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Breast Cancer Rehabilitation With Acupuncture and Physical Therapy Protocol

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ClinicalTrials.gov Identifier: NCT02798263
Recruitment Status : Recruiting
First Posted : June 14, 2016
Last Update Posted : August 7, 2019
Sponsor:
Information provided by (Responsible Party):
Gil Facina, Federal University of São Paulo

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.


Condition or disease Intervention/treatment Phase
Pain Other: Kinesiotherapy Other: Acupuncture Other: Stiper Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trials of Acupuncture Effectiveness in the Rehabilitation of Women Under the Physical and Functional Dysfunction to Surgical Treatment of Breast Cancer
Actual Study Start Date : May 2016
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
Other: 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.

Experimental: : Group II Acupuncture
Treated with 30 minutes of classical acupuncture using predefined points
Other: Acupuncture
30 minutes of classical acupuncture using predefined points.

Experimental: Group III Stiper
They will be used the same acupuncture points of the group II, but using the needles in place Stiper®
Other: Stiper
They will be used the same acupuncture points of the group II, but using the needles in place Stiper.




Primary Outcome Measures :
  1. Presence of pain [ Time Frame: four years ]
    Presence of pain by Visual Analog Scale of Pain (VAS).


Secondary Outcome Measures :
  1. shoulder range of motion [ Time Frame: four years ]
    Shoulder range of motion by active goniometry of flexion movements, extension, adduction, abduction, internal rotation and external rotation in degrees

  2. lymphedema presence [ Time Frame: four years ]
    lymphedema presence through top member perimetry(centimeters).

  3. upper limb function [ Time Frame: four years ]
    upper limb function through the DASH questionnaire.

  4. depressive symptoms [ Time Frame: four years ]
    Depressive symptoms through BECK questionnaire.

  5. quality of life of patients after breast cancer surgery [ Time Frame: four years ]
    Quality of life through the EORTC questionnaire.

  6. muscle strength [ Time Frame: four years ]
    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(Kg).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02798263


Locations
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Brazil
University Federal of Sao Paulo Recruiting
Sao Paulo, Brazil, SP
Contact: Gil Facina, PhD    55 11 55793321    gilfacina@hotmail.com   
Contact: Patricia Santolia, MD    55 11 55793321    patysantolia@hotmail.com   
Sponsors and Collaborators
Federal University of São Paulo

Layout table for additonal information
Responsible Party: Gil Facina, Doctor, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT02798263     History of Changes
Other Study ID Numbers: FUSaoPaulo PT 4
First Posted: June 14, 2016    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No