Risk Factors for Shoulder Joint Motion Restriction

May 25, 2022 updated by: Nilufer Kablan, Istanbul Medeniyet University

Risk Factors for Shoulder Joint Motion Restriction in Breast Cancer Survivors

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Istanbul Medeniyet University
        • Contact:
        • Principal Investigator:
          • Nilüfer Kablan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental Group
Breast cancer survivors with shoulder joint motion restriction
Other: measurement of tissue stiffness (N/m)
Stiffness values will be measured with myotonPro on centers of coordination located along the myofascial chain
Other: measurement of passive muscle tone (Hz)
muscle tones will be measured with myotonPro on centers of coordination located along along the myofascial chain
Other: measurement of creep of tissue
creep of tissue will be measured with myotonPro on centers of coordination located along the myofascial chain
Other: 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.
Other: measurement of skin temperature
measurements will be taken by the thermographic camera
Other: measurement of pain
Pain will be evaluated by visual analog scale (VAS)
Other: measurement of pain pressure threshold
Pain pressure threshold will be evaluated by a digital algometer
Other: measurement of grip strength
The grip strength of both hand will be evaluated by "hand-held" dynamometer.
Control group
Breast cancer survivors without shoulder joint motion restriction
Other: measurement of tissue stiffness (N/m)
Stiffness values will be measured with myotonPro on centers of coordination located along the myofascial chain
Other: measurement of passive muscle tone (Hz)
muscle tones will be measured with myotonPro on centers of coordination located along along the myofascial chain
Other: measurement of creep of tissue
creep of tissue will be measured with myotonPro on centers of coordination located along the myofascial chain
Other: 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.
Other: measurement of skin temperature
measurements will be taken by the thermographic camera
Other: measurement of pain
Pain will be evaluated by visual analog scale (VAS)
Other: measurement of pain pressure threshold
Pain pressure threshold will be evaluated by a digital algometer
Other: measurement of grip strength
The grip strength of both hand will be evaluated by "hand-held" dynamometer.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
measurement of tissue stiffness (N/m)
Time Frame: Baseline
Stiffness values will be measured with myotonPro on centers of coordination located along the myofascial chain
Baseline
measurement of passive muscle tone (Hz)
Time Frame: Baseline
muscle tones will be measured with myotonPro on centers of coordination located along the myofascial chain
Baseline
measurement of creep of tissue
Time Frame: Baseline
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
Time Frame: Baseline
The range of shoulder flexion, abduction, extension and external-internal rotation movements will be measured with a universal goniometer.
Baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
measurement of skin temperature
Time Frame: Baseline
measurements will be taken from the area covering 3 cm of the surgical incision with a P45 thermographic camera with high thermal sensitivity
Baseline
measurement of pain
Time Frame: Baseline
Pain will be evaluated by visual analog scale (VAS). In the scale, the patient is asked to mark the most appropriate pain intensity on a scale ranging from 0 (no pain) to 10 (tolerable pain). The higher the score, the greater the pain intensity.
Baseline
measurement of pain pressure threshold
Time Frame: Baseline
Pain pressure threshold will be evaluated by a digital algometer
Baseline
measurement of grip strength
Time Frame: Baseline
The grip strength of both hand will be evaluated by "hand-held" dynamometer.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul Medeniyet University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 15, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 15, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 18, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 18, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 23, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 31, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022/0226

Plan for Individual participant data (IPD)

Study Data/Documents

  1. Individual Participant Data Set
    Information identifier: 18192154
  2. Individual Participant Data Set
    Information identifier: 25977305
  3. Individual Participant Data Set
    Information identifier: 26079868
  4. Individual Participant Data Set
    Information identifier: 29332760
  5. Individual Participant Data Set
    Information identifier: 32031629
  6. Individual Participant Data Set
    Information identifier: 32767329
  7. Individual Participant Data Set

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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