NCT02366793

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Sep 2013

Shorter than P25 for not_applicable breast-cancer

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 19, 2015

Completed
Last Updated

September 16, 2015

Status Verified

September 1, 2015

Enrollment Period

9 months

First QC Date

January 17, 2015

Last Update Submit

September 15, 2015

Conditions

Keywords

accessory mobilization, nerve mobilization.

Outcome Measures

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.

    15 min

Secondary Outcomes (2)

  • Pain

    5 min

  • Upper limb functionality

    10 min

Study Arms (2)

Accessory joint mobilization

EXPERIMENTAL

Humeral head slides, anterior, posterior and caudal slides.

Other: Accessory joint mobilization

Nerve mobilization

EXPERIMENTAL

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

Other: Nerve mobilization

Interventions

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.

Accessory joint 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

Nerve mobilization

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • MARÍA TORRES-LACOMBA, DOCTOR

    SUPERVISOR

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Irene de la Rosa Díaz

Study Record Dates

First Submitted

January 17, 2015

First Posted

February 19, 2015

Study Start

September 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

September 16, 2015

Record last verified: 2015-09