NCT05386641

Brief Summary

In breast cancer patients, limitation of shoulder joint movement may occur following cancer treatment. Shoulder limitation causes a significant decrease in the patient's participation in activities of daily living. The aim of the study is to define these limitations, to evaluate in detail all the structures that cause the problem, and to determine the causes of the limitations in patients with shoulder joint movement limitation developed after breast cancer survivors.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

May 18, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 23, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

August 15, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2024

Completed
Last Updated

May 31, 2022

Status Verified

May 1, 2022

Enrollment Period

1 year

First QC Date

May 18, 2022

Last Update Submit

May 25, 2022

Conditions

Keywords

breast cancerrange of motion

Outcome Measures

Primary Outcomes (4)

  • measurement of tissue stiffness (N/m)

    Stiffness values will be measured with myotonPro on centers of coordination located along the myofascial chain

    Baseline

  • measurement of passive muscle tone (Hz)

    muscle tones will be measured with myotonPro on centers of coordination located along the myofascial chain

    Baseline

  • measurement of creep of tissue

    creep of tissue will be measured with myotonPro on centers of coordination located along the myofascial chain

    Baseline

  • measurement of the range of shoulder joint motion

    The range of shoulder flexion, abduction, extension and external-internal rotation movements will be measured with a universal goniometer.

    Baseline

Secondary Outcomes (4)

  • measurement of skin temperature

    Baseline

  • measurement of pain

    Baseline

  • measurement of pain pressure threshold

    Baseline

  • measurement of grip strength

    Baseline

Study Arms (2)

Experimental Group

Breast cancer survivors with shoulder joint motion restriction

Other: measurement of tissue stiffness (N/m)Other: measurement of passive muscle tone (Hz)Other: measurement of creep of tissueOther: measurement of the range of shoulder joint motionOther: measurement of skin temperatureOther: measurement of painOther: measurement of pain pressure thresholdOther: measurement of grip strength

Control group

Breast cancer survivors without shoulder joint motion restriction

Other: measurement of tissue stiffness (N/m)Other: measurement of passive muscle tone (Hz)Other: measurement of creep of tissueOther: measurement of the range of shoulder joint motionOther: measurement of skin temperatureOther: measurement of painOther: measurement of pain pressure thresholdOther: measurement of grip strength

Interventions

Stiffness values will be measured with myotonPro on centers of coordination located along the myofascial chain

Control groupExperimental Group

muscle tones will be measured with myotonPro on centers of coordination located along along the myofascial chain

Control groupExperimental Group

creep of tissue will be measured with myotonPro on centers of coordination located along the myofascial chain

Control groupExperimental Group

The range of shoulder flexion, abduction, extension and external-internal rotation movements will be measured with a universal goniometer.

Control groupExperimental Group

measurements will be taken by the thermographic camera

Control groupExperimental Group

Pain will be evaluated by visual analog scale (VAS)

Control groupExperimental Group

Pain pressure threshold will be evaluated by a digital algometer

Control groupExperimental Group

The grip strength of both hand will be evaluated by "hand-held" dynamometer.

Control groupExperimental Group

Eligibility Criteria

Age30 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsbreast cancer survivors
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Breast cancer survivors with or without shoulder joint restriction will be evaluated

You may qualify if:

  • Women between the ages of 30-60
  • Having breast cancer treatment within 5 years

You may not qualify if:

  • Not having agreed to participate in the study
  • Presence of additional orthopedic (scoliosis, etc.), neurological (multiple sclerosis, stroke, etc.) and rheumatological diseases (ankylosing spondylitis, rheumatoid arthritis, etc.) that will affect upper extremity functions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İstanbul Medeniyet University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Nilüfer Kablan, PhD

CONTACT

Gülser Cinbaz, MSc

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 18, 2022

First Posted

May 23, 2022

Study Start

August 15, 2022

Primary Completion

August 15, 2023

Study Completion

February 15, 2024

Last Updated

May 31, 2022

Record last verified: 2022-05

Locations