1. There were no significant differences in shoulder pain and disability indices between progressive exercise vs. best practice physiotherapy and corticosteroid injection vs. no injection.
2. Best practice advice (single physiotherapy session) plus corticosteroid injection was found to be the most cost-effective intervention at approximately £479 per quality-adjusted life years gained.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Rotator cuff injuries are commonly managed through a combination of pharmacologic and non-pharmacologic therapies. While physiotherapist-prescribed exercise is helpful, corticosteroid injections are also useful for managing inflammation and pain relief. However, there exists little evidence around the effectiveness of said treatments. Additionally, physiotherapy can be time-consuming, and it is uncertain whether having additional expert-guided sessions has a favorable cost-benefit relationship. This randomized controlled trial aimed to compare the clinical effectiveness and cost-effectiveness of individual-based exercise programme with a single physiotherapy session, with or without corticosteroid injection, in patients with rotator cuff injury. The primary outcome was the Shoulder Pain and Disability Index (SPADI) score at 12 months, measured on a scale of 0-10, while key secondary outcomes included pain and function sub scores, serious adverse events, and work absence. According to study results, scores for progressive exercise and best practice advice were similar over 12 months, as were scores for corticosteroid injection and no injection. This is the largest study, to date, to assess the effect of exercise interventions in patients with new-onset shoulder injury.
In-depth [randomized controlled trial]: Between March 10, 2017, and May 2, 2019, 2287 patients were screened for eligibility from 20 National Health Service trusts in the UK. Included patients were ≥18 years of age with recent onset rotator cuff injury. Those with a history of shoulder trauma, neurological disease affecting the shoulder, and corticosteroid injection or physiotherapy within past 6 months were excluded. Altogether, 708 patients were enrolled and randomly assigned to one of four groups (n=174 to progressive exercise, n=174 to best practice advice, n=182 to corticosteroid injection plus progressive exercise, and n=178 to corticosteroid injection plus best practice advice). Briefly, those assigned to progressive exercise received up to six sessions with a physiotherapist where exercises and progression schemes were individualized to the patient. Conversely, those assigned to best practice advice received one session with a physiotherapist and progression through exercises was self-guided by the patient’s capability.
The mean age of patients was 55.5 years (standard deviation [SD] 13.1) and majority of them (51%) were male. On average, patients experienced symptoms for 4 months (interquartile range [IQR] 3-6) and had a SPADI score of 54.1 (SD 18.5) at baseline. After 12 months, patients in all four groups showed improvements in their SPADI score from baseline. However, throughout 12 months, there were no significant differences in SPADI scores between progressive exercise and best practice advice (adjusted mean difference -0.66, 99% confidence interval [CI] -4.52 to 3.20) as well as between corticosteroid injection and no injection (adjusted mean difference -1.11, 99% CI -4.47 to 2.26). This was also the case for most secondary outcomes. There were slight differences in patient-reported global impression of treatment for progressive exercise over 6 and 12 months, and improvement in shoulder pain and function at 8 weeks with corticosteroid injection. Cost-benefit analyses looking at the cost per quality-adjusted life-years (QALYs) gained found that best practice advice with corticosteroid injection was the most cost-effective intervention at £479 per QALY gained.
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