Clinical trial NCT06226688: Biofeedback Training on Shoulder Muscles Strength Post Mastectomy
Official title: Biofeedback Training on Shoulder Muscles Strength Post Mastectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Female
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-01-26
Enrollment: 54
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT 2 groups One of them control group And the other is study group
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Measure before and after shoulder muscles strength by hand held dynamometer
timeFrame: 6 wweks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Nourhan Souliman
state: Bahyea Foundation For Breast Cancer
city: Cairo
country: Egypt
facility: Nourhan Ahmed mahmoud souliman
Study officials:
affiliation: Research ethical commity
name: Research ethical commity Physical therapy Cairo university
role: PRINCIPAL_INVESTIGATOR
References: