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Physical therapy after breast cancer surgery and reconstruction

Randomized clinical trial with two physical therapy protocols after breast cancer surgery and immediate reconstruction

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-27gtnr
Enrollment
Unknown
Registered
2018-03-07
Start date
2015-06-23
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast cancer

Interventions

Patients will be recruited just after surgery scheduling. They will undergo preoperative evaluation. At this moment, preoperative analysis will be conducted with personal data and medical history. Pat
Procedure/surgery
E02.779

Sponsors

Universidade Federal de São Paulo - UNIFESP/EPM
Lead Sponsor
Samantha Karlla Lopes de Almeida Rizzi
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Women; older than 18 years; with breast cancer, who will be submitted to breast surgery (radical or conservative), followed by immediate reconstruction alloplastic (tissue expander or breast implant) or oncoplastic (breast reduction or contralateral symmetrization).

Exclusion criteria

Exclusion criteria: patients that will be submited to bilateral oncology surgery; patients that will be submited to reconstruction with autologous tissue or breast surgery without reconstruction; patients with motor or neurological deficits prior to surgery; patients with cognitive impairment; patients that do not accept to participate.

Design outcomes

Primary

MeasureTime frame
a) Shoulder range of motion: The shoulder ROM will be assessed with a goniometer for flexion, extension, adduction, abduction, internal rotation and external rotation. The movements will be performed actively. The patient will be positioned in the sitting position. To assess shoulder flexion, the upper limb will be in neutral position with elbow extension. Patient will be asked to raise the arm forward, close to the body. To assess extention, the arm will be positioned with 90° of elbow flexion and the patient will be asked to take the arm back. For adduction, the patient will be with 90° of shoulder flexion with the palm down and patient will be told to move the arm medially. For the study of the upper limb abduction, the limb will be in supination and elbow extension and the patient will be asked to raise the arm to the side, along the trunk line toward the ear. For the evaluation of internal rotation and external rotation the upper limb will be placed in 90° of shoulder abduction and 90° of elbow flexion. The patient will be asked to rotate the shoulder internally and externally, respectively. ;b) Pain: The pain will be evaluated with the Verbal Scale of Pain from zero to ten, where zero is no pain and ten is unbearable pain. The patient will be asked if there is pain at the moment of evaluation , and to describe the place and the degree of the pain.;c) Upper limbs function: To investigate the motor shoulder function DASH (Disabilities of the Arm, Shoulder and Hand Questionnaire) questionnaire will be used. It assesses the functional capacity in upper limb diseases and measures the skills to do certain activities, as well as the symptoms. It consists of 30 self-administered questions and two optional modules, for sports or musical activities and work activities. The 30 items evaluate the degree of difficulty in the performance of activities; the intensity of the symptoms of pain, weakness, stiffness and numbness; the commitment of social activities; the diffi

Secondary

MeasureTime frame
d) Dehiscence: Dehiscence wil be assessed by inspection and palpation. It will be described "presence" or "absence" of dehiscence and its location. The wound conditions will be described, with observation of necrosis and infection. Signs of infection such as redness, hyperthermia and secretion will be reported. The size of dehiscence will be described: in relation to the amount of opening points, in case of several opened points; or in centimeters (assessed per tape). Photographic record of dehiscence will be done, for better analysis and comparison of evolution. A Nikon Coolpix S3000 camera will be used. ;e) Seroma: The seroma evaluation will be performed by inspection and palpation. There will be description of "presence" or "absence" of seroma, location and the number of punctures made by the medical team and drained quantity, when necessary.;f) Axillary web syndrome: The axillary web syndrome evaluation will be performed with the patient in dorsal decubitus and upper limb homolateral to surgery on shoulder abduction at 90 degrees, external rotation of the shoulder and extension of the wrist and elbow. The physiotherapist will evaluate the presence of fibrous lymphatic cord by inspection and palpation. The number and location of the cords (axilla, trunk and arm) will be described.;g) Volumetry of upper limbs Volumetry will be performed through the perimetry and truncated cone formula. The perimetry will be performed with measures in centimeters of the circumference of the arm, to be performed with tape measure. For reference, measurements will be made starting from the flexion fold of the elbow, being 7 cm and 14 cm above this point and 7 cm, 14 cm and 21 cm below. All measurements will be performed with the upper limb in anatomical neutral position. The truncated cone formula will be used to transform perimetry into volumetry at each region between two perimetry measurements, thus obtaining the volume of the region. The volumes of each arm portion will

Countries

Brazil

Contacts

Public ContactSamantha Rizzi

Universidade Federal de São Paulo - UNIFESP/EPM

samyfisio@gmail.com+55(11)23067435

Outcome results

None listed

Source: REBEC (via WHO ICTRP)