NCT03796845

Limited Versus No-limited Shoulder Movement in Breast Cancer Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 465 (actual)
• Sponsor: Instituto Nacional de Cancer, Brazil · Other Government
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

Randomized clinical trial that will include women aged 18 or older, submitted a curative surgery for breast cancer at Hospital do Câncer III (HCIII-INCA). Patients will be allocated into two groups: Intervention (upper limbs no-limited movement with amplitude above 90º for flexion and abduction of shoulder) and Control (upper limbs limited movement at maximum 90º amplitude flexion and abduction of shoulder, until withdrawal surgical points). Sociodemographic and clinical data will be collected through interviews, questionnaires and electronic and physical records. The outcomes will be incidence of operative wound complications, like edema, joint restraint, winged scapula, pain, axillary web syndrome through the physical examination, performed by the nursing and physiotherapy team throughout the intervention period, ending in the 30-day post-operatory.

Detailed description

Breast cancer treatment has been accompanying advances in technology, surgeries are more conservative, however postoperative complications are still observed. At early postoperative period, the most common operative wound complications are seroma, infection and necrosis. Shoulder dysfunctions are a frequent complication and difficult women to return to their activities. There is no consensus regarding the onset and type of exercise in postoperative period. Thus, the objective of this study is to compare the active no-limited mobilization with limited mobilization in the immediate post operatory at the incidence of wound complications in women submitted to surgery for the treatment of breast cancer. It's a randomized clinical trial that will include women aged 18 years or older, submitted a curative surgery for breast cancer at Hospital do Câncer III (HCIII-INCA) located in Rio de Janeiro. All patients admitted for surgical treatment at the institution and during the study period will be evaluated for eligibility criteria. Those considered eligible for the study will be clarified regarding the objectives, treatment groups, adverse effects and non-compulsory participation of the study. Upon acceptance to participate, they will be allocated to the respective intervention groups. Group 1 - upper limbs no-limited movement with amplitude above 90º for flexion and abduction of shoulder; Group 2 - upper limbs limited movement at maximum 90º amplitude flexion and abduction of shoulder, until withdrawal surgical points.

Conditions

• Breast Neoplasms

Interventions

Type	Name	Description
OTHER	No limited movement after surgery	Participants should move their arms from the first postoperative day, with unrestricted movement, with an amplitude above 90º for flexion and abduction of shoulder.

Timeline

• Start date: 2019-02-01
• Primary completion: 2019-07-01
• Completion: 2019-12-20
• First posted: 2019-01-08
• Last updated: 2020-04-07

Locations

1 site across 1 country: Brazil