GRASP - Getting it right: addressing shoulder pain

INTERVENTION: GRASP: Consented participants will be randomised to intervention groups (1:1:1:1) using the centralised computer randomisation service RRAMP (https://rramp.octru.ox.ac.uk) provided by the Oxford Clinical Trials Research Unit (OCTRU). Group 1: Progressive exercise programme: The participants randomised to the progressive exercise programme will receive up to six sessions with a physiotherapist over 16 weeks. This programme consists of 3 phases: Phase 1 – assessment and advice Phase 2 – progressive structured resistance training Phase 3 – patient‐specific functional restoration Group 2: Best practice advice session: The participants randomised to the best practice advice session will receive a single face‐to‐face session with a physiotherapist, lasting up to 60 minutes. After a comprehensive shoulder assessment, the participants will be given education, reassurance and self‐management exercise advice, including advice on pain management and activity modification. They will also be given a simple set of self‐guided exercises that can be progressed and regressed depending on their capability. Group 3: Progressive exercise programme + Methylprednisolone injection or Triamcinolone acetonide injection Participants receive an injection of 40 mg methylprednisolone (Depo‐Medrone) together with local anaesthetic in one injection at the same time, or separately, depending on local treatment protocols at sites OR Participants receive an injection of 20‐40 mg triamcinolone acetonide (Kenalog) together with local anaesthetic in one injection at the same time, or separately, depending on local treatment protocols at sites. (The local anaesthetic will either be 1% lidocaine (up to 5 ml) or 0.5% bupivacaine hydrochloride (up to 10 ml), again depending on local treatment protocols.) This injection will be given once before the progressive exercise intervention is delivered, then the progressive exercise intervention is delivered. The participants randomised to the progressive CONDITION: Rotator cuff problem ; Musculoskeletal Diseases ; Rotator cuff problem PRIMARY OUTCOME: GRASP:; Shoulder pain and function is measured using the Shoulder Pain and Disability Index (SPADI) at baseline, 8 weeks, 6 and 12 months.; ; PROMPTS (embedded retention trial):; Questionnaire response rate, defined as the proportion of GRASP follow up questionnaires returned by participants. SECONDARY OUTCOME: Current secondary outcome measures as of 09/07/2018:; GRASP:; 1. Pain is measured using the Shoulder Pain and Disability Index (SPADI) 5‐item subscale at baseline, 8 weeks, 6 and 12 months; 2. Function is measured using the Shoulder Pain and Disability Index (SPADI) 8‐item subscale at baseline, 8 weeks, 6 and 12 months; 3. Health‐related quality life is measured using the EQ‐5D‐5L at baseline, 8 weeks, 6 and 12 months; 4. Psychological factors are measured using the Fear Avoidance Belief Questionnaire – physical activity 5‐item subscale and Pain Self‐efficacy questionnaire (short form) at baseline, 8 weeks, 6 and 12 months; 5. Sleep disturbance is measured using the Insomnia Severity Index at baseline, 8 weeks, 6 and 12 months; 6. Global impression of treatment is measured using the Patient‐rated Likert scale at 8 weeks, 6 and 12 months; 7. Return to desired activities is measured using the Patient‐reported return to desired activities including work, social life and sport activities at 0, 8 weeks, 6 and 12 months; 8. Exercise adherence is measured using the Patient‐reported adherence to exercise at 8 weeks, 6 and 12 months; 9. Medication usage is measured using the Patient‐reported prescribed and over the counter medications, additional steroid injection at 8 weeks, 6 and 12 months; 10. Work disability is measured by recording the number of days of sick leave taken at 8 weeks, 6 and 12 months; 11. Healthcare use is measured by collecting NHS usage data at 8 weeks, 6 and 12 months; 12. Out‐of‐pocket expenses are measured using patient related recording of out of pocket expenses at 8 weeks, 6 and 12 months; ; PROMPTS (embedded retention trial):; 1. Time to response, defined as the number of days which elapse between the GRASP follow up questionnaire being mailed out to participants and the questionnaire recorded as being returned to the GRASP trial team; 2. The proportion of participants sent a reminder follow up questionnaire; 3. The cost‐effectiveness of the text message intervention; ; Previous secondary outcome measures:; GRASP:; 1. Pain is measured using the Shoulder Pain and Disability Index (SPADI) 5‐item subscale at baseline, 8 weeks, 6 and 12 months; 2. Function is measured using the Shoulder Pain and Disability Index (SPADI) 8‐item subscale at baseline, 8 weeks, 6 and 12 months; 3. Health‐related quality life is measured using the EQ‐5D‐5L at baseline, 8 weeks, 6 and 12 months; 4. Psychological factors are measured using the Fear Avoidance Belief Questionnaire – physical activity 5‐item subscale and Pain Self‐efficacy questionnaire (short form) at baseline, 8 weeks, 6 and 12 months; 5. Sleep disturbance is measured using the Insomnia Severity Index at baseline, 8 weeks, 6 and 12 months; 6. Global impression of treatment is measured using the Patient‐rated Likert scale at 8 weeks, 6 and 12 months; 7. Return to desired activities is measured using the Patient‐reported return to desired activities including work, social life and sport activities at 8 weeks, 6 and 12 months; 8. Exercise adherence is measured using the Patient‐reported adherence to exercise at 8 weeks, 6 and 12 months; 9. Medication usage is measured using the Patient‐reported prescribed and over the counter medications, additional steroid injection at 8 weeks, 6 and 12 months; 10. Work disability is measured by recording the number of days of sick leave taken at 8 weeks, 6 and 12 months; 11. Healthcare use is measured by collecting NHS usage data at 8 weeks, 6 and 12 months; 12. Out‐of‐pocket expenses are measured using patient related recording of out of pocket expenses at 8 weeks, 6 and 12 months; ; PROMPTS (embedded retention trial):; 1. Time to response, defined as the number of days which elapse between the GRASP follow up questionnaire being mailed out to participants and the questionnaire recorded as being returned to the GRASP trial team; 2. The proportion of participants sent a reminder follow up questionnaire; 3. The cost‐effectiveness of the text message intervention INCLUSION CRITERIA: GRASP: 1. Men and women aged 18 years and above 2. 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 guidelines 3. Not currently receiving physiotherapy 4. Not being considered for surgery PROMPTS (embedded retention trial): All participants in the PROMPTS study will have consented and be enrolled in the GRASP trial which will act as the host trial. In addition to meeting the inclusion criteria for the GRASP trial, the following inclusion criteria will apply for participants enrolled in the embedded PROMPTS study: 1. Participants will have the use of a mobile telephone, 2. Participants will be willing to provide this mobile telephone number and consent for contact to be made by the GRASP trial team using this number