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Accessory Joint and Neural Mobilizations in Shoulder After Breast Cancer Surgery. Randomized Clinical Trial.

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Accessory joint mobilization
Nerve mobilization
Sponsored by
University of Alcala
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring accessory mobilization, nerve mobilization.

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • unilateral breast cancer diagnosis
  • breast cancer with axillary lymph node dissection
  • be willing to sign the informed consent form

Exclusion Criteria:

  • bilateral breast cancer diagnosis
  • loco-regional recurrence
  • systemic disease
  • had not undergone the axillary lymph node dissection approach
  • to present any contraindication for Physical Therapy.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Accessory joint mobilization

    Nerve mobilization

    Arm Description

    Humeral head slides, anterior, posterior and caudal slides.

    neural tissue longitudinal slide using the median neurodynamic test 1 (Butler).

    Outcomes

    Primary Outcome Measures

    Shoulder Range of motion
    Shoulder movements measured: flexion, extension, abduction, external e internal rotation. Measure instrument: inclinometer. Unit of measure: degrees. Number of participants: 18.

    Secondary Outcome Measures

    Pain
    Measure instrument: Visual Analogue Scale to measure the grade of pain: scale from 0 (no pain) to 10 (unbearable pain). Patients choose where is located their pain throughout this scale. Unit of measure: from 0 to 10 points. Number of participants: 18.
    Upper limb functionality
    Measured items: daily life activities related to the upper limb such as to comb, to get washed, to button the bra, to mop the floor, to clean windows, to hang up, to make the bed, to carry the shopping cart, to put on the pullover, to take off the pullover, leisure. Measure instrument: the Wingate's Daily Life Activities Table to measure the daily life activities difficulty. Patients give a score of how difficult is each daily life activity. Score from 0 (no difficulty) to 3 (disability). Unit of measure: from 0 to 3 points. Number of participants: 18.

    Full Information

    First Posted
    January 17, 2015
    Last Updated
    September 15, 2015
    Sponsor
    University of Alcala
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02366793
    Brief Title
    Accessory Joint and Neural Mobilizations in Shoulder After Breast Cancer Surgery. Randomized Clinical Trial.
    Official Title
    Accessory Joint and Neural Mobilizations in Shoulder Range of Motion Restriction After Breast Cancer Surgery. A Pilot Randomized Clinical Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2013 (undefined)
    Primary Completion Date
    June 2014 (Actual)
    Study Completion Date
    June 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Alcala

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The potential consequences after breast cancer surgery are joint pain and sensitive disorders, the main sign of which is alterations in shoulder mobility. Global kinesitherapy has been shown to be effective at increasing shoulder range of motion restriction. However, literature does not consider specific manual therapy techniques, which means peripheral nerves and articular capsule have not been taken into account. These two tissues are potentially damaged structures during surgery and they are main responsible for shoulder range of motion restriction The main objective of this study is to pilot the effectiveness of accessory joint and nerve mobilization techniques in order to get an overview of the articular capsule and nerve dysfunctions involvement in shoulder motion restriction.
    Detailed Description
    Background: The potential consequences after breast cancer surgery are joint pain and sensitive disorders, the main sign of which is alterations in shoulder mobility. Design: Prospective randomized and double-blind pilot trial. Objective: To pilot the effectiveness of accessory joint and nerve mobilization techniques in order to get an overview of the joint capsule and nerve involvement in shoulder motion restriction. Participants: 18 women who were undergoing unilateral breast cancer surgery and axillary lymph node dissection. Setting: Women´s Health Research Group at Physical Therapy Department of University of Alcala, Madrid, Spain. Intervention: accessory joint mobilization versus neural mobilization. Follow-up: Six-month follow-up. Key outcomes: Range of motion, sensitive disorder, pain and upper limb functionality.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer
    Keywords
    accessory mobilization, nerve mobilization.

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    18 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Accessory joint mobilization
    Arm Type
    Experimental
    Arm Description
    Humeral head slides, anterior, posterior and caudal slides.
    Arm Title
    Nerve mobilization
    Arm Type
    Experimental
    Arm Description
    neural tissue longitudinal slide using the median neurodynamic test 1 (Butler).
    Intervention Type
    Other
    Intervention Name(s)
    Accessory joint mobilization
    Intervention Description
    Three kinds of humeral head slides: anterior, posterior and caudal slides. Subjects remained in supine position during the whole treatment. The techniques were applied in a rhythmical way, with 2 seconds of slide/traction and then a 2-second break. Each technique was carried out for 2 minutes.
    Intervention Type
    Other
    Intervention Name(s)
    Nerve mobilization
    Intervention Description
    Neural tissue longitudinal slide using the median neurodynamic test 1 (MNT1) that was described by Butler. The proximal parameters (scapular depression, abduction and humeral external rotation) were introduced with maximum neural tension. On the other hand, the distal parameters (supination, elbow extension, wrist and fingers extension) received the remaining tension that the neural tissue allowed. The parameters were introduced sequentially in the order exposed
    Primary Outcome Measure Information:
    Title
    Shoulder Range of motion
    Description
    Shoulder movements measured: flexion, extension, abduction, external e internal rotation. Measure instrument: inclinometer. Unit of measure: degrees. Number of participants: 18.
    Time Frame
    15 min
    Secondary Outcome Measure Information:
    Title
    Pain
    Description
    Measure instrument: Visual Analogue Scale to measure the grade of pain: scale from 0 (no pain) to 10 (unbearable pain). Patients choose where is located their pain throughout this scale. Unit of measure: from 0 to 10 points. Number of participants: 18.
    Time Frame
    5 min
    Title
    Upper limb functionality
    Description
    Measured items: daily life activities related to the upper limb such as to comb, to get washed, to button the bra, to mop the floor, to clean windows, to hang up, to make the bed, to carry the shopping cart, to put on the pullover, to take off the pullover, leisure. Measure instrument: the Wingate's Daily Life Activities Table to measure the daily life activities difficulty. Patients give a score of how difficult is each daily life activity. Score from 0 (no difficulty) to 3 (disability). Unit of measure: from 0 to 3 points. Number of participants: 18.
    Time Frame
    10 min

    10. Eligibility

    Sex
    Female
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: unilateral breast cancer diagnosis breast cancer with axillary lymph node dissection be willing to sign the informed consent form Exclusion Criteria: bilateral breast cancer diagnosis loco-regional recurrence systemic disease had not undergone the axillary lymph node dissection approach to present any contraindication for Physical Therapy.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    MARÍA TORRES-LACOMBA, DOCTOR
    Organizational Affiliation
    SUPERVISOR
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Accessory Joint and Neural Mobilizations in Shoulder After Breast Cancer Surgery. Randomized Clinical Trial.

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