The aim of this study is to investigate pre-, intra- and post-operative factors that influence post-operative outcome (shoulder pain, shoulder function and quality of life) after shoulder arthroplasty.
The aim of this study is to investigate pre-, intra- and post-operative factors that influence post-operative outcome (shoulder pain, shoulder function and quality of life) after shoulder arthroplasty. Therefore, factors such as patient characteristics, indication for procedure, pre-operative shoulder pain, pre-operative shoulder function, patient expectations, psychosocial factors, lifestyle factors, length of immobilization and soft tissue integrity, are subject to study. Secondary aims are to investigate: 1. the influences of early mobilization vs. delayed mobilization of the shoulder after shoulder arthroplasty on post-operative shoulder pain, shoulder function and quality of life. 2. the inter- and intrarater reliability of the test battery used in this project, in the shoulder arthroplasty population. 3. the inter- and intrarater reliability of the shoulder joint position sense (SJPS) test and the shoulder joint force sensation (SFS) test. 4. the routines of the orthopedic shoulder surgeons before, during and after performing a shoulder arthroplasty. 5. the routines of physiotherapists in the post-operative rehabilitation of patients with shoulder arthroplasty. 6. the associations between the Patient Reported Outcome Measures (PROMS) used in AZ Monica and the Constant Murley Score (CS), and the PROMS and the Visual Analogue Scale (VAS). and to conduct a questionnaire - and assess its reliability - measuring the expectations of the shoulder arthroplasty patients. In order to reach the aims of this project, a prospective longitudinal study with randomized group allocation will be carried out over 48 months with estimated starting point in January 2020 and finishing in January 2024.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
97
Patients will wear an adduction sling to immobilize the shoulder during the first 4 weeks post-operative
Patients will wear an abduction sling to immobilize the shoulder during the first 4 weeks post-operative, followed by an adduction sling for 2 weeks.
AZ Monica
Deurne, Antwerp, Belgium
RECRUITINGChange in Shoulder Pain and Disability Index (SPADI)
There are 13 items, divided in two subscales: pain (5 items) and function (8 items). Each item is scored from 0 (no pain/no difficulty) to 10 (worst imaginable pain/so difficult it requires help) on a NPRS. The final score is a percentage derived from an average of the two subscales, where higher score means worse outcome.
Time frame: Measured pre-operatively, 6 weeks post-operative, 12 weeks post-operative, 6 months postoperative, 12 months post-operative and 24 months post-operative
Shoulder pain
It is measured with the Visual Analogue Scale (VAS)
Time frame: Measured pre-operatively, 6 weeks post-operative, 12 weeks post-operative, 6 months postoperative, 12 months post-operative and 24 months post-operative
Shoulder function
It is measured with the Constant and Murley Score (CS)
Time frame: Measured pre-operatively, 6 weeks post-operative, 12 weeks post-operative, 6 months postoperative, 12 months post-operative and 24 months post-operative
Active ROM in shoulder abduction, anteflexion, internal rotation and external rotation
It is measured with a Gravity-V inclinometer. The unit of measures is degrees.
Time frame: Measured pre-operatively, 6 weeks post-operative, 12 weeks post-operative, 6 months postoperative, 12 months post-operative and 24 months post-operative
Shoulder muscle strength in anteflexion, internal rotation, external rotation and the lift-off movement
It is measured with a Handheld dynamometer. The unit of the measure is Newton.
Time frame: Measured pre-operatively, 6 weeks post-operative, 12 weeks post-operative, 6 months postoperative, 12 months post-operative and 24 months post-operative
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Proprioception (joint position sense)
Inclinometer and laser pointer are used to measure joint position sense in degrees.
Time frame: Measured pre-operatively, 12 weeks post-operative, 6 months postoperative, 12 months post-operative and 24 months post-operative
Proprioception (muscle force sensation)
A handheld dynamometer is used to measure muscle force sensation in Newton.
Time frame: Measured pre-operatively, 12 weeks post-operative, 6 months postoperative, 12 months post-operative and 24 months post-operative
Patient related outcome measures (PROMS, EQ-D)
Questionnaire Lynxcare (Euro Quality of Life, 5 dimensions (EQ-5D)
Time frame: Measured pre-operatively, 6 weeks post-operative, 12 weeks post-operative, 6 months postoperative, 12 months post-operative and 24 months post-operative
Patient related outcome measures (PROMS, SST)
Questionnaire Lynxcare (Simple Shoulder Test (SST))
Time frame: Measured pre-operatively, 6 weeks post-operative, 12 weeks post-operative, 6 months postoperative, 12 months post-operative and 24 months post-operative
Patient related outcome measures (PROMS, NRS)
Questionnaire Lynxcare (Numeric Rating Scale (NRS))
Time frame: Measured pre-operatively, 6 weeks post-operative, 12 weeks post-operative, 6 months postoperative, 12 months post-operative and 24 months post-operative
Patient related outcome measures (PROMS, DASH)
Questionnaire Lynxcare (Disabilities of the Arm, Shoulder and Hand (DASH))
Time frame: Measured pre-operatively, 6 weeks post-operative, 12 weeks post-operative, 6 months postoperative, 12 months post-operative and 24 months post-operative
Quality of Life (SF-36)
It is a questionnaire to measure patient health, comprising mental health as well as physical health.
Time frame: Measured pre-operatively, 6 weeks post-operative, 12 weeks post-operative, 6 months postoperative, 12 months post-operative and 24 months post-operative