NCT06701591

Brief Summary

The modified radical mastectomy (MRM) is a major surgical approach that necessitates the dissection of axillary lymph nodes. As a result, there is more bleeding and the treatment takes longer time. This treatment is used to treat locally advanced breast cancer. Numerous factors, including pain and respiratory depression from general anaesthesia, can impair respiratory function during the post-operative period. Pain causes the thoracic cage's post-operative movement to be restricted and the breathing muscles to become inhibited.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 22, 2024

Completed
28 days until next milestone

Study Start

First participant enrolled

December 20, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2025

Completed
Last Updated

August 8, 2025

Status Verified

December 1, 2024

Enrollment Period

6 months

First QC Date

November 20, 2024

Last Update Submit

August 5, 2025

Conditions

Keywords

kinesiotapingpainphysiotherapypulmonary functionrespiratory muscle strengthquality of life

Outcome Measures

Primary Outcomes (1)

  • visual analogue scale

    The visual representation of the pain range that a patient thinks they might experience is called a linear scale. The score is ranged from 0 to 10. The least the score, the better results. While, the higher the score, the worst the results.

    4 weeks

Secondary Outcomes (5)

  • Forced vital capacity (FVC)

    4 weeks

  • forced expiratory volume at first second (FEV1)

    4 weeks

  • Forced expiratory volume at first second /Forced vital capacity ratio.

    4 weeks

  • Respiratory muscle strength

    4 weeks

  • Quality of life

    4 weeks

Study Arms (2)

Group A (Kinesiotaping group)

EXPERIMENTAL

Participants will be seated on a chair, KT will be applied bilaterally at the end of the expiration on the fifth to sixth and ninth to tenth intercostal muscles transversally and on the anterior and posterior axillary line longitudinally with 50% tension. In order to stimulate the muscle and support the function, the stimulation technique is usually applied from the origin to the insertion of the muscle with the recommended stretching of 25 to 50%. Additionally, traditional physical therapy program will be conducted to participants in the study group.

Other: KinesiotapingOther: chest physical therapy

Group B (control group)

ACTIVE COMPARATOR

They will receive the chest physical therapy program which is consisted of deep breathing exercises, postural drainage, cough, 3 times /week for 4 weeks.

Other: chest physical therapy

Interventions

Participants will be seated on a chair, KT will be applied bilaterally at the end of the expiration on the fifth to sixth and ninth to tenth intercostal muscles transversally and on the anterior and posterior axillary line longitudinally with 50% tension. In order to stimulate the muscle and support the function, the stimulation technique is usually applied from the origin to the insertion of the muscle with the recommended stretching of 25 to 50%.

Group A (Kinesiotaping group)

The chest physical therapy program is consisted of deep breathing exercises, postural drainage, and cough.

Group A (Kinesiotaping group)Group B (control group)

Eligibility Criteria

Age30 Years - 50 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Females aged between 30 and 50 years
  • Participants after modified radical mastectomy
  • Participants able to comprehend instructions.
  • Cooperative participants, and willing to participate in the study.

You may not qualify if:

  • Participants having sensitive skin, scars, or lesions.
  • Participants with unhealed incisions at the site of application.
  • Participants with uncontrolled diabetes.
  • Participants with deep vein thrombosis.
  • Participants with previous chest diseases.
  • Pregnancy.
  • Participants with altered sensations.
  • Participants with allodynia.
  • Participants with active infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of physical therapy

Giza, Giza Governorate, 1124, Egypt

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Hadaya M Eladl, PhD

    Assisstant professor of physical therapy for surgery, Faculty of physical therapy

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of physical therapy for surgery, Faculty of physical therapy

Study Record Dates

First Submitted

November 20, 2024

First Posted

November 22, 2024

Study Start

December 20, 2024

Primary Completion

June 30, 2025

Study Completion

July 30, 2025

Last Updated

August 8, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL
Time Frame
6 months after publication

Locations