Pilates Exercise Versus Proprioceptive Neuromuscular Facilitation in Shoulder Dysfunction Post Mastectomy

Effect of 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

Study Overview

• Status: Completed
• Conditions: Mastectomy; Pilates; Shoulder Dysfunction; Proprioceptive Neuromuscular Fascilitation
• Intervention / Treatment: Other: Pilates exercises; Other: proprioceptive neuromuscular facilitation; Other: The conventional program

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt
    • out-patient clinic, faculty of physical therapy, Cairo university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pilates exercise; This group includes 20 patients who had mastectomy and will recieve Pilates exercise in addition to conventional physical therapy program (stretching exercises and strengthening exercises), and routine medical treatment. Patients will receive 3 sessions per week for 12 weeks, time of session is 45 - 60 min according to patient ability	Other: Pilates exercises; 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.
Active Comparator: proprioceptive neuromuscular facilitation (PNF); This group includes 20 patients who had mastectomy and will receive PNF exercise in addition to conventional physical therapy program (stretching exercises and strengthening exercises) and routine medical treatment. Patients will receive 3 sessions per week for 12 weeks, time of session is 45 - 60 min according to patient ability	Other: proprioceptive neuromuscular facilitation; 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.
Active Comparator: Conventional exercise; This group includes 20 patients who had mastectomy and will receive conventional physical therapy program (stretching exercises and strengthening exercises) and routine medical treatment. Patients will receive 3 sessions per week for 12 weeks, time of session is 45 - 60 min according to patient ability	Other: The conventional program; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
assessment of the change of shoulder range of motion using Software/Smartphone-based Goniometer	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.	at baseline and 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite assessment of pain and disability using Shoulder pain and disability index	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	at baseline and 3 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Actual): March 1, 2024
• Study Completion (Actual): August 1, 2024

Study Registration Dates

• First Submitted: October 20, 2024
• First Submitted That Met QC Criteria: October 21, 2024
• First Posted (Actual): October 22, 2024

Study Record Updates

• Last Update Posted (Actual): October 22, 2024
• Last Update Submitted That Met QC Criteria: October 21, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Ahmed-005293

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No