Breast Cancer Rehabilitation With Acupuncture and Physical Therapy Protocol

NCT02798263 | Completed DMC

• 1 other identifier: FUSaoPaulo PT 4
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Presence of pain

  Presence of pain by Visual Analog Scale of Pain (VAS).

  four years

Secondary Outcomes (6)

• shoulder range of motion

  four years

• lymphedema presence

  four years

• upper limb function

  four years

• depressive symptoms

  four years

• quality of life of patients after breast cancer surgery

  four years

Study Arms (3)

Group I kinesiotherapy

EXPERIMENTAL

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

Other: Kinesiotherapy

: Group II Acupuncture

EXPERIMENTAL

Treated with 30 minutes of classical acupuncture using predefined points

Other: Acupuncture

Group III Stiper

EXPERIMENTAL

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

Other: Stiper

Interventions

Kinesiotherapy 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 I kinesiotherapy

Acupuncture OTHER

30 minutes of classical acupuncture using predefined points.

: Group II Acupuncture

Stiper OTHER

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

Group III Stiper

Eligibility Criteria

• Age: 18 Years - 80 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, 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

University Federal of Sao Paulo

São Paulo, SP, Brazil

Location

MeSH Terms

Conditions

Pain

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

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: May 16, 2016
• First Posted: June 14, 2016
• Study Start: May 1, 2016
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: January 26, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)