Profiling Patients With Rotator Cuff Related Shoulder Pain: What Factors Influence Outcomes With Non-operative Care in a Secondary Care Specialist Shoulder Clinic?

Aims and Objectives The overall aim of the study is to examine the factors associated with the outcome of non-surgical care among a cohort of people referred to a specialist shoulder clinic.

The objectives of the study are as follows:

1. To conduct a prospective cohort study of adults with RCRSP presenting to a secondary care clinic in the mid-west suitable for non-operative management.
2. To determine the association between key patient characteristics (demographics, level of disability, comorbidities, etc) and outcome following physiotherapy management of RCRSP.

Introduction Shoulder pain is the third most common musculoskeletal symptom reported in primary care and has a prevalence of up to 26% in the general population. It is a disabling condition, and when symptoms persist, it can impair quality of life, increase psychological distress and reduce the ability to maintain employment. Disorders of the rotator cuff muscle and tendons are the most commonly diagnosed cause of shoulder pain. A strong body of research evidence currently exists recommending non-surgical management (e.g. exercise) as the preferred first-line treatment for rotator cuff disorders. Shoulder surgery is more than twice as expensive as conservative approaches, and more importantly, has not been shown to produce superior outcomes in terms of pain and function compared to no treatment or non-surgical management. Despite this, surgery rates continue to rise.

Non-operative management includes the use of analgesia, physiotherapist led exercise and advice, and judicious use of corticosteroid injections. However, many patients are not receiving guideline based care in the primary care setting and are being unnecessarily referred to secondary care. In addition, due to resource constraints, long waiting times exist within primary care physiotherapy negatively impact patient outcomes and increase overall costs of care. Recent evidence has found that a single advice and education session with a trained physiotherapist followed by a home self-management programme, produced equivalent outcomes to a control intervention of up to six face-to-face physiotherapy session for people with rotator cuff disorders. A recent systematic review by the research team of this model of care has confirmed this finding applies across a range of musculoskeletal disorders. While this research suggests that a 'less is more' approach can be successful in managing musculoskeletal pain, it is likely that some patient cohorts will require more intensive input, as illustrated in studies of low back where those with higher levels of mental health disorders needed more intensive multi-disciplinary input. Therefore, it is important to identify predictors of negative outcomes with non-operative care so that an intervention can be developed which aims to address any modifiable prognostic factors.

A more effective method of education and exercise rehabilitation is required in order to optimise patient outcomes, particularly with primary care facilities at capacity and patients experiencing long wait times for Physiotherapy referral. Carefully designed and implemented education and exercise rehabilitation programmes have the potential to bridge this gap. Research that is collaborative is vital to ensure education and exercise programmes match the needs of patients with RC disorders in the Mid-west.

Exposure Patients recruited for this study will undergo usual physiotherpy care. This typically involves referral to community physiotherapy.

Conservative management strategies will be provided by CORU registered Physiotherapists. Those non-operative strategies included in "usual care" can include one or more of the following; exercise, education, acupuncture, manual therapy, local injection of steroids or anaesthesia, advice, multidisciplinary input.

Comparison This prospective cohort study aims to identify prognostic factors associated with functional recovery among adults with rotator cuff related shoulder pain. The effectiveness of specific interventions will not be investigated.

Those prognostic factors being investigated and OCM's must be collected at baseline on initial presentation and again after a period of time deemed suitable to produce clinically significant changes in collected OCM's - 6 months.

The International Classification of Function, Disability and Health will be used to characterise prognostic factors under the domains of Body Structures and Function, Activity Limitations, Participation Restrictions, as well as Personal and Environmental factors.

Methodology The Clinical Specialist physiotherapist will triage patients presenting with RCRSP and identify those for whom non-surgical care is prescribed. The PhD student will inform patients about the study and invite them to take part. Participants who consent to the study will complete baseline questionnaires. They will be contacted 6 months later to complete a further set of questionnaires.

In the first month, the team will pilot the data collection software (Qualtrics) and study procedures. In a small cohort of 10 patients, the study will examine the feasibility of consenting them to the study in advance of the collection of their baseline characteristic and PROM, and then the actual collection of their baseline characteristic and PROM's. This trial will inform the implementation of the project on a larger scale.

Study Design This prospective cohort study is designed to be pragmatic in nature. The methods described below have been developed based on a review of the international literature (evidence-base), the results of a Systematic Review of the Literature and from the output of meetings with the research team working in the secondary care clinic. This qualitative research will be completed prior to commencing the prospective cohort study. The STROBE standardised reporting guidelines will be followed to ensure the standardised conduct and reporting of research.

Analysis Biostatistical support will be sought from a dedicated biostatistician at the Clinical Research Support Unit in the Health Research Institute at UL. Appropriate descriptive statistics will be used to describe the baseline characteristics of study participants. These will include proportions, percentages, ranges, means and standard deviations and medians and interquartile ranges (where data are not normally distributed).

Multiple logistic regression will be used to examine the influence of a variety of factors in patient outcomes.

Conclusion By collecting data on the patient characteristics and Patient reported outcome measures it can be better understood the types of people presenting to secondary care clinic with RCRSP.

By tracking their outcomes over six months, a better understanding of what patient characteristics and prognostic factors influence outcomes will be developed.

In the future, efforts can be made to target modifiable prognostic factors and modify pathways of care to optimise prognosis.