Scapular PNF and Activity Oriented Antiedema Proprioceptive Therapy on Shoulder Dysfunction Post Matectomy Lymphedema

NCT06602180 | Completed DMC

• 1 other identifier: 152427
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

Ninety -three female patients suffering from shoulder dysfunction after breast cancer-related arm lymphedema, will National Cancer Institute (Cairo university) be randomly distributed into three groups equal in number.

Conditions

Upper Limb Edema

Outcome Measures

Primary Outcomes (3)

• Cone formula for lymphedema assessment

  the truncated cone formula. V = h C12 + C1C2 + C22 =12 (where V = extremity volume, h = height, C1 = circumference of the top of the cone, C2 = circumference of the base of the cone) as both extremities will be measured from the wrist to the top of the arm (axillary fold) at 4-cm intervals

  three months

• Digital inclinometer for scapular range and shoulder range assessment

  The digital inclinometer demonstrates moderate to excellent reliability in evaluating both shoulder and scapular range in case of shoulder disorder

  three months

• Upper limb function/activity performance: Measured with e Quick Disabilities of the Arm, Shoulder and Hand (Quick-DASH):

  The arm, shoulder, and hand problems quick questionnaire (Quick-Dash) used to evaluate the symptom severity and functional capacity of the patients

  three months

Study Arms (3)

Exprimental group A

EXPERIMENTAL

Thirty-one patients will receive: Scapular PNF technique, (TAPA) technique for the affected shoulder region plus conventional physiotherapy program in a form of (CDT).

Other: Scapular PNF technique, (TAPA) technique for the affected shoulder region plus conventional physiotherapy program in a form of (Complex decongestive therapy (CDT).

Experimental: group B

EXPERIMENTAL

Thirty-one patients will receive Scapular PNF technique for the affected shoulder region plus conventional physiotherapy program in a form of (Complex decongestive therapy (CDT))

Other: Scapular PNF technique for the affected shoulder region plus conventional physiotherapy program in a form of (Complex decongestive therapy (CDT))

Experimental: group C:

EXPERIMENTAL

Thirty-one patients will receive Activity-Oriented Antiedema Proprioceptive Therapy (TAPA) technique for the affected shoulder region plus conventional physiotherapy program in a form of (Complex decongestive therapy (CDT)

Other: Activity-Oriented Antiedema Proprioceptive Therapy (TAPA) technique for the affected shoulder region plus conventional physiotherapy program in a form of (Complex decongestive therapy (CDT)

Interventions

Scapular PNF technique, (TAPA) technique for the affected shoulder region plus conventional physiotherapy program in a form of (Complex decongestive therapy (CDT). OTHER

Complex or combined decongestive physical therapy (CDT): skin care and patient education, manual lymphatic drainage MLD, joints exercises, and compression garments. Scapular PNF: Proprioceptive Neuromuscular Facilitation (PNF) is treatment approach that focus on motor learning, helps the patient to relax, improves coordination, and normalizes the motion. The repeated contractions technique increases active range of motion and strength and guides the patient's motion towards the desired motion, TAPA involves an intervention protocol composed of: 10-min neuro dynamics oriented to the activity 10-min proprioceptive neuromuscular facilitation activities. 10-min proprioceptive anti-edema bandaging, including patient and/or caretaker instructions for placement, as well as assistance on techniques to use for performing everyday activities,

Exprimental group A

Scapular PNF technique for the affected shoulder region plus conventional physiotherapy program in a form of (Complex decongestive therapy (CDT)) OTHER

Proprioceptive Neuromuscular Facilitation (PNF) is treatment approach that focus on motor learning, helps the patient to relax, improves coordination, and normalizes the motion. The repeated contractions technique increases active range of motion and strength and guides the patient's motion towards the desired motion, Complex or combined decongestive physical therapy (CDT): skin care and patient education, manual lymphatic drainage MLD, joints exercises, and compression garments

Experimental: group B

Activity-Oriented Antiedema Proprioceptive Therapy (TAPA) technique for the affected shoulder region plus conventional physiotherapy program in a form of (Complex decongestive therapy (CDT) OTHER

Activity-Oriented Proprioceptive Antiedema Therapy TAPA: TAPA involves an intervention protocol composed of: * 10-min neuro dynamics oriented to the activity * 10-min proprioceptive neuromuscular facilitation activities. * 10-min proprioceptive anti-edema bandaging, including patient and/or caretaker instructions for placement, as well as assistance on techniques to use for performing everyday activities, Complex or combined decongestive physical therapy (CDT): skin care and patient education, manual lymphatic drainage MLD, joints exercises, and compression garments

Experimental: group C:

Eligibility Criteria

• Age: 40 Years - 60 Years
• Gender Eligibility Details: Only female patients will participate in the study
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• The subject selection will be according to the following criteria:
• Age range between 40-60 years.
• Only female patients will participate in the study.
• All female patients diagnosed as unilateral breast cancer.
• All Female patients operated on for BC with BCRL in stages I and II.
• All female patients suffering from shoulder dysfunction after breast cancer-related arm lymphedema.
• All patients enrolled to the study will have their informed consent.

You may not qualify if:

• The potential participants will be excluded if they meet one of the following criteria:
• Patients with health problems, diseases or dysfunctions that prevented them from participating in the intervention.
• Patients with bilateral lymphedema.
• Patients with previous primary lymphedema.
• Patients with metastasis.
• Patients whom staging was not possible due to atypical findings or poor image.
• Patients with active arm infection.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy

Cairo, 2222, Egypt

Location

MeSH Terms

Interventions

tapasin; Methods; carbohydrate-deficient transferrin

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• rasha ahmed, master

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double : participant ,investigator
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master of physical therapy

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: September 19, 2024
• Study Start: September 20, 2024
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: June 8, 2025

Record last verified: 2025-06

Locations

EG (1)