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Completed

NCT Number: NCT06652282

Pilates Exercise Versus Proprioceptive Neuromuscular Facilitation in Shoulder Dysfunction Post Mastectomy

The purpose of the study was done to evaluate the therapeutic efficacy of Pilates versus PNF in treatment of shoulder dysfunction and limitation of range of motion after mastectomy

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Key information

Conditions

Pilates Mastectomy Proprioceptive Neuromuscular Fascilitation Shoulder Dysfunction

Age range

40 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

out-patient clinic, faculty of physical therapy, Cairo university

Giza, Egypt

About this study

Mastectomy is the removal of the entire breast, with five types: simple or total mastectomy, modified radical mastectomy, radical mastectomy, partial mastectomy, and subcutaneous (nipple-sparing) mastectomy. Post-surgical pain and changes in breast shape can lead to side effects like wound infection, hematoma, seroma, shoulder pain, edema, and decreased range of motion. Mastectomy rates vary worldwide, with the highest rate in central and eastern Europe at 77%. Some women at high risk of breast cancer choose to have a mastectomy even when there's no sign of cancer.

Pilates improve flexibility, build strength, and develop control and endurance in the entire body. It emphasizes alignment, breathing, developing a strong core, and improving coordination and balance. The core, consisting of muscles of the abdomen, low back, and hips, is often called the "powerhouse" and is thought to be the key to a person's stability.

Proprioceptive Neuromuscular Facilitation (PNF) is a stretching technique used to improve muscle elasticity and has been shown to have a positive effect on active and passive range of motions.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Age range between 40-75 years.

  • Only females will participate in the study.
  • All patients have no diabetes or blood problems.
  • All patients enrolled to the study will have their informed consent

Exclusion criteria

Age less than 40 or more than 75 years.

  • Diabetes mellitus.
  • Subjects suffering from active malignant tumors.
  • Subjects treated with skin graft.
  • Subjects with Mental illness.
  • Subjects with skin diseases
  • Subjects with any previous cause for shoulder dysfunction

Treatment and study plan

Pilates exercises

Other

Before starting the training program, patients will learn key Pilates elements, including diaphragmatic breathing, neutral position, rib cage placement, shoulder placement, and head and neck placement. The exercise program includes Pilates-based mat exercises and Pilates-based theraband exercises, with patients placed in supine, prone, and kneeling positions to perform exercises for the affected shoulder. The patient will be placed in various positions for optimal results.

Proprioceptive Neuromuscular facilitation

Other

Before starting the training program, patients will learn key Pilates elements, including diaphragmatic breathing, neutral position, rib cage placement, shoulder placement, and head and neck placement. The exercise program includes Pilates-based mat exercises and Pilates-based theraband exercises, with patients placed in supine, prone, and kneeling positions to perform exercises for the affected shoulder. The patient will be placed in various positions for optimal results.

The conventional program

Other

Each patient was in the supine position and will receive stretching exercise for the flexors and adductors, and strengthening for the extensors, abductors and scapular stabilizers of the affected shoulder

Primary outcomes

  1. assessment of the change of shoulder range of motion using Software/Smartphone-based Goniometer

    Time frame: at baseline and 3 months

    Smartphones can be used as digital goniometers, offering benefits like convenience, ease of measurement, application-based tracking, and one-hand use. These applications use accelerometers to calculate joint angles. Patients with muscle issues, such as abduction and flexion, may experience reduced range of movement due to muscle bulk loss and bony leverage. However, these patients can compensate with the opposite arm, reducing the impact on daily activities.

Secondary outcomes

  1. Composite assessment of pain and disability using Shoulder pain and disability index

    Time frame: at baseline and 3 months

    It i used to determine the shoulder pain and disability. It comprises of 13 items: a 5-item subscale to evaluate the pain and an 8-item subscale to evaluate the disability. The total score is determined by averaging the pain and disability subscale scores.

    It exhibits great construct validity, associating admirably with other district explicit shoulder questionnaires

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Effect of Pilates Exercise Versus Proprioceptive Neuromuscular Facilitation in Shoulder Dysfunction Post Mastectomy

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 22, 2024
Registry last updated
Oct 22, 2024

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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