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

Breast Cancer Clinical Trial

Official title:

Accessory Joint and Neural Mobilizations in Shoulder Range of Motion Restriction After Breast Cancer Surgery. A Pilot Randomized Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02366793
• Other study ID #: UAlcala
• Status: Completed
• Phase: N/A
• First received: January 17, 2015
• Last updated: September 15, 2015
• Start date: September 2013
• Est. completion date: June 2014

Study information

• Verified date: September 2015
• Source: University of Alcala
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• Accessory 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.
• Nerve 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Alcala

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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.	5 min	Yes
Secondary	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.	10 min	Yes