跳至主要内容
临床试验/NCT02480842
NCT02480842已完成不适用

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

Federal University of São Paulo2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2015年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
2
主要终点
Change in shoulder range of motion from preoperative assessment (one week before surgery on average) at 30 days after surgery assessment

研究概览

简要总结

Introduction: physical therapy is essential in preventing motor and functional complications after breast cancer surgery. However, there is no prospective randomized study of different physiotherapy approaches in patients undergoing breast cancer surgery with immediate reconstruction. Objectives: to evaluate two physical therapy protocols in patients after breast cancer surgery with immediate reconstruction. A group with shoulder exercises with limited range of motion (ROM) at 90 degrees up to a month after surgery and a group with limited ROM only up to 15 days after surgery. Specific objectives: to evaluate shoulder ROM and pain one week before the surgery on average, and 07, 15, 30, 60, 90 and 180 days after surgery; assess motor function one week before the surgery on average, and 30 and 90 days after surgery; evaluate dehiscence and seroma 07, 15, 30, 60 and 90 days after surgery; associate incidence of seroma and dehiscence with preoperative risk factors and compare all variables (shoulder ROM, pain, motor function, seroma and dehiscence) between the two groups. Methods: women 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) will be included. Patients that will be submitted to bilateral oncology surgery, reconstruction with autologous tissue or breast surgery without reconstruction will not be included. Patients will be recruited just after surgery scheduling and will undergo preoperative evaluation. 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. All patients will receive standard physiotherapy treatment for women undergoing breast reconstruction from Physical Therapy Sector. The protocol consists of early exercise, limited to 90° of shoulder 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. One group will start to perform exercises with free shoulder ROM. Patients will be told only to limit the movement if they feel pain. The other group will keep shoulder exercises limited to 90° up to 30 days after surgery. At that moment (one month after surgery), they will also be allowed to move the shoulder with no restriction. The evaluation of the presence of dehiscence and seroma will occur by inspection and palpation. Shoulder ROM will be investigated through active goniometry of flexion, extension, adduction, abduction, internal rotation and external rotation. The pain will be assessed with the Verbal Numerical Scale from 0 to10 and upper limb function through the DASH (Disabilities of the Arm, Shoulder and Hand Questionnaire) questionnaire.

详细描述

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:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women 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).

排除标准

  • Patients that will be submitted to bilateral oncology surgery, reconstruction with autologous tissue or breast surgery without reconstruction. Patients with motor or neurological deficits prior to surgery, with cognitive impairment and those that do not accept to participate.
  • Patients who need to undergo new surgical procedures during the postoperative follow-up period and those who do not appear to postoperative evaluations

研究组 & 干预措施

Alloplastic group A

Experimental

After randomization (15 days after surgery):

  • Patients will start to perform exercises with free shoulder ROM. Patients will be told only to limit the movement if they feel pain.

干预措施: Alloplastic free ROM (Other)

Alloplastic group B

Experimental

After randomization (15 days after surgery):

  • Patients 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

干预措施: Alloplastic limited ROM (Other)

Oncoplastic group A

Experimental

After randomization (15 days after surgery):

  • Patients will start to perform exercises with free shoulder ROM. Patients will be told only to limit the movement if they feel pain.

干预措施: Oncoplastic free ROM (Other)

Oncoplastic group B

Experimental

After randomization (15 days after surgery):

  • Patients 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

干预措施: Oncoplastic limited ROM (Other)

结局指标

主要结局

Change in shoulder range of motion from preoperative assessment (one week before surgery on average) at 30 days after surgery assessment

时间窗: One week before surgery on average and 30 days after surgery

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.

Change in shoulder range of motion from preoperative assessment (one week before surgery on average) at 15 days after surgery assessment

时间窗: One week before surgery on average and 15 days after surgery

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.

Change in shoulder range of motion from preoperative assessment (one week before surgery on average) at 07 days after surgery assessment

时间窗: One week before surgery on average and 07 days after surgery

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.

Change in shoulder range of motion from preoperative assessment (one week before surgery on average) at 60 days after surgery assessment

时间窗: One week before surgery on average and 60 days after surgery

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.

Change in shoulder range of motion from preoperative assessment (one week before surgery on average) at 90 days after surgery assessment

时间窗: One week before surgery on average and 90 days after surgery

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.

Change in shoulder range of motion from preoperative assessment (one week before surgery on average) at 180 days after surgery assessment

时间窗: One week before surgery on average and 180 days after surgery

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.

次要结局

  • Change in self reported pain intensity from preoperative assessment (one week before surgery on average) at 15 days after surgery assessment(One week before surgery on average and 15 days after surgery)
  • Change in self reported pain intensity from preoperative assessment (one week before surgery on average) at 180 days after surgery assessment(One week before surgery on average and 180 days after surgery)
  • Dehiscence at 90 days after surgery assessment(90 days after surgery)
  • Seroma at 60 days after surgery assessment(60 days after surgery)
  • Seroma at 90 days after surgery assessment(90 days after surgery)
  • Change in self reported pain intensity from preoperative assessment (one week before surgery on average) at 30 days after surgery assessment(One week before surgery on average and 30 days after surgery)
  • Dehiscence at 60 days after surgery assessment(60 days after surgery)
  • Change in self reported pain intensity from preoperative assessment (one week before surgery on average) at 90 days after surgery assessment(One week before surgery on average and 90 days after surgery)
  • Seroma at 15 days after surgery assessment(15 days after surgery)
  • Change in self reported pain intensity from preoperative assessment (one week before surgery on average) at 07 days after surgery assessment(One week before surgery on average and 07 days after surgery)
  • Change in self reported pain intensity from preoperative assessment (one week before surgery on average) at 60 days after surgery assessment(One week before surgery on average and 60 days after surgery)
  • Seroma at 07 days after surgery assessment(07 days after surgery)
  • Change in upper limbs function from preoperative assessment (one week before surgery on average) at 30 days after surgery assessment(One week before surgery on average and 30 days after surgery)
  • Change in upper limbs function from preoperative assessment (one week before surgery on average) at 90 days after surgery assessment(One week before surgery on average and 90 days after surgery)
  • Dehiscence at 07 days after surgery assessment(07 days after surgery)
  • Dehiscence at 15 days after surgery assessment(15 days after surgery)
  • Dehiscence at 30 days after surgery assessment(30 days after surgery)
  • Seroma at 30 days after surgery assessment(30 days after surgery)

研究者

发起方
Federal University of São Paulo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gil Facina

FUSaoPaulo PT3

Federal University of São Paulo

研究点 (2)

Loading locations...

相似试验