Although physical factors play an important role in the treatment and outcomes after proximal humerus fracture (PHF), psychosocial factors need to be taken into account as well.
Few studies have been done to assess the influence of psychosocial factors and mental distress on the outcomes after shoulder surgery and show that it has a negative correlation on the outcomes. It is reported that having low resilience, negative thoughts, signs of depression or anxiety have a significant negative relation with the patient reported outcomes (PROMs).
Mental vulnerability is linked to neuroticism, a personality factor of the Big Five traits, that can be characterized by the tendency to experience negative affect, especially when threatened, frustrated, or facing loss. Neuroticism is related to worse outcomes of health and disease in patients. Although studies have been done to objectify the correlation between psychological factors and functional outcomes after surgery there has not yet been a trial where an intervention has taken place to improve functional outcomes when patients have neurotic tendencies. With this study, we aim to improve the functional outcomes for patients with neuroticism and proximal humerus fractures undergoing surgery by giving them psychological training in the form of focused cognitive behavioral therapy additionally to the standard care. Psychological treatment has shown to improve the well-being of the 'patient characteristics associated with neuroticism and reduce rumination and worry.
Therefore, we hypothesize that providing psychological guidance, consisting of a focused cognitive behavioral therapy program, to patients with neuroticism after a PHF will lead to better patient related outcomes.
Surgically treated proximal humerus fracture, not older than two weeks
A high or very high level of neuroticism (cut-off score on NEO-FFI test off 37)
Minimal age of 18 years
The fracture must be a mono-injury (not part of a multi-injury incident)
Any diagnosed psychiatric disorder that is not adequately managed with medication.
Not being able to communicate: language barrier, neurologic disorders
Paralysis on the affected arm
Not able to participate in online or real time psychological training
Parallel
Psychological intervention
BehavioralPsychological guidance consists of 8 sessions cognitive behavior therapy and starts three weeks after surgery. Sessions consist of psychoeducation and evidence-based interventions and exercises concerning gradual activation relaxation techniques, pain perception and coping with pain, changing unhelpful beliefs, fear, worry about pain and revalidation. Improving treatment adherence (physiotherapy, medication, psychological treatment) and (perceived) social support. Treatment will be guided by licensed medical psychologists. The first 3 sessions will be at the hospital outpatient clinic of the psychologists and the other 5 sessions will be either via videocall or at the outpatient clinic, by patients' choice. The sessions will last 45-60 minutes. There is no use of comparator or placebo.
Functional outcome score - Constant Shoulder Score
The Constant Shoulder Score (CSS) is a comprehensive questionnaire that evaluates shoulder function across four domains: pain, activities of daily living (ADLs), range of motion (ROM), and strength. Pain and ADLs are self-reported by the patient, while ROM and strength are assessed by an investigator. Strength is measured at a 90-degree lateral abduction angle. The CSS consists of 10 items, with a separate assessment for each arm, providing a detailed measure of shoulder function. Lowest score is 0 and highest score is 100. A higher score indicates a better function.
Functional outcome core - Oxford Shoulder Score
The Oxford Shoulder Score (OSS) is a self-assessment questionnaire consisting of 12 items, designed to evaluate two main domains: pain and daily shoulder function. Four of the questions focus on pain, while the remaining eight assess daily functional limitations. The recall period for this questionnaire is 4 weeks. Scores ranging from 0 to 48, with lower scores indicating better function.
Functional outcome score - quick Disability of the Arm, Shoulder and Hand
The Quick Disability of the Arm, Shoulder, and Hand (qDASH) is a shortened version of the original DASH questionnaire, comprising 11 items in total. It assesses two key domains: symptoms and shoulder function. Of the 11 questions, three pertain to symptoms, and eight focus on functional limitations. The recall period for the qDASH is 1 week. Scale for this scores ranges from 0 to 100. Lower scores indicate better function.
Pain levels using Visual Analogue Scale
The Visual Analogue Scale (VAS) consists of a 10 cm line with two extremes: 'no pain' at one end and 'worst possible pain' at the other. The patient marks their perceived level of pain on the scale, and the pain intensity is quantified by measuring the distance from the 'no pain' endpoint to the marked point.
Complications after surgery
infection, hardware failure, nonunion, malunions, secondary dislocation, AVN, mortality
Click on the lead sponsor to view all of their trials.
Zaandam Medical Center
Lead sponsor
Amsterdam University Medical Center
Collaborator
OLVG
Collaborator
Red Cross Hospital Beverwijk
Collaborator
