Acupuncture and Breast Cancer Rehabilitation

NCT02691208 | Completed

• 1 other identifier: FUSaoPaulo PT 2
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

acupuncture; breast cancer; rehabilitation; pain

Outcome Measures

Primary Outcomes (1)

• 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

  1. Presence of pain by Visual Analog Scale of Pain (VAS). 2. Shoulder Range of Motion (ROM) by active goniometry of flexion movements, extension, adduction, abduction, internal rotation and external rotation 3. lymphedema presence through top member perimetry. 4. upper limb function through the DASH questionnaire. 5. Depressive symptoms through BECK questionnaire. 6. Quality of life through the EORTC questionnaire. 7. Muscle strength of flexion, extension, adduction, abduction, internal rotation and shoulder external rotation with the Hand Held Dynamometer 01,163 model of Lafayette Instrument Company.

  two years

Study Arms (2)

Group I Kinesiotherapy

EXPERIMENTAL

women with pain treated with a predefinided exercises protocol of 30 minutes.

Other: Kinesiotherapy

Group II Acupuncture

EXPERIMENTAL

women with pain treated with a predefinided exercises protocol of 30 minutes followed by 30 minutes of acupuncture, used in predefined points

Other: Acupuncture

Interventions

Kinesiotherapy OTHER

Standard therapeutic exercise, pre-defined, based on stretching the neck muscles, shoulder girdle and upper limb exercises for ADM lasting 30 minutes.

Group I Kinesiotherapy

Acupuncture OTHER

Standard therapeutic exercise, pre-defined, based on stretching the neck muscles, shoulder girdle and upper limb exercises for ADM lasting 30 minutes plus 30 minutes of classical acupuncture using predefined points.

Group II Acupuncture

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Federal University of São Paulo

São Paulo, São Paulo, 04024002, Brazil

Location

MeSH Terms

Conditions

Pain; Breast Neoplasms

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Gil Facina, PhD

  BRazil:Research committee - Recruting

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: February 11, 2016
• First Posted: February 25, 2016
• Study Start: August 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: June 6, 2016

Record last verified: 2016-06

Locations

BR (1)