Optimising physiotherapy for people with lateral elbow tendinopathy - Results of a mixed-methods pilot and feasibility randomised controlled trial (OPTimisE).

BACKGROUND: The OPTimisE intervention was developed to address uncertainty regarding the most effective physiotherapy treatment strategy for people with Lateral Elbow Tendinopathy (LET). OBJECTIVES: To assess the feasibility of conducting a fully-powered randomised controlled trial (RCT) evaluating whether the OPTimisE intervention is superior to usual physiotherapy treatment for adults with LET. DESIGN: A mixed-methods multi-centred, parallel pilot and feasibility RCT, conducted in three outpatient physiotherapy departments in the UK. METHOD: Patients were independently randomised 1:1 in mixed blocks, stratified by site, to the OPTimisE intervention or usual care. Outcomes were assessed using pre-defined feasibility progression criteria. RESULTS: 50 patients were randomised (22 Female, 28 Male), mean age 48 years (range 27-75). Consent rate was 71% (50/70), fidelity to intervention 89% (16/18), attendance rate in the OPTimisE group 82% (55/67) vs 85% (56/66) in usual care, outcome measure completion 81% (39/48) at six-month follow-up. There were no related adverse events. Patients and physiotherapists reported that the OPTimisE intervention was acceptable but suggested improvements to the trial design. 49 patients were recruited from physiotherapy referrals vs one from primary care records. Outcome measure return rates were higher when completed online (74%) compared to postal questionnaire (50%). Exploratory analysis showed improvements in both groups over time. CONCLUSIONS: It is methodologically feasible to conduct a fully powered RCT comparing the clinical and cost-effectiveness of the OPTimisE intervention versus usual physiotherapy treatment. Considering the similar improvements observed in both groups, careful consideration is needed regarding the priority research question to be addressed in future research.

Comparing an optimised physiotherapy treatment package with usual physiotherapy care for people with tennis elbow - protocol for the OPTimisE pilot and feasibility randomised controlled trial.

BACKGROUND: Physiotherapy is recommended for people with tennis elbow, but whilst a wide array of treatments is available, the optimal approach remains uncertain. We have therefore recently developed an optimised physiotherapy treatment package for tennis elbow based on a synthesis of the evidence, patient input and clinical consensus. It consists of detailed advice and education, a structured progressive exercise programme and provision of a counter-force elbow brace. Here, we report the protocol for our multicentre pilot and feasibility randomised controlled trial (RCT) designed to (a) examine the feasibility of our optimised physiotherapy treatment package and (b) to pilot trial processes for a future fully powered RCT to test clinical and cost-effectiveness compared with usual physiotherapy treatment. METHODS: A multicentre pilot and feasibility RCT will be conducted across three sites in England, recruiting up to 50 patients (or for a maximum of 12 months). Participants with tennis elbow, identified from physiotherapy clinic waiting lists and general practice surgeries, will be randomly allocated to receive the optimised physiotherapy treatment package or usual physiotherapy care. Analysis will focus on feasibility measures including consent rate, intervention fidelity, follow-up rate and outcome completion rate. A nested qualitative study will explore the acceptability of the study processes and patient and physiotherapist experiences of the new optimised intervention. DISCUSSION: This study will determine the feasibility of a new optimised physiotherapy treatment package for people with tennis elbow and pilot the processes for a future fully powered RCT. In the longer term, this treatment package may provide superior clinical outcomes for patients, in terms of pain and quality of life, and be more cost-effective for the health service. TRIAL REGISTRATION: Registered with the ISRCTN database 19/7/2021, https://www.isrctn.com/ISRCTN64444585.

A study comparing hyoscine hydrobromide and glycopyrrolate in the treatment of death rattle.

This study looked at the efficacy of drug treatment in managing death rattle in a 30-bedded specialist palliative care unit. The study was conducted in two phases. In the first, patients received hyoscine hydrobromide as the antimuscarinic; glycopyrrolate was used in the second phase. The patients in the two phases were well matched for diagnosis, age, sex and duration of death rattle. A noise score scale of 0-3 was used, which was separately validated using a verbal rating scale and noise-meter readings. Noise scores were taken at the start; 30 min after an antimuscarinic drug was administered; an hour after the initial injection if a repeat dose was given at 30 min; and 4-hourly thereafter. Drug charts of all patients with death rattle were analysed to ascertain the amount of each drug given and the cost. The incidence of death rattle was 44% in phase I, and 36% in phase II. The percentage of patients with reduced noise scores 30 min after one injection of hyoscine was significantly greater than after one dose of glycopyrrolate (56% vs 27%, P = 0.002). The need for a second injection after 30 min was less using hyoscine (33% vs 50%, P = 0.03). There was no statistically significant difference in improvement at 1 h, or at the last recorded score before death. A comparison of the cost of drug treatment using hyoscine or glycopyrrolate was made, and the potential reduction in cost per patient in the glycopyrrolate group was largely offset by increased expenditure on other drugs, especially diamorphine, midazolam and levomepromazine. The results of this study suggest that: (1) glycopyrrolate 0.2 mg is less effective at reducing death rattle than hyoscine hydrobromide 0.4 mg when assessed at 30 min, (2) the use of glycopyrrolate may lead to an increased need for other sedative or anti-emetic medication such as diamorphine, midazolam or levomepromazine, and (3) the cost benefit of using glycopyrrolate over hyoscine hydrobromide is a small part of the total drug budget, and may be less than anticipated due to the increased need of these other drugs.