Pilates Exercise Versus Proprioceptive Neuromuscular Facilitation in Shoulder Dysfunction Post Mastectomy

Not Applicable

Completed

• Conditions: Pilates; Proprioceptive Neuromuscular Fascilitation; Shoulder Dysfunction; Mastectomy

• Registration Number: NCT06652282
• Lead Sponsor: Cairo University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2023-11-01
• Primary Completion: 2024-03-01
• Study Completion: 2024-08-01
• Status Verified: 2024-10
• Study First Submitted: 2024-10-20
• Study First Submitted QC: 2024-10-21
• Last Update Submitted: 2024-10-21
• Study First Posted: 2024-10-22
• Last Update Posted: 2024-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
assessment of the change of shoulder range of motion using Software/Smartphone-based Goniometer	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 Outcome Measures

Name	Time	Method
Composite assessment of pain and disability using Shoulder pain and disability index	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

Trial Locations

Locations (1)

out-patient clinic, faculty of physical therapy, Cairo university; 🇪🇬 Giza, Egypt