Biofeedback Training on Shoulder Muscles Strength Post Mastectomy

Not Applicable

Completed

• Conditions: Breast Cancer Female

• Registration Number: NCT06226688
• Lead Sponsor: Cairo University

Brief Summary

PURPOSE:The purpose of the study is to evaluate the effect of biofeedback on shoulder muscles strength post mastectomy.

BACKGROUND:

* The most common complications following mastectomy are pain, ipsilateral lymphedema of the upper limb (UL), reduced range of motion (ROM) of the shoulder, flexion and abduction is limited to 90°, and external rotation is limited to 40°, and there are postural changes

* One of the most common complications after breast cancer surgery is a functional limitation of the upper body. Up to 67% of breast cancer patients experience arm or shoulder impairment, including pain, numbness, loss of strength, and reduced ROM, after surgery

* Shoulder problems in breast cancer patients affect their daily activities, such as pulling a sweater overhead, fastening a bra, zipping up a back zipper, reaching overhead, and carrying heavy bags.

* Biofeedback is a mind-body technique in which individuals learn how to modify their physiology for the purpose of improving physical, mental, emotional and spiritual health. Much like physical therapy, biofeedback training requires active participation on the part of patients and often regular practice between training sessions. Clinical biofeedback may be used to manage disease symptoms as well as to improve overall health and wellness through stress management training. Research has shown that biofeedback interventions are efficacious in treating a variety of medical conditions, and many Americans are turning to biofeedback and other less traditional therapies for their (Dana et al., 2010).

HYPOTHESES: null hypothesis

RESEARCH QUESTION: Does biofeedback give effect on shoulder muscles strength post mastectomy?

Detailed Description

27 patient per group to G power 90% a Inclusion Criteria:

The subject selection will be according to the following criteria:

* Female patients with age range between 40-60 will participate in the study.

* All patients with their informed consent.

* All patients with unilateral mastectomy

* All patients have shoulder muscle weakness within 2 to 4 months post mastectomy

* All patients with chemo or radio therapy 1.2.b Exclusion Criteria:

The potential participants will be excluded if they meet one of the following criteria:

* metastasis

* Psychological Disorder

* Lymphedema

* Neurological or musculoskeletal disorders

Study Timeline

• Study Start: 2023-10-01
• Study First Submitted: 2024-01-14
• Study First Submitted QC: 2024-01-18
• Study First Posted: 2024-01-26
• Primary Completion: 2024-05-05
• Study Completion: 2024-05-09
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-31
• Last Update Posted: 2024-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 54

Inclusion Criteria

• The subject selection will be according to the following criteria:
• Female patients with age range between 40-60 will participate in the study.
• All patients with their informed consent.
• All patients with unilateral mastectomy
• All patients have shoulder muscle weakness within 2 to 4 months post mastectomy
• All patients with chemo or radio therapy

Exclusion Criteria

• The potential participants will be excluded if they meet one of the following criteria:
• metastasis
• Psychological Disorder
• Lymphedema
• Neurological or musculoskeletal disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Measure before and after shoulder muscles strength by hand held dynamometer	6 wweks	Measuring

Trial Locations

Locations (2)

Nourhan Souliman; 🇪🇬 Cairo, Bahyea Foundation For Breast Cancer, Egypt

Nourhan Ahmed mahmoud souliman; 🇪🇬 Cairo, Egypt