Surgical Intervention and Physiotherapy in Breast Cancer: Effects in Scapular Kinematics, Pain and Upper Limb Function

February 28, 2017 updated by: Ivana Leão Ribeiro, Universidade Federal de Sao Carlos

Scapular Kinematics and Upper Limb Function in Women Who Had Undergone Breast Cancer Surgery Subjected to Upper Limb Stretching and Strengthening Exercises Program

Our objective is to identify the possible changes of three-dimensional scapula movement during arm elevation in women after breast cancer surgery and subjected to a physical therapy intervention. Also to evaluate pain, upper limb function and quality of life. Methods: Will be evaluated 25 women with a clinical diagnosis of breast cancer and 25 healthy controls women with no history of musculoskeletal disorders of upper limbs and matched with age and body mass index. Two pre-surgical evaluations in the month prior to surgical treatment of breast cancer and two post-surgical assessments are going to be assess: the first, after 4 weeks after surgery, when patients have received 8 sessions of physical therapy in upper limb; the second, after 8 weeks after surgery, when patients completed 16 sessions of physical therapy for shoulder complex . In each evaluation, bilateral scapular kinematics will be analyzed by an electromagnetic tracking device during arm elevation in scapula plane, in breast cancer group. Range of motion will by assessed by a digital inclinometer and muscle strength by a hand held dynamometer. Also, pain will be assessed by visual analog scale and upper limb function by DASH questionnaire. Quality of life is going to be evaluated by 36 questionnaire -item Short Form Health Survey (SF36).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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.

Detailed Description

The main disorders of upper limb related to postoperative breast cancer, as functional limitations and muscle weakness, have already been studied. Three-dimensional scapula movement can be altered after surgical treatment of this condition, but the studies are inconclusive on this topic. Objective: To identify the possible changes of three-dimensional scapula kinematics during arm elevation in women after breast cancer surgery and subjected to a physical therapy intervention. Also to evaluate pain, upper limb function and quality of life. Methods: Will be evaluated 25 women with a clinical diagnosis of breast cancer and 25 healthy controls women with no history of musculoskeletal disorders of upper limbs and matched with age and body mass index. There will be two pre-surgical evaluations in the month prior to surgical treatment of breast cancer (with an interval of one week between then) and two post-surgical assessments: the first, after 4 weeks after surgery, when patients have received 8 sessions (twice a week) of physical therapy in upper limb (passive mobilization in glenohumeral joint and scapular, scar massage, lymphatic drainage, stretching exercises); the second, after 8 weeks after surgery, when patients completed 16 sessions (twice a week) of physical therapy for shoulder complex (strengthening and stretching exercises). In each evaluation, bilateral scapular kinematics will be analyzed by an electromagnetic tracking device during arm lifting movement in scapula plane, in breast cancer group. For control group, the assessed side will be correspondent to dominant or non-dominant operated side. Flexion, abduction, external and internal rotation of each arm will be assessed by a digital inclinometer. Muscle strength of abductors and external rotators will be evaluated by a hand held dynamometer. Pain will be assessed by visual analog scale (VAS) and upper limb function will be assessed by Disabilities of the Arm and Shoulder and Hand (DASH) questionnaire. Quality of life, through the Medical Outcomes Study 36 questionnaire -item Short Form Health Survey (SF36). Statistical analysis will include analysis of qualitative and quantitative variables. Statistical tests will be applied according to the normality of the data and it will adopt a 5% of significance level for variables comparisons along evaluations. Expected results and clinical implications of the study: To provide information of shoulder and scapular biomechanics in women after surgery for breast cancer.

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.
Interventional

Enrollment (Actual)

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.
9

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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

Study Locations

  • Brazil
    • Sao Paulo
      • Sao Carlos, Sao Paulo, Brazil, 13.565-905
        • School healthy unity of Federal University of Sao Carlos

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Twenty five women with breast cancer diagnosis, more than 18 years and able to raise the arms after head level will be recruited.

Exclusion Criteria:

  • History of musculoskeletal disorders of upper limbs;
  • Recurrence of Breast Cancer;
  • Bilateral breast cancer;
  • Presence of lymphedema;
  • Metastasis diagnosis;
  • Attendance impact on shoulder, identified by positive tests: Hawkins - Kennedy; or shoulder injury prior to surgery, with signs and symptoms compatible with subacromial pain syndrome;
  • Previous history of surgery and fractures in upper limb;
  • Allergy to tape transpore, necessary to display the sensors during scapular kinematics assessment;
  • Body mass index (BMI ) greater que 28 kg/m², as can compromising data quality due to increased of subcutaneous tissue amount. This has been linked to an increase in the artifact in electromagnetic kinematic analysis signal.

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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: Upper limb function
Assessment of scapular kinematics during arm elevation, perceived function, quality of life, range of motion and muscle strength for shoulder complex after a rehabilitation program focused on upper limb.
Other: Upper limb function
Physical therapy program will be done in two steps, with 8 sessions each one (twice a week for four weeks). First, 8 sessions of passive mobilization in glenohumeral joint and scapular, scar massage, lymphatic drainage, stretching exercises will be completed. Second, 8 sessions of upper limb strengthening and stretching exercises for upper limb. Each session will be completed in 1 hour (twice a week) during two months.
Other Names:
  • Physiotherapy

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
Three-dimensional scapular kinematics angles scores.
Time Frame: 1 year
Three-dimensional scapular kinematics during arm elevation (scores are represented by movements of scapular angles at 30, 60, 90 and 120 degrees of humerus elevation).
1 year

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.
Universidade Federal de Sao Carlos

Study record dates

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Study Major Dates

Study Start (Actual)

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 1, 2015

Primary Completion (Actual)

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.
December 1, 2016

Study Completion (Actual)

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.
January 31, 2017

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).
August 24, 2015

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.
November 11, 2015

First Posted (Estimate)

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.
November 13, 2015

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.
March 1, 2017

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.
February 28, 2017

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.
February 1, 2017

More Information

Terms related to this study

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.
  • 869.208

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