GRASP: Getting it Right: Addressing Shoulder Pain. Clinical and cost effectiveness of progressive exercise compared to best practice advice, with or without corticosteroid injection, for the treatment of rotator cuff disorders: a 2x2 factorial randomised controlled trial

INTERVENTION: Trade Name: Depo‐Medrone Product Name: Methylprednisolone acetate Pharmaceutical Form: Injection INN or Proposed INN: Methylprednisolone Acetate CAS Number: 83‐43‐2 Concentration unit: mg milligram(s) Concentration type: up to Concentration number: 40‐ Trade Name: Kenalog Product Name: Triamcinolone acetonide Pharmaceutical Form: Solution for injection INN or Proposed INN: Triamcinolone acetonide CAS Number: 76‐25‐5 Concentration unit: mg milligram(s) Concentration type: up to Concentration number: 80‐ CONDITION: Rotator Cuff Partial Tear (not full tear) ; MedDRA version: 19.0 Level: LLT Classification code 10039226 Term: Rotator cuff injury System Organ Class: 100000004859 Therapeutic area: Diseases [C] ‐ Musculoskeletal Diseases [C05] PRIMARY OUTCOME: Main Objective: The primary research objective is to assess whether:; ; An individually tailored progressive exercise programme, that includes behavioural change strategies, led by a physiotherapist provides greater improvement in shoulder pain and function at 12 months post‐randomisation than a best practice advice session with a physiotherapist supported by high quality materials; and whether an injection into the shoulder (a subacromial corticosteroid injection) provides greater improvement in shoulder pain and function at 12 months post‐randomisation than no injection.; ; This will be assessed by the the pain and function levels of each participant at 12 months after entering the trial. Primary end point(s): The primary outcome is shoulder pain and function at 12 months measured using the well‐validated Shoulder Pain and Disability Index (SPADI), which was developed to measure current shoulder pain and disability in an outpatient setting. Secondary Objective: Do participants in the different treatment groups have differences in:; Pain, Function, Quality of Life, Sleep disturbance, Medication usage, usage of the NHS, Time off work, their undertaking of the treatment and their feelings towards their treatment at 8 weeks, 6 and 12 months after entering the trial. ; Timepoint(s) of evaluation of this end point: 12 months after randomisation SECONDARY OUTCOME: Secondary end point(s): Do participants in the different treatment groups have differences in:; Pain, Function, Quality of Life, Sleep disturbance, Medication usage, usage of the NHS, Time off work, their undertaking of the treatment and their feelings towards their treatment at 8 weeks, 6 and 12 months after entering the trial. ; Timepoint(s) of evaluation of this end point: 8 weeks, 6 months and 12 months INCLUSION CRITERIA: 1) Men and women aged 18 years and above; 2) with a new episode of shoulder pain (i.e., within the last 6 months) attributable to a rotator cuff disorder (e.g., cuff tendonitis, impingement syndrome, tendinopathy or rotator cuff tear) using the diagnostic criteria set out in the BESS (British Shoulder and Elbow Society) guidelines; 3) who are not currently receiving physiotherapy; 4) who are not being considered for surgery; and 5) able to understand spoken and written English. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 600 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 104