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NCT Number: NCT07447024

Selected Exercise Program on Upper Cross Syndrome Post-unilateral Mastectomy

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.

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Key information

Conditions

Age range

45 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Vivian Samy Ayad

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

selected exercise program

Other

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

Routine medical therapy

Drug

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).

Primary outcomes

  1. 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.
  2. 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:

    • 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.
    • 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.
    • Draw Perpendicular Lines: Draw a line perpendicular (90 degrees) to each of the lines drawn in step 2.
    • 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.

  3. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ereny Khalil, Professor

CONTACT

[email protected]

01004037190

Vivian Hana, Master

CONTACT

[email protected]

01227288945

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 3, 2026
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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