The COMBINED Study to Integrate Health Behaviour Change for People With a Rotator Cuff Disorder (COMBINED)
Physiotherapy, Rotator Cuff Syndrome, Rotator Cuff Impingement Syndrome
About this trial
This is an interventional health services research trial for Physiotherapy focused on measuring Rotator cuff, Physiotherapy, Shoulder pain, Lifestyle
Eligibility Criteria
Inclusion Criteria: The inclusion criteria for the clinician participants are: A qualified (HCPC registered) physiotherapist involved in the management of patients with a RC disorder at one of the trial sites; Willing to consent to the study procedures, including attending a training workshop, audio-recording of the consultations and audit/feedback on intervention delivery. The inclusion criteria for patient participants are: Adult (aged 18 or over); Diagnosed with a RC disorder as per the diagnostic criteria in the British Elbow and Shoulder Society guidelines (Kulkarni et al., 2015), which includes pain mid-range on abduction movement, pain on resisted tests and no loss of external rotation, along with screening of the neck and ruling out other conditions (e.g., instability/frozen shoulder). This will be confirmed by the site Principal Investigators (PI), specialist HCPC registered physiotherapists; Able to attend at least one face-to-face physiotherapy consultation. Eligibility will be confirmed via physical examination at this session as per the criteria above; Able to give full informed consent; Willing to consent to the study procedures, including audio-recording of the consultations. Exclusion Criteria: The exclusion criteria for the patient participants are: Significant trauma; Neurological or inflammatory causes of their shoulder pain; Any clinical indications of serious pathology. We will not exclude anyone based upon protected characteristics for example, age and ethnicity. Anyone referred into the physiotherapy department with a RC disorder will be eligible to take part in the study. Measures in place may include support for the consent process, consultation or patient interviews where required, for example, if verbal translation is needed via a hospital interpreter, personal interpreter or telephone translation service.
Sites / Locations
Arms of the Study
Arm 1
Experimental
Intervention arm
This is a single arm interventional study. A patient-level intervention, which includes: An assessment of existing lifestyle factors (smoking status, physical activity levels, and weight) that may be relevant to shoulder pain; A brief intervention to support health behaviour change with respect to the target behaviours of smoking cessation, increasing physical activity levels and consuming a healthy diet Supporting tools for behaviour change, including an activity workbook for goal-setting and a diary for self-monitoring (attached). The intervention is to be delivered by physiotherapists, integrated within a routine consultation for people with a RC disorder. A clinician-level implementation toolkit to support the delivery of the clinical intervention, which includes a training package and additional resources e.g. scripts to aid conversations with patients.