Clinical trial NCT02691208: Acupuncture and Breast Cancer Rehabilitation
Official title: Effectiveness of Acupuncture in Rehabilitation of Physical and Functional Disorders of Women Undergoing Breast câncer Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: acupuncture
breast cancer
rehabilitation
pain
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2016-02-25
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The patients were divided into two randomized groups with 24 patients per group, which were given weekly treatment for 10 weeks, one group treated with Kinesiotherapy lasting 30 minutes and the other group followed Kinesiotherapy the same protocol for another 30 minutes acupuncture using predefined points.

The patients were assessed at baseline, after five weeks and at the end of 10 weeks. Responded to an evaluation form about their registration and social data. The physical examination included the assessment of shoulder range of motion, shoulder muscle strength, circumference of the upper limbs and the presence of pain. Questionnaires of quality of life, upper limb function and depression.

Detailed description: They were included in this study patients undergoing surgical treatment for breast cancer, radical or conservative, and to produce pain in the region of the shoulder girdle and upper limb, including thoracic and cervical spine after three months of surgery. Patients over the age of 18 years and level of pain ≥ 3 on the Visual Analogue Scale (VAS). patients with bilateral breast surgery were excluded, metastatic disease, vascular disorders and tactile sensitivity, with diabetes mellitus type I and II uncompensated and with lower level of education than four years. The patients were divided into two randomized groups with 24 patients per group, which were given weekly treatment for 10 weeks, one group treated with Kinesiotherapy lasting 30 minutes and the other group followed Kinesiotherapy the same protocol for another 30 minutes acupuncture using predefined points.

The patients were assessed at baseline, after five weeks and at the end of 10 weeks. Responded to an evaluation form about their registration and social data. The physical examination included the assessment of shoulder range of motion, shoulder muscle strength, circumference of the upper limbs and the presence of pain. questionnaires application EORC QLQ C30 BECK and DASH.

Eligibility criteria: Inclusion Criteria:

* underwent surgical treatment of breast cancer, radical or conservative,
* pain in scapular girdle, in the thoracic or cervical spine, after three months surgery.
* level of pain ≥ 3 in the Visual Analogue Scale

Exclusion Criteria:

* bilateral breast surgery,
* metastatic disease,
* vascular and tactile sensitivity disorders,
* uncompensated diabetes mellitus type I and II
* lower education level than four years.

Primary outcomes:
measure: Result of rehabilitation about pain, Shoulder Range of Motion, lymphedema presence, upper limb function, Depressive symptoms, Quality of life and Muscle strength with kinesioterapy and acupuncture
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Federal University of São Paulo
Study officials:
affiliation: BRazil:Research committee - Recruting
name: Gil Facina, PhD
role: PRINCIPAL_INVESTIGATOR
References: