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Multicenter Study
. 2021 Jul 31;398(10298):416-428.
doi: 10.1016/S0140-6736(21)00846-1. Epub 2021 Jul 12.

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

Sally Hopewell  1 , David J Keene  2 , Ioana R Marian  2 , Melina Dritsaki  2 , Peter Heine  2 , Lucy Cureton  2 , Susan J Dutton  2 , Helen Dakin  3 , Andrew Carr  2 , Willie Hamilton  4 , Zara Hansen  2 , Anju Jaggi  5 , Chris Littlewood  6 , Karen L Barker  2 , Alastair Gray  3 , Sarah E Lamb  7 ; GRASP Trial Group
Collaborators, Affiliations
Multicenter Study

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

Sally Hopewell et al. Lancet. .

Abstract

Background: Corticosteroid injections and physiotherapy exercise programmes are commonly used to treat rotator cuff disorders but the treatments' effectiveness is uncertain. We aimed to compare the clinical effectiveness and cost-effectiveness of a progressive exercise programme with a single session of best practice physiotherapy advice, with or without corticosteroid injection, in adults with a rotator cuff disorder.

Methods: In this pragmatic, multicentre, superiority, randomised controlled trial (2 × 2 factorial), we recruited patients from 20 UK National Health Service trusts. We included patients aged 18 years or older with a rotator cuff disorder (new episode within the past 6 months). Patients were excluded if they had a history of significant shoulder trauma (eg, dislocation, fracture, or full-thickness tear requiring surgery), neurological disease affecting the shoulder, other shoulder conditions (eg, inflammatory arthritis, frozen shoulder, or glenohumeral joint instability), received corticosteroid injection or physiotherapy for shoulder pain in the past 6 months, or were being considered for surgery. Patients were randomly assigned (centralised computer-generated system, 1:1:1:1) to progressive exercise (≤6 sessions), best practice advice (one session), corticosteroid injection then progressive exercise, or corticosteroid injection then best practice advice. The primary outcome was the Shoulder Pain and Disability Index (SPADI) score over 12 months, analysed on an intention-to-treat basis (statistical significance set at 1%). The trial was registered with the International Standard Randomised Controlled Trial Register, ISRCTN16539266, and EuDRACT, 2016-002991-28.

Findings: Between March 10, 2017, and May 2, 2019, we screened 2287 patients. 708 patients were randomly assigned to progressive exercise (n=174), best practice advice (n=174), corticosteroid injection then progressive exercise (n=182), or corticosteroid injection then best practice advice (n=178). Over 12 months, SPADI data were available for 166 (95%) patients in the progressive exercise group, 164 (94%) in the best practice advice group, 177 (97%) in the corticosteroid injection then progressive exercise group, and 175 (98%) in the corticosteroid injection then best practice advice group. We found no evidence of a difference in SPADI score between progressive exercise and best practice advice when analysed over 12 months (adjusted mean difference -0·66 [99% CI -4·52 to 3·20]). We also found no evidence of a difference between corticosteroid injection compared with no injection when analysed over 12 months (-1·11 [-4·47 to 2·26]). No serious adverse events were reported.

Interpretation: Progressive exercise was not superior to a best practice advice session with a physiotherapist in improving shoulder pain and function. Subacromial corticosteroid injection provided no long-term benefit in patients with rotator cuff disorders.

Funding: UK National Institute for Health Research Technology Assessment Programme.

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Conflict of interest statement

Declaration of interests SH is a member of the UK National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Clinical Evaluation and Trials Committee (Nov 1, 2018, to Nov 30, 2022). DJK holds an NIHR postdoctoral fellowship. IRM holds an NIHR pre-doctoral fellowship. SJD reports grants from the NIHR HTA programme during the conduct of the study. HD is partly funded by an NIHR senior research fellowship through the Biomedical Research Centre, Oxford, UK. AC is a member of the UK Research and Innovation/Medical Research Council Developmental Pathway Funding Scheme panel. He was chief investigator of the NIHR HTA UK Rotator Cuff Surgery (UKCUFF) trial and the CSAW trial. He is a consultant to the Novartis musculoskeletal board. He is chief investigator of an NIHR i4i trial of a novel electrospun patch and of a Wellcome Trust-funded trial of a novel electrospun suture in rotator cuff repair surgery. He was director of the NIHR Musculoskeletal British Research Unit from 2008 to 2017 and is musculoskeletal theme lead for the NIHR Oxford comprehensive British Research Centre. ZH reports grants from the NIHR HTA programme during the conduct of the study and is paid personal fees by various health-care trusts and individuals to train health-care professionals in cognitive behavioural approaches, outside the submitted work. AJ is a council member of the British Shoulder and Elbow Society. She is co-applicant for the NIHR HTA (Partial Rotator Cuff Tear Repair (PROCURE) trial. CL is chair of the Chartered Society of Physiotherapy scientific panel. He is chief investigator of the NIHR post-doctoral fellowship-funded Surgery versus PhysiothErapist-leD exercise (SPeEDy) study. He was previously lead researcher for the NIHR Research for Patient Benefit funded Rehabilitation Following Rotator Cuff Repair (RaCeR) study and chief investigator for the NIHR doctoral fellowship-funded SELF (a self-managed single exercise programme versus usual physiotherapy treatment for rotator cuff tendinopathy) study. SEL reports grants from the NIHR HTA programme during the conduct of the study and was a member of the following boards: HTA Additional Capacity Funding Board 2012–15; HTA Clinical Trials Board 2010–15; HTA End of Life Care and Add on Studies 2015–15; HTA Funding Boards Policy Group (formerly CSG) 2010–15; HTA Maternal, Neonatal and Child Health Methods Group 2013–15; HTA post-board funding teleconference (Prioritisation Group members to attend) 2010–15; HTA Primary Care Themed Call board 2013–14; HTA Prioritisation Group 2010–15; and NIHR Clinical Trials Unit Standing Advisory Committee 2012–16. All other authors declare no completing interests.

Figures

Figure 1
Figure 1
Trial profile All participants with at least one follow-up timepoint SPADI outcome and the baseline variables used in the model were included in the primary outcome analysis. GRASP=Getting it Right: Addressing Shoulder Pain. SPADI=Shoulder Pain and Disability Index. *Reasons for not receiving best practice advice were participant did not attend session (n=5), withdrawal (n=4), or other medical condition (n=3). †Reasons for not receiving injection only were participant declined treatment (n=2) or contraindicated (n=1 taking anticoagulants and n=1 previous reaction to injection). ‡Reasons for not receiving best practice advice only were participant did not attend session (n=5), other medical condition (n=2), received progressive exercise in error (n=3). §Reasons for not receiving injection and best practice advice were participant did not attend session (n=1), participant declined treatment (n=2), other medical condition (n=2), or previous reaction to injection and received non-GRASP treatment (n=1). ¶Reasons for not receiving progressive exercise were participant did not attend session (n=3), received best practice advice in error (n=2), received injection in error (n=1), received non-GRASP treatment (n=1), or withdrawal (n=1). ||Reasons for not receiving injection only were participant declined treatment (n=5) or clinician declined treatment (n=3). **Reasons for not receiving progressive exercise only were received best practice advice in error (n=2), received non-GRASP treatment (n=3), other medical condition (n=1), or participant did not attend session (n=1). ††Reasons for not receiving injection and progressive exercise were participant did not attend session (n=2) or other medical condition (n=1).
Figure 2
Figure 2
Marginal adjusted mean SPADI scores from baseline to 12 months Results are from the repeated measures mixed-effects model. Figure shows progressive exercise (A) and injection (B). Error bars represent 99% CIs. SPADI=Shoulder Pain and Disability Index.
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