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Completed

NCT Number: NCT02798263

Breast Cancer Rehabilitation With Acupuncture and Physical Therapy Protocol

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Federal of Sao Paulo

São Paulo, SP, Brazil

About this study

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):

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Acupuncture

Other

30 minutes of classical acupuncture using predefined points.

Stiper

Other

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

Primary outcomes

  1. Presence of pain

    Time frame: four years

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

Secondary outcomes

  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).

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study title

Randomized Clinical Trials of Acupuncture Effectiveness in the Rehabilitation of Women Under the Physical and Functional Dysfunction to Surgical Treatment of Breast Cancer

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Jun 14, 2016
Registry last updated
Jan 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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