score of 100 represents the total absence of pain and best possible function. The minimum score of 0 represents the worst possible result. Fifty points will be allocated for pain and 50 for ADLs. The final score will be calculated by multiplying the value indicated by the patient's answer to the question about pain by 5 and adding this to the half the sum of the total value recorded for ADLs.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Assessment of Cancer Therapy-Breast Quality-of- Life Instrument:
Time Frame: 12 weeks
The Functional Assessment of Cancer Therapy-Breast (FACT-B) is a widely used 37-item, self-report questionnaire designed to measure the quality of life (QoL) in breast cancer patients. It covers five domains-physical, social/family, emotional, and functional well-being, plus a Breast Cancer Subscale (BCS) addressing specific issues like body image and arm tenderness. It is a 5-point Likert scale (0-4: Not at all to Very much). Scores are summed, with negatively worded items reversed, to calculate subscales (Physical, Social, Emotional, Functional, and Breast Cancer-specific) and a total score (0-148), where higher scores indicate better quality of life.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Chair: Amal Abd El-Baky, Professor, Cairo University
  • Study Director: George Nashed, Professor, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 2, 2026

Primary Completion (Estimated)

June 7, 2026

Study Completion (Estimated)

June 15, 2026

Study Registration Dates

First Submitted

February 26, 2026

First Submitted That Met QC Criteria

February 26, 2026

First Posted (Actual)

March 3, 2026

Study Record Updates

Last Update Posted (Actual)

March 3, 2026

Last Update Submitted That Met QC Criteria

February 26, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012/004071

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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