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

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Accessory joint mobilization; Other: Nerve mobilization

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Accessory joint mobilization; Humeral head slides, anterior, posterior and caudal slides.	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.
Experimental: Nerve mobilization; neural tissue longitudinal slide using the median neurodynamic test 1 (Butler).	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of Alcala
• Investigators: Study Director: MARÍA TORRES-LACOMBA, DOCTOR, Supervisor

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: January 17, 2015
• First Submitted That Met QC Criteria: February 11, 2015
• First Posted (Estimate): February 19, 2015

Study Record Updates

• Last Update Posted (Estimate): September 16, 2015
• Last Update Submitted That Met QC Criteria: September 15, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: accessory mobilization, nerve mobilization.
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: UAlcala