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

NCT02604030 | Completed

• 1 other identifier: 869.208
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Upper limb function

EXPERIMENTAL

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

Interventions

Upper limb function OTHER

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.

Also known as: Physiotherapy

Upper limb function

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal de Sao Carlos: lead

Study Sites (1)

School healthy unity of Federal University of Sao Carlos

São Carlos, São Paulo, 13.565-905, Brazil

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 24, 2015
• First Posted: November 13, 2015
• Study Start: August 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: January 31, 2017
• Last Updated: March 1, 2017

Record last verified: 2017-02

Locations

BR (1)