Dataset Information

Exercise therapy after corticosteroid injection for moderate to severe shoulder pain: large pragmatic randomised trial.

ABSTRACT:

Objective

To compare the effectiveness of subacromial corticosteroid injection combined with timely exercise and manual therapy (injection plus exercise) or exercise and manual therapy alone (exercise only) in patients with subacromial impingement syndrome.

Design

Pragmatic randomised clinical trial.

Setting

Primary care based musculoskeletal service. Patients Adults aged 40 or over with subacromial impingement syndrome with moderate or severe shoulder pain.

Interventions

Injection plus exercise or exercise only.

Main outcome measures

Primary outcome was the difference in improvement in the total shoulder pain and disability index at 12 weeks.

Results

232 participants were randomised (115 to injection plus exercise, 117 to exercise only). The mean age was 56 (range 40-78), 127 were women, and all had had a median of 16 weeks of shoulder pain (interquartile range 12-28). At week 12 there was no significant difference between the groups in change in total pain and disability index (mean difference between change in groups 3.26 (95% confidence interval -0.81 to 7.34), P=0.116). Improvement was significantly greater in the injection plus exercise group at week 1 (6.56, 4.30 to 8.82) and week 6 (7.37, 4.34 to 10.39) for the total pain and disability index (P<0.001), with no differences at week 24 (-2.26, -6.77 to 2.25, P=0.324).

Conclusions

In the treatment of patients with subacromial impingement syndrome, injection plus exercise and exercise only are similarly effective at 12 weeks. Trial registration ISRCT 25817033; EudraCT No 2005-003628-20.

SUBMITTER: Crawshaw DP

PROVIDER: S-EPMC2893301 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:IntroductionShoulder pain is common and the prognosis is often unfavourable. Dutch guidelines on the treatment of shoulder pain in primary care recommend a corticosteroid injection or a referral to exercise therapy, if initial pain management fails and pain persists. However, evidence of the effectiveness of a corticosteroid injection compared with exercise therapy, especially in the long term, is limited. This trial will assess the clinical effectiveness and cost effectiveness of a corticosteroid injection compared with physiotherapist-led exercise therapy over 12 months follow-up in patients with shoulder pain in primary care.Methods and analysisThe SIX Study is a multicentre, pragmatic randomised clinical trial in primary care. A total of 213 patients with shoulder pain, aged ≥18 years presenting in general practice will be included. Patients will be randomised (1:1) into two groups: a corticosteroid injection or 12 sessions of physiotherapist-led exercise therapy. The effect of the allocated treatment will be assessed through questionnaires at 6 weeks and after 3, 6, 9 and 12 months. The primary outcome is patient's reported shoulder pain-intensity and function, measured with the Shoulder Pain and Disability Index, over 12 months follow-up. Secondary outcomes include cost effectiveness, pain-intensity, function, health-related quality of life, sleep quality, patient's global perceived effect, work absence, healthcare utilisation and adverse events. Between group differences will be evaluated using a repeated measurements analysis with linear effects models. A cost-utility analysis will be performed to assess the cost effectiveness using quality-adjusted life years from a medical and societal perspective.Ethics and disseminationThis study was approved by the Medical Ethics Committee of Erasmus MC University Medical Center Rotterdam (MEC 2020-0300). All participants will give written informed consent prior to data collection. The results from this study will be disseminated in international journals and implemented in the primary care guidelines on shoulder pain.Trial registration numberDutch Trial Registry (NL8854).

Project description:BackgroundShoulder pain is a very common presentation in primary care. Evidence of benefit for subacromial corticosteroid injection is inconclusive and confined largely to studies with short follow-up. We plan a large, definitive, primary-care-based trial to determine efficacy and safety in patients with rotator cuff tendinopathy, and conducted a pilot trial to explore feasibility.MethodsSix general practitioners (GPs) from Oxfordshire, UK underwent update training in assessing painful shoulders and injecting the subacromial space. Each then recruited patients aged 35 to 74 years from primary care complaining of shoulder pain lasting no more than 6 months. Eligible participants were randomized to receive either methylprednisolone acetate 40 mg with lidocaine 1% (total volume 1 ml), or lidocaine 1% alone (total volume 1 ml), injected into the subacromial space. The participants were blinded to treatment allocation. Feasibility outcomes were rates of recruitment, withdrawal, adherence to the protocol, completeness of follow-up, and success of patient masking. Clinical outcomes were the Oxford Shoulder Score (OSS) at baseline and at 4 and 12 weeks, and responses to three satisfaction questions at 2, 4 and 12 weeks. Outcome data were collected by postal questionnaires.ResultsA total of 40 participants were randomized (80% of the target 50 participants) over 26 weeks giving an overall recruitment rate of 1.5 participants per week. Rates of follow-up were maintained to a high level for the full 12 weeks. Four participants requested a 'rescue' corticosteroid injection but no patients withdrew. The trial GPs gave high scores for their confidence that the patient had remained blinded to treatment allocation during the procedure. The OSS at 4 and 12 weeks and the responses to the satisfaction questions are reported.ConclusionsIt is feasible to recruit participants with shoulder pain in the primary care setting for a blinded, randomized trial of corticosteroid injection. Online randomization of participants from the practice is also feasible, and postal questionnaires provide an effective means of gathering outcome data in this area of study. The lessons learned from this pilot will usefully inform the design of a large, definitive efficacy trial in primary care.Trial registrationCurrent Clinical Trials ISRCTN82357435.

Project description:ObjectiveTo compare treatment effects between ultrasound guided lavage with corticosteroid injection and sham lavage with and without corticosteroid injection in patients with calcific tendinopathy of the shoulder.DesignPragmatic, three arm, parallel group, double blinded, sham controlled, randomised, superiority trial with repeated measurements over 24 months.SettingSix hospitals in Norway and Sweden.Participants220 adults with calcific tendinopathy of the shoulder, persistent for at least three months.InterventionsUltrasound guided deposit lavage plus subacromial injection of 20 mg triamcinolone acetonide and 9 mL 1% lidocaine hydrochloride (lavage+steroid); sham lavage plus subacromial injection of 20 mg triamcinolone acetonide and 9 mL 1% lidocaine hydrochloride (sham lavage+steroid); or sham lavage plus subacromial injection of 10 mL 1% lidocaine hydrochloride (sham). All patients received a physiotherapeutic treatment regimen consisting of four home exercises.Main outcome measuresThe primary outcome was the result on the 48 point scale (0=worst; 48=best) of the Oxford Shoulder Score (OSS) at four month follow-up. Secondary outcomes included measurements on the short form of the Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH) and of pain intensity up to 24 months. The influence of the size of the deposit at baseline and of the persistence or disappearance of the deposit was investigated.ResultsData from 218 (99%) participants were included in the primary analysis. Differences between groups on the OSS at four months were not significant: lavage+steroid versus sham 0.2 (95% confidence interval -2.3 to 2.8; P=1.0); sham lavage+steroid versus sham 2.0 (-0.5 to 4.6; P=0.35); lavage+steroid versus sham lavage+steroid -1.8 (-4.3 to 0.7; P=0.47). After four months, 143 patients with insufficient treatment effect received supplementary treatment. At 24 months, none of the study procedures was superior to sham. No serious adverse events were reported.ConclusionsThis study found no benefit for ultrasound guided lavage with a corticosteroid injection or for sham lavage with a corticosteroid injection compared with sham treatment in patients with calcific rotator cuff tendinopathy of the shoulder.Trial registrationNCT02419040EudraCT 2015-002343-34; Ethical committee Norway 2015-002343-34; Ethical committee Sweden 2015/79-31; Clinicaltrials.gov NCT02419040.

Project description:BackgroundPatients with difficult-to-control asthma consume 50-60% of healthcare costs attributed to asthma and cost approximately five-times more than patients with mild stable disease. Recent evidence demonstrates that not all patients with asthma have a typical type 2 (T2)-driven eosinophilic inflammation. These asthmatics have been called 'T2-low asthma' and have a minimal response to corticosteroid therapy. Adjustment of corticosteroid treatment using sputum eosinophil counts from induced sputum has demonstrated reduced severe exacerbation rates and optimized corticosteroid dose. However, it has been challenging to move induced sputum into the clinical setting. There is therefore a need to examine novel algorithms to target appropriate levels of corticosteroid treatment in difficult asthma, particularly in T2-low asthmatics. This study examines whether a composite non-invasive biomarker algorithm predicts exacerbation risk in patients with asthma on high-dose inhaled corticosteroids (ICS) (± long-acting beta agonist) treatment, and evaluates the utility of this composite score to facilitate personalized biomarker-specific titration of corticosteroid therapy.Methods/designPatients recruited to this pragmatic, multi-centre, single-blinded randomised controlled trial are randomly allocated into either a biomarker controlled treatment advisory algorithm or usual care group in a ratio of 4:1. The primary outcome measure is the proportion of patients with any reduction in ICS or oral corticosteroid dose from baseline to week 48. Secondary outcomes include the rate of protocol-defined severe exacerbations per patient per year, time to first severe exacerbation from randomisation, dose of inhaled steroid at the end of the study, cumulative dose of inhaled corticosteroid during the study, proportion of patients on oral corticosteroids at the end of the study, proportion of patients who decline to progress to oral corticosteroids despite composite biomarker score of 2, frequency of hospital admission for asthma, change in the 7-item Asthma Control Questionnaire (ACQ-7), Asthma Quality of Life Questionnaire (AQLQ), forced expiratory volume in 1 s (FEV1), exhaled nitric oxide, blood eosinophil count, and periostin levels from baseline to week 48. Blood will also be taken for whole blood gene expression; serum, plasma, and urine will be stored for validation of additional biomarkers.DiscussionMulti-centre trials present numerous logistical issues that have been addressed to ensure minimal bias and robustness of study conduct.Trial registrationClinicalTrials.gov, NCT02717689 . Registered on 16 March 2016.

Project description:BackgroundThe Getting it Right: Addressing Shoulder Pain (GRASP) trial assesses the clinical and cost-effectiveness of individually tailored, progressive exercise compared with best practice advice, with or without corticosteroid injection, in adults with a rotator cuff disorder. This article describes the statistical analysis plan for the GRASP randomised controlled trial.Methods/designGRASP is a multicentre randomised controlled trial using a 2 × 2 factorial design. Adults aged ≥ 18 years with a new episode of shoulder pain related to a rotator cuff disorder, not currently receiving physiotherapy or being considered for surgery, are randomised (centralised computer-generated 1:1:1:1 allocation ratio) to one of four interventions: (1) progressive exercise (up to 6 physiotherapy sessions), (2) best practice advice (one physiotherapy session), (3) subacromial corticosteroid injection then progressive exercise and (4) subacromial corticosteroid injection then best practice advice. The primary outcome is the mean difference in Shoulder Pain and Disability Index (SPADI) total score over 12 months. Secondary outcomes are as follows: pain and function SPADI subdomains, health-related quality of life (EuroQol EQ-5D-5L), sleep disturbance, return to activity, global impression of change, health resource use, out-of-pocket expenses and work disability. Here, we describe in detail the following: sample size calculation, descriptive statistics of the primary and secondary outcomes, statistical models used for the analysis of the main outcomes, handling of missing data, planned sensitivity and subgroup analyses. This pre-specified statistical analysis plan was written and submitted without prior knowledge of the trial results.DiscussionPublication of the statistical analysis plan for the GRASP trial aims to reduce the risk of outcome reporting bias and increase transparency of the data analysis. Any deviations or changes to the current SAP will be described and justified in the final study report and any results publications.Trial registrationInternational Standard Randomised Controlled Trial Number ISRCTN16539266 . Registered on 14 June 2016. EudraCT number 2016-002991-28. Registered on 12 June 2016.

Project description:OBJECTIVE:To compare the effects of a programme of load management education plus exercise, corticosteroid injection use, and no treatment on pain and global improvement in individuals with gluteal tendinopathy. DESIGN:Prospective, three arm, single blinded, randomised clinical trial. SETTING:Brisbane and Melbourne, Australia. PARTICIPANTS:Individuals aged 35-70 years, with lateral hip pain for more than three months, at least 4/10 on the pain numerical rating scale, and gluteal tendinopathy confirmed by clinical diagnosis and magnetic resonance imaging; and with no corticosteroid injection use in previous 12 months, current physiotherapy, total hip replacement, or neurological conditions. INTERVENTIONS:A physiotherapy led education and exercise programme of 14 sessions over eight weeks (EDX; n=69), one corticosteroid injection (CSI; n=66), and a wait and see approach (WS; n=69). MAIN OUTCOMES:Primary outcomes were patient reported global rating of change in hip condition (on an 11 point scale, dichotomised to success and non-success) and pain intensity in the past week (0=no pain, 10=worst pain) at eight weeks, with longer term follow-up at 52 weeks. RESULTS:Of 204 randomised participants (including 167 women; mean age 54.8 years (standard deviation 8.8)), 189 (92.6%) completed 52 week follow-up. Success on the global rating of change was reported at eight weeks by 51/66 EDX, 38/65 CSI, and 20/68 WS participants. EDX and CSI had better global improvement scores than WS (risk difference 49.1% (95% confidence interval 34.6% to 63.5%), number needed to treat 2.0 (95% confidence interval 1.6 to 2.9); 29.2% (13.2% to 45.2%), 3.4 (2.2 to 7.6); respectively). EDX had better global improvement scores than CSI (19.9% (4.7% to 35.0%); 5.0 (2.9 to 21.1)). At eight weeks, reported pain on the numerical rating scale was mean score 1.5 (standard deviation 1.5) for EDX, 2.7 (2.4) for CSI, and 3.8 (2.0) for WS. EDX and CSI participants reported less pain than WS (mean difference -2.2 (95% confidence interval -2.89 to -1.54); -1.2 (-1.85 to -0.50); respectively), and EDX participants reported less pain than CSI (-1.04 (-1.72 to -0.37)). Success on the global rating of change was reported at 52 weeks by 51/65 EDX, 36/63 CSI, and 31/60 WS participants; EDX was better than CSI (20.4% (4.9% to 35.9%); 4.9 (2.8 to 20.6)) and WS (26.8% (11.3% to 42.3%); 3.7 (2.4 to 8.8)). Reported pain at 52 weeks was 2.1 (2.2) for EDX, 2.3 (1.9) for CSI, and 3.2 (2.6) for WS; EDX did not differ from CSI (-0.26 (-1.06 to 0.55)), but both treatments did better than WS (1.13 (-1.93 to -0.33); 0.87 (-1.68 to -0.07); respectively). CONCLUSIONS:For gluteal tendinopathy, education plus exercise and corticosteroid injection use resulted in higher rates of patient reported global improvement and lower pain intensity than no treatment at eight weeks. Education plus exercise performed better than corticosteroid injection use. At 52 week follow-up, education plus exercise led to better global improvement than corticosteroid injection use, but no difference in pain intensity. These results support EDX as an effective management approach for gluteal tendinopathy. TRIAL REGISTRATION:Prospectively registered at the Australian New Zealand Clinical Trials Registry (ACTRN12612001126808).

Project description:BackgroundShoulder complaints are common and the recommended first-line treatment is exercise therapy. However, it remains unknown if increased shoulder pain after an exercise session is a barrier for subsequent exercise dose, particularly in people with high fear-avoidance beliefs. Such knowledge could indicate ways to optimise shoulder rehabilitation. The aim was to examine whether increased shoulder pain across an exercise session was associated with a lower subsequent exercise dose, and if high fear-avoidance beliefs exaggerated this association.MethodsWe conducted a prospective cohort study using data from a randomised controlled trial in Central Denmark Region 2017-2019. Participants were employees (n = 79) with shoulder complaints and high occupational shoulder exposures. The intervention was a home-based or partly supervised exercise programme lasting 2-3 months. Linear mixed models were used to examine the associations between change in shoulder pain and exercise dose (number of repetitions, progression level (1-3), resistance level (1-3), and time until next exercise session [days]).ResultsAt baseline, the participants had a median pain intensity at rest of 2 on a numerical rating scale (0-10). For a 1-cm increase in pain on a visual analogue scale (0-10 cm) during an exercise session, the subsequent number of repetitions, progression level and resistance level were - 1.3 (95% confidence interval [CI] - 3.4 to 0.9), 0.0 (95% CI - 0.1 to 0.0) and - 0.0 (95% CI - 0.1 to 0.0), respectively. Likewise, the time until next exercise session was - 0.6 (95% CI - 2.4 to 1.3) days for a 1-cm increase. There were no interactions with fear-avoidance beliefs.ConclusionIncreased pain across an exercise session was not associated with subsequent exercise dose, regardless of fear-avoidance beliefs, among employees with shoulder complaints and high occupational shoulder exposures.Trial registrationThe trial was registered at Clinicaltrials.gov 19/05/2017 (ID: NCT03159910).