Biofeedback Training on Shoulder Muscles Strength Post Mastectomy

Cairo University (CU)

Status: Completed

Conditions: Breast Cancer Female

Treatments: Procedure: Biofeedback device and other group control group; Procedure: Control group

Study type: Interventional

Funder types: Other

Identifiers

NCT06226688

202309250044 (Registry Identifier)

P.T.REC/012/004823

Details and patient eligibility

About

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?

Full 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

Enrollment: 54 patients

Sex: Female

Ages: 40 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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54 participants in 2 patient groups

Affected arm at the same side of mastectomy

Experimental group

Description:

There is 2 arms Arm1:-arm at side of mastectomy without lymphedema trained by biofeedback

Treatment:

Procedure: Control group

Procedure: Biofeedback device and other group control group

2 arms one trained by biofeedback and other control without biofeedback

Experimental group

Description:

Arm2:-arm at side of mastectomy on other group but not trained with biofeedback Training using shoulder ladder ,shoulder wheel ,shoulder mobilization and IPC

Treatment:

Procedure: Control group