Biofeedback Training on Shoulder Muscles Strength Post Mastectomy

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?

Study Overview

• Status: Completed
• Conditions: Breast Cancer Female
• Intervention / Treatment: Procedure: Biofeedback device and other group control group; Procedure: Control group

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 Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 02
    • Nourhan Ahmed mahmoud souliman
  • Bahyea Foundation For Breast Cancer
    • Cairo, Bahyea Foundation For Breast Cancer, Egypt, 02
      • Nourhan Souliman

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Affected arm at the same side of mastectomy; There is 2 arms Arm1:-arm at side of mastectomy without lymphedema trained by biofeedback	Procedure: Biofeedback device and other group control group; Intervention 1 :-Using the biofeedback device with dumble to strength affected arm post mastectomy; Other Names: Expirmental trial by biofeedback device; Procedure: Control group; Shoulder mobilization Shoulder ladder ex Shoulder wheel ex Ipc; Other Names: Intervention 2 :- using traditional PT programme without using biofeedback
Experimental: 2 arms one trained by biofeedback and other control without biofeedback; Arm2:-arm at side of mastectomy on other group but not trained with biofeedback Training using shoulder ladder ,shoulder wheel ,shoulder mobilization and IPC	Procedure: Control group; Shoulder mobilization Shoulder ladder ex Shoulder wheel ex Ipc; Other Names: Intervention 2 :- using traditional PT programme without using biofeedback

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure before and after shoulder muscles strength by hand held dynamometer	Measuring	6 wweks

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Research ethical commity Physical therapy Cairo university, Research ethical commity

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Actual): May 5, 2024
• Study Completion (Actual): May 9, 2024

Study Registration Dates

• First Submitted: January 14, 2024
• First Submitted That Met QC Criteria: January 18, 2024
• First Posted (Actual): January 26, 2024

Study Record Updates

• Last Update Posted (Actual): August 2, 2024
• Last Update Submitted That Met QC Criteria: July 31, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: P.T.REC/012/004823; 202309250044 (Registry Identifier: Baheya research center)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes