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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02604030
• Other study ID #: 869.208
• Status: Completed
• Phase: N/A
• First received: August 24, 2015
• Last updated: February 28, 2017
• Start date: August 2015
• Est. completion date: January 31, 2017

Study information

• Verified date: February 2017
• Source: Universidade Federal de Sao Carlos
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: January 31, 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Brazil	School healthy unity of Federal University of Sao Carlos	Sao Carlos	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Sao Carlos

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Three-dimensional scapular kinematics angles scores.	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