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CompletedNCT02366793Updated Sep 16, 2015

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

An interventional study of Accessory joint mobilization and Nerve mobilization in Breast Cancer, sponsored by University of Alcala. Completed. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-09-16.

Sponsored by University of Alcala · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Randomized
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • Breast Cancer

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Keywords

  • accessory mobilization, nerve mobilization.
03

In context

Breast Neoplasms

12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.

This study's enrollment of 18 is below the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.

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Lead sponsor

University of Alcala is the lead sponsor of 128 studies on the registry; 36 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
18 participants (actual)

Study arms

  • Experimental
    Accessory joint mobilization

    Humeral head slides, anterior, posterior and caudal slides.

    Other: Accessory joint mobilization

  • Experimental
    Nerve mobilization

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

    Other: Nerve mobilization

Interventions

  • OtherAccessory joint mobilization

    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.

  • OtherNerve mobilization

    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

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 15 min

Secondary outcomes

  1. 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.

    Time frame: 5 min

  2. 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.

    Time frame: 10 min

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Study locations

No study locations are listed for this record.

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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2013, a primary completion of Jun 2014 and a completion of Jun 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 17, 2015
First posted
Feb 19, 2015
Start
Sep 2013
Primary completionActual
Jun 2014
CompletionActual
Jun 2014
Last update
Sep 16, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 16, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02366793
Responsible party
IRENE DE LA ROSA DÍAZ (Irene de la Rosa Díaz, University of Alcala) — Principal investigator
First posted
Feb 19, 2015
Start date
Sep 2013
Primary completion
Jun 2014
Completion
Jun 2014
Last update
Sep 16, 2015

Study contacts

MARÍA TORRES-LACOMBA, DOCTOR
study director · SUPERVISOR

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.

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