Domiciliary Physiotherapy in Women Undergoing Treatment for Breast Cancer Radiation

Shoulder Pain Clinical Trial

Official title:

Domiciliary Physiotherapy in Women Undergoing Treatment for Breast Cancer Radiation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01940107
• Other study ID #: hhacarra
• Status: Completed
• Phase: N/A
• First received: September 6, 2013
• Last updated: September 10, 2013
• Start date: August 2010
• Est. completion date: September 2012

Study information

• Verified date: September 2013
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: CONEP - Comitê Nacional de Ética em Pesquisa
• Study type: Interventional

Clinical Trial Summary

To observe the effect of domiciliary physiotherapy on the upper limb applied during the period of radiotherapy in women submitted to surgical and radiotherapy for breast cancer. The parameters evaluated were: shoulder range of movement (ROM) and arm circumference. There was significant difference between the ipsilateral and contralateral limbs for flexion, abduction and external rotation. There was no difference in perimetry in either group

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• be diagnosed with unilateral breast cancer;

• be submitted to surgical and radiation treatment as part of the treatment for breast cancer.

Exclusion Criteria:

• patients with neurological or orthopedic diseases that could impair the upper limb movements

• bilateral breast cancer;

• prior thoracic radiotherapy;

• presence of distant metastasis.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Frozen Shoulder,
• Shoulder Pain

Intervention

Other:
• evaluations
Only evaluations

Procedure:
• Protocol of physiotherapy exercises
Oriented domiciliary physiotherapeutic exercises

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas de Ribeirão Preto da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo	Ribeirão Preto	Saõ Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recovery of shoulder range of movements (ROM) and prevention of arm lymphedema		90 days	No