Accessory Joint and Neural Mobilizations in Shoulder After Breast Cancer Surgery. Randomized Clinical Trial.
1 other identifier
interventional
18
0 countries
N/A
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable breast-cancer
Started Sep 2013
Shorter than P25 for not_applicable breast-cancer
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
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 17, 2015
CompletedFirst Posted
Study publicly available on registry
February 19, 2015
CompletedSeptember 16, 2015
September 1, 2015
9 months
January 17, 2015
September 15, 2015
Conditions
Keywords
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
EXPERIMENTALHumeral head slides, anterior, posterior and caudal slides.
Nerve mobilization
EXPERIMENTALneural tissue longitudinal slide using the median neurodynamic test 1 (Butler).
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.
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
Eligibility Criteria
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
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MARÍA TORRES-LACOMBA, DOCTOR
SUPERVISOR
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