Breast Cancer Rehabilitation With Acupuncture and Physical Therapy Protocol

NCT ID: NCT02798263

Last Updated: 2022-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2021-06-30

Brief Summary

The pain is very common complaint, and the neck is one of the most affected spots, mainly due to muscle contracture of the cervical and scapular region, triggered by emotional stress associated with muscle retraction involved resulting from postoperative scarring or post-radiotherapy.O fear fibrosis move the limb and inactivity postoperative lead to gradual impairment of muscle strength and flexibility, and loss of ADM, which also predisposes to the appearance of pain.

Goals Study the effectiveness of acupuncture in rehabilitation of physical and functional disorders of women undergoing surgery for breast cancer.

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.

Patients will be divided into three randomized groups with 30 patients per group, who will receive weekly treatment for 10 weeks, and the group I treated with standard therapeutic exercise, pre-defined, based on stretching the neck muscles, shoulder girdle and exercises for ADM upper limb lasting 30 minutes; group II is treated com30 minutes classical acupuncture using pre-defined spots, and finally, grupoIII be used in the same acupuncture points of the group II, but using the Stiper® in place of the needles. If the patients in groups II and III still of pain at the end of 10 sessions will be treated complementarily with kinesiotherapy.

Detailed Description

Objectives General Study the effectiveness of acupuncture in rehabilitation of physical and functional disorders of women undergoing surgery for breast cancer.

Specific

To evaluate the (the):

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.

rationale The increased incidence of breast cancer and successful treatment result in greater survival. These patients may have chronic condition of pain in the area of the shoulder girdle and upper limb, including the thoracic and cervical spine. Knowing that in our previous project in which the group treated only with kinesiotherapy showed good results and when joined acupuncture no superiority, the investigators created new research study in order to determine whether acupuncture and Stiper® in isolated groups, would present equivalence results when compared to kinesiotherapy.The investigators propose then treat with acupuncture and analyze the rehabilitation of these patients.

methodology This study will be performed at the Clinic of the Department of Mastology the Department of Gynecology, Federal University of São Paulo (UNIFESP) - Paulista School of Medicine (EPM). Patients will be recruited, selected and informed about the study objectives, relevance, activities to be developed and the possibility of improvement, as well as answer your questions and concerns about the disease. Later the patients who wish to participate in the study protocol will sign a consent form and specific savy for this project.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group I kinesiotherapy

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

Group Type: EXPERIMENTAL

Kinesiotherapy

Intervention Type: OTHER

Compare the standard treatment of pain, by kinesiotherapy versus acupuncture and Stiper.Standard therapeutic exercise, pre-defined, based on stretching the neck muscles, shoulder girdle and upper limb exercises for ADM lasting 30 minutes.

: Group II Acupuncture

Treated with 30 minutes of classical acupuncture using predefined points

Group Type: EXPERIMENTAL

Acupuncture

Intervention Type: OTHER

30 minutes of classical acupuncture using predefined points.

Group III Stiper

They will be used the same acupuncture points of the group II, but using the needles in place Stiper®

Group Type: EXPERIMENTAL

Stiper

Intervention Type: OTHER

They will be used the same acupuncture points of the group II, but using the needles in place Stiper.

Interventions

Kinesiotherapy

Compare the standard treatment of pain, by kinesiotherapy versus acupuncture and Stiper.Standard therapeutic exercise, pre-defined, based on stretching the neck muscles, shoulder girdle and upper limb exercises for ADM lasting 30 minutes.

Intervention Type: OTHER

Acupuncture

30 minutes of classical acupuncture using predefined points.

Intervention Type: OTHER

Stiper

They will be used the same acupuncture points of the group II, but using the needles in place Stiper.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Underwent surgical treatment of breast cancer, radical or conservative, and exhibiting pain in the region of the shoulder girdle and upper limb, including thoracic and cervical spine after three months of surgery
• Patients should be older than 18 years
• Level of pain ≥ 3 on the Visual Analogue Scale (VAS)

Exclusion Criteria

• Bilateral breast surgery
• Metastatic disease
• Vascular disorders and tactile sensitivity, with diabetes mellitus type I and II and decompensated with lower education level than four years

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Federal University of São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Gil Facina

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Federal of Sao Paulo

São Paulo, , Brazil

Countries

Brazil

Other Identifiers

FUSaoPaulo PT 4

Identifier Type: -

Identifier Source: org_study_id