Development and implementation of the physiotherapy-led exercise interventions for the treatment of rotator cuff disorders for the ‘Getting it Right: Addressing Shoulder Pain’ (GRASP) trial

Abstract

Objectives The Getting it Right: Addressing Shoulder Pain (GRASP) trial is a large-scale, multicentre, 2 × 2 factorial randomised controlled trial investigating clinical and cost-effectiveness of a progressive exercise programme versus best-practice advice, with or without corticosteroid injection, for treating people with rotator cuff disorders. Here we describe the development, implementation and details of the physiotherapy-led interventions. Methods Medical Research Council guidance for developing complex interventions were used, taking into account clinical guidelines, expert and patient opinion, research evidence, current practice variation, and deliverability. A stakeholder meeting of 26 experts, clinicians, researchers, and patient representatives was used to design key components of the interventions. Stakeholders prioritised strengthening posterior rotator cuff muscles and using practical, easy-to-do exercises. The interventions were designed to be deliverable across the UK National Health Service. Results Progressive exercise consists of up to six sessions with a physiotherapist over 16 weeks. The best-practice advice consists of one face-toface session with a physiotherapist with substantially greater reliance on self-management. Both interventions include self-management advice, home-exercise instruction, and behaviour-change strategies to target exercise adherence. All participants receive a Participant Information Booklet. The best-practice advice intervention is a self-guided system of progressively challenging exercises, with demonstration videos and written materials. The progressive exercise intervention has a wider range of exercise options, and greater flexibility for tailoring, progression, supervised practice and feedback. Conclusion GRASP has recruited 708 participants and will provide high quality evidence to inform management of people with shoulder pain due to a rotator cuff disorder. Results are anticipated in 2020.

Progressive exercise compared with best practice advice, with or without corticosteroid injection, for the treatment of patients with rotator cuff disorders (GRASP): a multicentre, pragmatic, 2 × 2 factorial, randomised controlled trial

“…We found no difference in prespecified subgroup analyses over 12 months for the primary outcome, with the exception of corticosteroid injection, in which the effect was stronger at 8 weeks in participants with a higher baseline SPADI score (adjusted MD -9•67 [99% CI -15•37 to -3•97]), compared with those who received the injection but had a lower baseline SPADI score (-0•36 [-6•87 to 6•16]; appendix pp [13][14][15][16][17][18]. No serious adverse events were reported.…”

“…The exercises were designed using similar concepts to the progressive exercise intervention, such as increased resistance and done five times per week, but these were a simpler range of exercise options that were not supervised. 13 Physiotherapists delivering progressive exercise and best practice advice were trained separately by a GRASP trial research physiotherapist and had access to a comprehensive intervention manual. A rigorous quality control programme was done to ensure intervention fidelity.…”

“…Because of existing evidence of the greater effectiveness of corticosteroid injection compared with placebo for short-term management, we excluded the use of placebo injection from our protocol. Full details of the exercise interventions have been reported previously 13 and here described in brief.…”

“…Thereafter, patients received up to five sessions, each 20–30 min, for the physiotherapist to progress or regress the exercise prescription using a standardised protocol. 13 Exercises focused on movements commonly affected by a rotator cuff disorder: resisted external rotation, flexion, and abduction of the shoulder. Participants were given a folder containing an advice booklet, exercise action planner, diary, and instructions on their exercise programme set up in collaboration with the physiotherapist.…”

Posterior shoulder tightness; an intersession reliability study of 3 clinical tests

“…Posterior shoulder tightness (PST) has been proposed as an important physical impairment in the management of the athletic shoulder [5][6][7] and increasingly in the nonsporting shoulder [8,9]. Many authors recommend treatment of the posterior shoulder as part of the treatment algorithm for the management of shoulder pain [10,11], and many RCT's investigating the impact of exercise on shoulder pain have included a 'posterior shoulder' intervention as part of their exercise program [12][13][14].…”