Anti-TNF (adalimumab) injection for the treatment of pain-predominant early-stage frozen shoulder: the Anti-Freaze-Feasibility randomised controlled trial.

OBJECTIVE: The Anti-Freaze-F (AFF) trial assessed the feasibility of conducting a definitive trial to determine whether intra-articular injection of adalimumab can reduce pain and improve function in people with pain-predominant early-stage frozen shoulder. DESIGN: Multicentre, randomised feasibility trial, with embedded qualitative study. SETTING: Four UK National Health Service (NHS) musculoskeletal and related physiotherapy services. PARTICIPANTS: Adults ≥18 years with new episode of shoulder pain attributable to early-stage frozen shoulder. INTERVENTIONS: Participants were randomised (centralised computer generated 1:1 allocation) to either ultrasound-guided intra-articular injection of: (1) adalimumab (160 mg) or (2) placebo (saline (0.9% sodium chloride)). Participants and outcome assessors were blinded to treatment allocation. Second injection of allocated treatment (adalimumab 80 mg) or equivalent placebo was administered 2-3 weeks later. PRIMARY FEASIBILITY OBJECTIVES: (1) Ability to screen and identify participants; (2) willingness of eligible participants to consent and be randomised; (3) practicalities of delivering the intervention; (4) SD of the Shoulder Pain and Disability Index (SPADI) score and attrition rate at 3 months. RESULTS: Between 31 May 2022 and 7 February 2023, 156 patients were screened of whom 39 (25%) were eligible. The main reasons for ineligibility were other shoulder disorder (38.5%; n=45/117) or no longer in pain-predominant frozen shoulder (33.3%; n=39/117). Of the 39 eligible patients, nine (23.1%) consented to be randomised (adalimumab n=4; placebo n=5). The main reason patients declined was because they preferred receiving steroid injection (n=13). All participants received treatment as allocated. The mean time from randomisation to first injection was 12.3 (adalimumab) and 7.2 days (placebo). Completion rates for patient-reported and clinician-assessed outcomes were 100%. CONCLUSION: This study demonstrated that current NHS musculoskeletal physiotherapy settings yielded only small numbers of participants, too few to make a trial viable. This was because many patients had passed the early stage of frozen shoulder or had already formulated a preference for treatment. TRIAL REGISTRATION NUMBER: ISRCTN 27075727, EudraCT 2021-03509-23, ClinicalTrials.gov NCT05299242 (REC 21/NE/0214).

Exercise treatments for lumbar spinal stenosis: A systematic review and intervention component analysis of randomised controlled trials.

OBJECTIVE: To analyse the components used in exercise interventions for people with symptoms of neurogenic claudication due to lumbar spinal stenosis and identify components associated with successful interventions. DATA SOURCES: Eligible papers published up to April 2023 from MEDLINE, EMBASE, CINAHL, PEDro, CENTRAL, Web of Science, and trial registry websites. REVIEW METHODS: Literature searches were performed by an Information Specialist. We searched for randomised trials evaluating exercise interventions for people with neurogenic claudication symptoms (the primary symptom of lumbar spinal stenosis). Two authors independently performed study selection, data extraction, and quality assessments using the Cochrane Risk of Bias tool Version 2 and the TIDieR checklist for intervention reporting. Details of intervention components were extracted, tabulated, and synthesised using an intervention component analysis approach. RESULTS: We found thirteen trials reporting 23 exercise interventions delivered to 1440 participants. These featured 60 different components. Most exercise interventions included supervision and flexion-based exercises. Balance exercises were rarely included. Exercise components featured more frequently in successful interventions included stretches, strength or trunk muscle exercises, fitness exercises, especially cycling, and psychologically informed approaches. Interpretation is limited by low study numbers and heterogeneity. No conclusions could be drawn about exercise supervision or dose. DISCUSSION: Exercise interventions for people with neurogenic claudication typically feature multiple components. Common features such as supervision, lumbar flexion, and aerobic fitness exercises and also less common features such as stretches, strengthening exercises, and psychologically informed approaches warrant consideration for inclusion when designing and optimising exercise interventions for people with lumbar spinal stenosis.

Experiences of people with hand osteoarthritis and perceptions of clinicians and carers on quality of life and treatment services: A qualitative synthesis.

Introduction: We aimed to synthesise the experiences of people living with hand osteoarthritis (HOA) and the perceptions of clinicians and carers relating to the quality of life and treatment services. Methods: We undertook a systematic search on MEDLINE, Embase, and CINAHL electronic databases for qualitative studies in HOA. We used the Critical Appraisal Skills Programme (CASP) checklist to assess methodological quality and thematically-synthesise the findings. We used GRADE-CERQual (Grading of Recommendations Assessment, Development, and Evaluation- Confidence in the Evidence from Reviews of Qualitative Research) to assess the quality of the evidence. Results: We identified 13 studies involving people with HOA (288 women and 39 men, average age 61.4 years) and clinicians. Five themes were identified from studies involving people with HOA: i) My hands are painful whenever I use them; ii) It stops me doing everyday activities; iii) It stops me doing things I value; iv) It's psychologically challenging and v) I find ways of doing things. The quality of evidence was moderate except for pain with low quality of evidence. Most studies were conducted in Europe and the United Kingdom with participants recruited predominantly from hospital settings. We were not able to synthesise the three studies that involved clinicians as each explored different topics of HOA. There were no studies that involved carers. Conclusions: Our findings highlighted the impact of HOA in various areas of life and the need for personalised psychological support in practice.

Implementation of a Web-Based Resilience Enhancement Training for Nurses: Pilot Randomized Controlled Trial.

BACKGROUND: Global workforce challenges faced by health care providers are linked to low levels of job satisfaction, recruitment, retention, and well-being, with detrimental impacts on patient care outcomes. Resilience-building programs can provide support for staff who endure highly stressful environments, enhance resilience, and support recruitment and retention, with web-based formats being key to increasing accessibility. OBJECTIVE: We aimed to examine participants' engagement with a newly developed Resilience Enhancement Online Training for Nurses (REsOluTioN), explore its acceptability, and compare levels of resilience and psychological well-being in nurses who completed REsOluTioN with those who did not. METHODS: We carried out a pilot randomized trial (1:1), conducted at a single site (mental health and community trust in South England) between August 2021 and May 2022. Local research ethics approvals were obtained. Nurses were invited to participate and were randomly assigned to a waitlist group or REsOluTioN group. Training lasted for 4 weeks, consisting of prereading, web-based facilitated sessions, and mentorship support. We evaluated trial engagement, acceptability of training, and pre-post changes in resilience, measured by the Brief Resilience Scale, and psychological well-being, measured by the Warwick Edinburgh Mental Wellbeing Scale. Qualitative participant feedback was collected. Consolidated Standards of Reporting Trials 2010 extension guidelines for reporting pilot and feasibility trials were used. RESULTS: Of 108 participants recruited, 93 completed the study. Participants' mean age was 44 (SD 10.85) years. Most participants were female (n=95, 88.8%), White (n=95, 88.8%), and worked in community settings (n=91, 85.0%). Sixteen facilitated and 150 mentoring sessions took place. Most REsOluTioN program participants reported the sessions helped improve their resilience (n=24, 72.8%), self-confidence (n=24, 72.7%), ability to provide good patient care (n=25, 75.8%), relationships with colleagues (n=24, 72.7%), and communication skills (n=25, 75.8%). No statistically significant differences between training and control groups and time on well-being (F1,91=1.44, P=.23, partial η2=0.02) and resilience scores (F1,91=0.33, P=.57, partial η2=0.004) were revealed; however, there were positive trends toward improvement in both. Nurse participants engaged with the REsOluTioN program and found it acceptable. Most found web-based training and mentoring useful and enjoyed learning, reflection, networking, and participatory sessions. CONCLUSIONS: The REsOluTioN program was acceptable, engaging, perceived as useful, and nurses were keen for it to be implemented to optimize resilience, psychological health, communication, and workplace environments. The study has evidenced that it is acceptable to implement web-based resilience programs with similar design features within busy health care settings, indicating a need for similar programs to be carefully evaluated. Mentorship support may also be a key in optimizing resilience. Trial limitations include small sample size and reduced statistical power; a multicenter randomized controlled trial could test effectiveness of the training on a larger scale. TRIAL REGISTRATION: ClinicalTrials.gov NCT05074563; https://clinicaltrials.gov/ct2/show/NCT05074563. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/37015.

It's What We Do: Experiences of UK Nurses Working during the COVID-19 Pandemic: Impact on Practice, Identity and Resilience.

The COVID-19 pandemic increased pressure on a nursing workforce already facing high levels of stress, burnout, and fatigue in the United Kingdom (UK) and internationally. The contribution of nurses to keeping the public safe was widely recognised as they met the challenges of delivering complex patient care during the healthcare crisis. However, the psychological impact of this on nurses' health and wellbeing has been substantial, and the number of nurses leaving the profession in the UK is rising. The aim of this study was to explore the experiences of nurses working during the COVID-19 pandemic and the impact of this on their psychological health, wellbeing and resilience. The study is part of a wider project to develop and pilot an online resilience intervention for nurses during COVID-19. Five focus groups with 22 nurses were carried out online. Data was analysed thematically using the Framework Method. Four key themes relating to positive and negative impacts of working during the pandemic were identified: Rapid changes and contexts in flux; loss and disruption; finding opportunities and positive transformation; and reinforcing and strengthening identity. Implications for coping and resilience in nursing, nursing identities and workforce development are discussed.

Longitudinal qualitative study of living with neurogenic claudication.

OBJECTIVES: Neurogenic claudication (NC) causes pain and reduced mobility, particularly in older people, and can negatively affect mental and social well-being, so limiting successful ageing. This qualitative study explored how people with NC changed over 12 months. DESIGN: A longitudinal qualitative study using semi-structured interviews. SETTING: Participants were recruited from a UK clinical trial of a physiotherapy intervention for NC. PARTICIPANTS: Interviews were undertaken at baseline, 1 month after receiving any intervention and at 12 months. We analysed 30 sets of three interviews. RESULTS: Interview data were summarised for each time point into biopsychosocial domains: pain, mobility and activities of daily living, psychological impact, and social and recreational participation. Through comparative analysis we explored participant trajectories over time.Progressive improvement in at least one domain was experienced by 13 participants, but there was variability in trajectories with early improvements that remained the same, transient changes and no change also commonly observed.Eleven participants described co-present improvement trajectories in all domains. Three participants described co-present improvement in all domains except participation; one had never stopped their participation and two had unattainable expectations. Five participants described co-present improvement in one domain and deterioration in another and 14 participants described co-present no change in one domain and change in another.There was evidence of interaction between domains; for example, improved mobility led to improved participation and for some participants, specific factors influenced change. Of the 15 participants who experienced improved participation, 10 reported improvements in all other domains and five participants did not; for two, pain did not prevent participation, one used a walking aid and two had a positive psychological outlook. CONCLUSION: The daily lived experiences of older adults with NC are variable and include interaction between biopsychosocial domains. Therapist understanding of these trajectories and their interactions may help to provide personalised therapy TRIAL REGISTRATION NUMBER: ISRCTN12698674.

Resilience Enhancement Online Training for Nurses (REsOluTioN): Protocol for a Pilot Randomized Controlled Trial.

BACKGROUND: Globally, nurses are facing increased pressure to provide high-quality complex patient care within environments with scarce resources in terms of staffing, infrastructure, or financial reward. The strain and demand on the psychological health and well-being of nurses during COVID-19 has been substantial, with many experiencing burnout; as such, interventions to enhance resilience within the workplace are required. A face-to-face resilience enhancement training program for nurses that was effective in improving resilience levels was translated into a 4-week online training program, Resilience Enhancement Online Training for Nurses (REsOluTioN), to enable greater accessibility for nurses. OBJECTIVE: This study aims to compare levels of resilience, psychological health, and well-being in nurses before and after the online resilience training compared to a wait list control group. It will also explore participants' engagement with the trial and their acceptability of the online training. METHODS: This is a two-arm, parallel, randomized controlled trial with a 6-week follow-up period. Up to 100 registered nonagency nurses working at a National Health Service hospital trust in South England will be recruited. Four cohorts will run, and participants will be randomized into a wait list control group or to REsOluTioN. Pre- and postonline surveys will collect study outcome measure data. In the REsOluTioN arm, data will be collected on the perceived usefulness of the online training via an online survey. Institutional and health research authority approvals have been obtained. RESULTS: REsOluTioN will aim to empower nurses to maintain and enhance their resilience while working under challenging clinical conditions. The online training will be interactive with input from mentors, health care leaders, and peers to promote engagement and enhanced communication, and will create a forum where nurses can express their views and concerns, without hierarchical infrastructures inhibiting them. This can increase self-knowledge and learning around workplace resilience coping strategies and provide a safe space to validate feelings through mentorship and peer support. Findings will be reported in accordance with the CONSORT (Consolidated Standards of Reporting Trials) guidelines. The trial is now finished and was conducted between August 2021 and May 2022. CONCLUSIONS: The REsOluTioN trial will enable preliminary data to be gathered to indicate the online training's effectiveness in enhancing nurses' resilience in the workplace, with the potential for larger scale follow-up studies to identify its value to nurses working across a range of health care settings. TRIAL REGISTRATION: ClinicalTrials.gov NCT05074563; https://clinicaltrials.gov/ct2/show/NCT05074563. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/37015.

A qualitative study exploring clinicians' views on clinical trials in thumb carpometacarpal joint osteoarthritis.

AIMS: Osteoarthritis (OA) affecting the thumb carpometacarpal joint (CMCJ) is a common painful condition. In this study, we aimed to explore clinicians' approach to management with a particular focus on the role of specific interventions that will inform the design of future clinical trials. METHODS: We interviewed a purposive sample of 24 clinicians, consisting of 12 surgeons and 12 therapists (four occupational therapists and eight physiotherapists) who managed patients with CMCJ OA. This is a qualitative study using semi-structured, online interviews. Interviews were audio-recorded, transcribed verbatim, and analyzed using thematic analysis. RESULTS: A total of 14 themes were developed, six of which were developed relating to the clinical management of CMCJ OA: 1) A flexible 'ladder' approach starting with conservative treatment first; 2) The malleable role of steroid injection; 3) Surgery as an invasive and risky last resort; 4) A shared and collaborative approach; 5) Treating the whole person; and 6) Severity of life impact influences treatment. The remaining eight themes were developed relating to clinical trial barriers and facilitators: 1) We need to embrace uncertainty; 2) You are not losing out by taking part; 3) It is difficult to be neutral about certain treatments; 4) Difficult to recruit to 'no treatment' ; 5) Difficult to recruit to a trial comparing no surgery to surgery; 6) Patients are keen to participate in research; 7) Burden on staff and participants; and 8) A enthusiasm for a variety of potential trial arms. CONCLUSION: Our findings contribute to a better understanding of how clinicians manage thumb CMCJ OA in their practice settings. Our study also provides useful insights informing the design of randomized clinical trials involving steroid injections and surgery in people with thumb CMCJ OA. Cite this article: Bone Jt Open 2022;3(4):321-331.

Flexibility and resistance exercises versus usual care for improving pain and function after distal radius fracture in adults aged 50 years or over: protocol for the WISE randomised multicentre feasibility trial.

BACKGROUND: Distal radius fractures represent about 1 in 5 of all fractures treated in UK hospitals. Most distal radius fractures occur in women aged 50 years or over after a fall. Distal radius fractures are managed using splints or casting, some are also treated with surgical fixation. Patients often experience long-term muscle weakness of the hand and arm that may impact their ability to do daily activities such as personal hygiene, routine household chores and food preparation. We propose a structured and tailored flexibility and resistance exercise programme for the hand and arm supplemented with behaviour change strategies to help perform daily exercise. The main aim of our study is to assess the feasibility of conducting a definitive randomised controlled trial. METHODS: This study is a multicentre, parallel-group individually randomised feasibility trial. We will recruit a minimum of 72 adults aged 50 years or over with distal radius fracture treated surgically or non-surgically from at least three UK National Health Service (NHS) hospitals. They will be randomised 1:1:1 to receive usual care, usual care and independent exercise with a single therapy session or usual care and supervised exercise with three therapy sessions over 12 weeks. Our primary feasibility objectives are (1) patient engagement assessed by recruitment, (2) acceptability of the interventions assessed by adherence and patient and clinician experience and (3) retention of participants in the trial. Outcome measures will be assessed at baseline, 3 months and at 6 months after randomisation. A qualitative sub-study will explore the experiences of the trial participants and therapists delivering the exercises. DISCUSSION: A definitive trial will be considered feasible without major modifications if our progression criteria are met. If successful, the findings will inform the design of a future definitive RCT to evaluate the clinical and cost-effectiveness of the WISE exercise programme. TRIAL REGISTRATION: ISRCTN12290145 .

The online version of an evidence-based hand exercise program for people with rheumatoid arthritis: A mixed-method, proof-of-concept study.

INTRODUCTION: The Strengthening And stretching for Rheumatoid Arthritis of the Hand (SARAH) program is a tailored, 12-week hand and arm exercise program recommended in the National Institute for Health and Care Excellence guidelines. It includes seven mobility exercises and four strength exercises against resistance. An online version of the SARAH program (mySARAH) has been developed to allow direct access for people with rheumatoid arthritis. PURPOSE: The purpose of this study was to assess the feasibility, acceptability, and clinical impact of mySARAH in people with rheumatoid arthritis. STUDY DESIGN: This is a mixed-method, proof-of-concept study. METHODS: mySARAH is a self-guided, online version of the SARAH program with six exercise training and review sessions. Participants were observed as they worked through four of the six online sessions. They were also asked to demonstrate the SARAH exercises. Participants undertook two sessions independently at home. At the baseline and 12 weeks, hand pain, hand function, and grip strength were measured. At 12 weeks, feedback on mySARAH, and perceived recovery were also collected. Approximately one month later, a telephone follow-up was conducted to explore participants' experiences with mySARAH. Pain, hand function, and perceived recovery were also assessed. RESULTS: Eleven participants (males/females: 3/8) with a median (interquartile range) age of 63 (17) years took part. Six participants completed all mySARAH sessions. About 512 exercise and load-setting demonstrations were observed and 491 (96%) were performed correctly. Improvements in grip strength and hand function were observed with no increase in pain. Most of the participants reported improvement and provided positive feedback. All participants perceived mySARAH as a useful resource. Features to improve the online exercise diary such as recording and tracking exercise dose and face-to-face or remote support by phone or Skype from health professionals were suggested to optimize user engagement. CONCLUSIONS: Initial evaluation of mySARAH indicates that mySARAH was feasible, acceptable, and beneficial to participants. Further iteration and evaluation are needed before large-scale implementation.