Biofeedback Training on Shoulder Muscles Strength Post Mastectomy

Breast Cancer Female Clinical Trial

Official title:

Biofeedback Training on Shoulder Muscles Strength Post Mastectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06226688
• Other study ID #: P.T.REC/012/004823
• Secondary ID: 202309250044
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: May 9, 2024

Study information

• Verified date: May 2024
• Source: Cairo University
• Contact: Nourhan Ahmed mahmoud Souliman, Master
• Phone: 01112852496
• Email: na759273[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: May 9, 2024
• Est. primary completion date: May 5, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Female

Intervention

Procedure:
• Biofeedback device and other group control group
Intervention 1 :-Using the biofeedback device with dumble to strength affected arm post mastectomy
• Control group
Shoulder mobilization Shoulder ladder ex Shoulder wheel ex Ipc

Locations

Country	Name	City	State
Egypt	Nourhan Ahmed mahmoud souliman	Cairo
Egypt	Nourhan Souliman	Cairo	Bahyea Foundation For Breast Cancer

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure before and after shoulder muscles strength by hand held dynamometer	Measuring	6 wweks