Sensory training system for use at home by people with complex regional pain syndrome in England: protocol for a proof-of-concept study.

INTRODUCTION: Complex regional pain syndrome (CRPS) is a disabling and distressing chronic pain condition characterised by a range of sensory, motor, autonomic and trophic symptoms. UK guidelines recommend therapy interventions to help normalise touch perception through self-administered tactile and thermal desensitisation activities. Interventions have been developed, aiming to help individuals broaden their sensory experience, thereby relieving chronic pain. However, therapy-led interventions often experience practical constraints and poor adherence. In response, a sensory training system (STS) device has been designed for unsupervised independent home-use. METHODS: This proof-of-concept study aims to explore whether people with CRPS use the device at home for 30 minutes a day for 30 days. Secondary aims are to determine whether the STS device will change tactile acuity and perceived levels of pain intensity, pain interference, sensitivity or feelings towards the affected limb. We will seek to recruit 20 eligible participants. Participants will be asked to measure tactile acuity using a two-point discrimination assessment, complete an online questionnaire before and after use of the device and complete a daily diary. On completion of the 30-day use, participants will be invited to take part in a semi-structured interview to explore their experiences of using the device. ANALYSIS: Pain intensity and pain interference will be scored using the online Assessment Center Scoring Service or using the look-up table in the PROMIS scoring manual. The remaining questionnaire data, including tactile acuity results, and device-use data, including frequency and duration of use, will be analysed using descriptive statistics. Qualitative data will be thematically analysed. ETHICS AND DISSEMINATION: London-Stanmore Research Ethics Committee provided a favourable opinion on 19 April 2021 (ref 21/LO/0200). The NHS Health Research Authority, UK, approved this study on 7 June 2021. Dissemination will include peer-reviewed publications, presentations at conferences, social media and reports to the funder and patient charities. TRIAL REGISTRATION NUMBER: ISRCTN89099843.

Optimising management of complex regional pain syndrome to improve clinical outcomes throughout the therapy care pathway in England: Protocol for a qualitative interview and observational study with patients and clinicians.

INTRODUCTION: Complex Regional Pain Syndrome (CRPS) is a disabling and distressing chronic pain condition characterised by a range of sensory, motor, autonomic and trophic symptoms. Guidelines recommend early referral for therapies that promote movement of the painful limb. However, evidence suggests a lack of defined therapy pathways for CRPS. AIMS: The current study aims to explore CRPS therapy management in centres of excellence in England, and outside of these settings, to understand what facilitates and hinders best practice. The overall aim is to develop a draft stratified package of care to expedite patient access to optimal CRPS therapy across the management pathway. METHODS AND ANALYSIS: Semi-structured interviews will be conducted with therapists working in CRPS centres of excellence and with therapists in other settings. Observations of therapy interventions in CRPS centres of excellence and interviews with patients who have received this care, will also help to identify potential key care package components. Interview data will be analysed using thematic analysis, mapped to the Theoretical Domains Framework (TDF), and Intervention Mapping Adapt (IMA) framework. Observations will be described and documented using the TDF headings. CONCLUSION: A triangulation protocol for qualitative health research will be used to integrate all data. Online stakeholder events will be held using consensus methods to agree a draft package of care for future implementation following further refinement, testing and evaluation. CLINICAL TRIAL REGISTRATION: The trial was registered with ISRCTN registry on 24 February 2022 (ISRCTN16917807).

A feasibility randomised controlled trial of a Fibromyalgia Self-management Programme for adults in a community setting with a nested qualitative study (FALCON).

BACKGROUND: Fibromyalgia is a condition associated with widespread musculoskeletal pain, fatigue and sleep problems. Fibromyalgia treatment guidelines recommend non-pharmacological interventions and the development of self-management skills. An example of a programme that fits these guidelines is the Fibromyalgia Self-management Programme (FSMP) which consists of one 2.5-hour weekly session over six successive weeks and includes education about fibromyalgia, goal setting, pacing, sleep hygiene and nutritional advice. The FSMP is currently provided in a secondary care hospital setting and co-delivered by a multidisciplinary team. Delivery in a primary care setting has the potential to improve the accessibility of the programme to people with fibromyalgia. Therefore, this feasibility study aimed to determine the practicality and acceptability of conducting a future definitive randomised controlled trial of the FSMP in a community setting. METHOD: An exploratory, parallel-arm, one-to-one, randomised controlled trial. Participants were recruited from general practices across South West England, and the FSMP was co-delivered by physiotherapists and occupational therapists across two community sites. To determine the outcome measures for a future definitive trial several were tested. The Revised Fibromyalgia Impact Questionnaire, Arthritis Self-Efficacy Scale-8, Chalder Fatigue Scale, Short form 36, 5-Level EQ-5D version and Jenkins Sleep Scale were collected at baseline, 6 weeks and 6 months. Semi-structured interviews were conducted with patient participants, occupational therapists and physiotherapists to explore the acceptability and feasibility of delivering the FSMP in a community setting. RESULTS: A total of 74 participants were randomised to the FSMP intervention (n = 38) or control arm (n = 36). Attrition from the trial was 42% (31/74) at 6 months. A large proportion of those randomised to the intervention arm (34%, 13/38) failed to attend any sessions with six of the 13 withdrawing before the intervention commenced. The proportion of missing values was small for each of the outcome measures. Three overarching themes were derived from the interview data; (1) barriers and facilitators to attending the FSMP; (2) FSMP content, delivery and supporting documentation; and (3) trial processes. CONCLUSION: It is feasible to recruit people with fibromyalgia from Primary Care to participate in a randomised controlled trial testing the FSMP in a community setting. However, improvement in trial attrition and engagement with the intervention is needed. TRIAL REGISTRATION: The trial is registered with ISRCTN registry and was assigned on 29/04/2019. The registration number is ISRCTN10824225.

A feasibility randomised controlled trial of a fibromyalgia self-management programme in a community setting with a nested qualitative study (FALCON): Study protocol.

BACKGROUND: Fibromyalgia (FM) is a complex long-term condition associated with chronic widespread pain, fatigue, sleep problems, memory and concentration difficulties and irritable bowel syndrome. Current guidelines for the treatment of FM recommend nonpharmacological interventions. The Fibromyalgia Self-Management Programme (FSMP) is a nonpharmacological, multidisciplinary exercise and education group intervention. It aims to provide education and teach core skills, enabling those affected by FM to self-manage. The FSMP is currently codelivered by a multidisciplinary team within a secondary care service. The aim of this feasibility randomised controlled trial (RCT) is to determine the practicality and acceptability of delivering the FSMP in a community setting, informing a future RCT of effectiveness. METHODS: The feasibility RCT aims to recruit 70 people with FM. Participants will be randomised to either a community FSMP or control arm. All participants will be asked to complete six patient-reported outcome measures and one health economics questionnaire on three occasions; baseline, 6 weeks (end of the intervention) and 6 months. Between 12 and 16 participants and four therapists delivering the FSMP will be invited to take part in a semi-structured interview to explore their experiences of the FSMP. Patient participants will be purposively selected based upon key characteristics. ANALYSIS: Quantitative data will be analysed descriptively to summarise recruitment and attendance, participant reported outcomes and health economic data. Semi-structured interviews will be transcribed, anonymised and inductively coded. The codes will be grouped into categories and theoretically thematically analysed, comparing the results to existing literature. TRIAL REGISTRATION: The trial is registered with ISRCTN registry and was assigned on 29th of April 2020. The registration number is ISRCTN10824225.

Cumulative incidence, risk factors, and management of atrial fibrillation in patients receiving ibrutinib.

Atrial fibrillation (AF) has been reported in up to 16% of patients taking ibrutinib. Data regarding the management of AF in this patient population are limited, and stroke prevention poses a challenge because of increased risk of bleeding with ibrutinib treatment. Our study sought to describe the incidence of AF in adult patients treated with ibrutinib for a hematologic malignancy, assess management strategies, evaluate stroke and bleeding outcomes, and identify risk factors for occurrence. Of 582 patients treated with ibrutinib, 76 developed AF. With a median follow-up of 32 months, the estimated cumulative incidence at 6 months, 1 year, and 2 years was 5.9% (95% confidence interval [CI]: 4.2-8.0), 7.5% (95% CI: 5.5-9.9), and 10.3% (95% CI: 8.0-13.0), respectively. Median time to onset of AF was 7.6 months. History of AF and Framingham Heart Study (FHS) AF risk score were found to be significant risk factors for development of AF. Most patients were treated with rate control-only strategies (61.8%), and concomitant aspirin or anticoagulant therapy with ibrutinib was used in 52.6% and 28.9% of patients, respectively. One patient on aspirin developed symptoms consistent with stroke. Nine major bleeds were noted in 7 patients, and 34 clinically relevant nonmajor bleeds were noted in 24 patients. Twenty-one bleeds (4 major bleeds) occurred in 18 patients on aspirin, and 10 bleeds (all clinically relevant nonmajor bleeds) occurred in 6 patients with anticoagulant therapy. These results provide risk factor assessment, impact of management strategies, and outcomes of patients with AF on ibrutinib and serve as basis for formal guidelines.