Clinical Trial With Two Physical Therapy Protocols After Breast Cancer Surgery and Immediate Reconstruction

Methods:

Patients will be recruited just after surgery scheduling. They will undergo preoperative evaluation one week before the surgery on average. At this moment, preoperative analysis will be conducted with personal data and medical history. Patients will undergo new assessments 07, 15, 30, 60, 90 and 180 days after surgery, periods that will be described as PO 07, PO 15, PO 30, PO 60, PO 90 and PO 180.

All patients will receive standard physiotherapy treatment for women undergoing breast reconstruction from Physical Therapy Sector of Mastology Discipline of the Department of Gynecology of Federal University of São Paulo. The protocol consists of early exercise, limited to 90° of shoulder range of motion (ROM), starting the day after the surgery and repeated 7 days after surgery.

After 15 days of surgery, the patients will be randomized into two treatment protocols.

However, because of the existence of different types of reconstructive surgery, randomization will performed from two groups:

• Alloplastic group: patients who will undergo reconstruction with tissue expander or breast implant
• Oncoplastic Group: patients who will undergo mammaplasty and / or contralateral symmetrization

Computer random sequence will be used for randomization, in which each group will be randomized to Group A or Group B.

• Subgroup A: Patients will start to perform exercises with free shoulder ROM. Patients will be told only to limit the movement if they feel pain.
• Subgroup B: Patient will keep shoulder exercises limited to 90° up to 30 days after surgery. At that moment (one month after surgery), then patients will also be allowed to move the shoulder with no restriction

At the end of randomization there will be four subgroups: alloplastic A, alloplastic B, oncoplastic A and oncoplastic B

Outcomes:

1. 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 extension, 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.

2. 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.

3. 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 difficulty to sleep and psychological commitment by reference to the week preceding the instrument application. The final score ranges from zero to one hundred, and the higher the score, the higher the upper limb dysfunction (arm, shoulder or hand).

4. 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.

5. 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.