Clinical and cost-effectiveness of individualised (early) patient-directed rehabilitation versus standard rehabilitation after surgical repair of the rotator cuff of the shoulder: protocol for a multicentre, randomised controlled trial with integrated Quintet Recruitment Intervention (RaCeR 2).

INTRODUCTION: Despite the high number of operations and surgical advancement, rehabilitation after rotator cuff repair has not progressed for over 20 years. The traditional cautious approach might be contributing to suboptimal outcomes. Our aim is to assess whether individualised (early) patient-directed rehabilitation results in less shoulder pain and disability at 12 weeks after surgical repair of full-thickness tears of the rotator cuff compared with current standard (delayed) rehabilitation. METHODS AND ANALYSIS: The rehabilitation after rotator cuff repair (RaCeR 2) study is a pragmatic multicentre, open-label, randomised controlled trial with internal pilot phase. It has a parallel group design with 1:1 allocation ratio, full health economic evaluation and quintet recruitment intervention. Adults awaiting arthroscopic surgical repair of a full-thickness tear are eligible to participate. On completion of surgery, 638 participants will be randomised. The intervention (individualised early patient-directed rehabilitation) includes advice to the patient to remove their sling as soon as they feel able, gradually begin using their arm as they feel able and a specific exercise programme. Sling removal and movement is progressed by the patient over time according to agreed goals and within their own pain and tolerance. The comparator (standard rehabilitation) includes advice to the patient to wear the sling for at least 4 weeks and only to remove while eating, washing, dressing or performing specific exercises. Progression is according to specific timeframes rather than as the patient feels able. The primary outcome measure is the Shoulder Pain and Disability Index total score at 12-week postrandomisation. The trial timeline is 56 months in total, from September 2022. TRIAL REGISTRATION NUMBER: ISRCTN11499185.

Exploring the experiences and perceptions of patients awaiting rotator cuff repair surgery: An integrated qualitative study within the POWER pilot and feasibility trial.

BACKGROUND: As waiting times for orthopaedic surgery increase, there have been calls to move from 'waiting lists' to 'preparation lists', to better prepare patients for surgery. In this context, a pilot randomised controlled trial (POWER) was conducted, comparing physiotherapist-led exercise to waiting-list control (usual care), for patients awaiting rotator cuff repair surgery. This qualitative study was integrated within the pilot trial. OBJECTIVES: Explore the experiences of adults awaiting rotator cuff repair surgery in the NHS. Explore the acceptability of the physiotherapist-led exercise intervention. Explore the barriers and enablers to recruitment, retention, and adherence. DESIGN: Integrated qualitative study with semi-structured telephone interviews. METHODS: Adults awaiting rotator cuff repair, consenting to participate in the trial were eligible. Sampling was purposive regarding age, gender, randomised allocation, and hospital site. Interviews were audio-recorded and transcribed. Data were analysed using Reflexive Thematic Analysis. RESULTS: 20 participants were recruited (age range 49-81 years; 12 male, 10 randomised to physiotherapist-led exercise). Many participants were unable to recall their experiences of trial processes; nonetheless, three themes were identified from the data: experience of shoulder pain and pathway to treatment; communication and decision-making in the context of rotator cuff repair surgery; and experiences of the POWER physiotherapist-led exercise intervention and processes. CONCLUSIONS: Patients experience significant burden due to shoulder pain. Their journey to surgery can be long, confusing, and associated with perceived abandonment. In a future trial, the intervention should offer opportunity for shared decision-making, optional exit from the surgical pathway, and an individualised exercise programme.

The cost-effectiveness of adding an ultrasound corticosteroid and local anaesthetic injection to advice and education for hip osteoarthritis.

OBJECTIVES: Evidence for the comparative cost-effectiveness of intra-articular corticosteroid injection in people with hip osteoarthritis (OA) remains unclear. This study investigated the cost-effectiveness of best current treatment (BCT) comprising advice and education plus a single ultrasound-guided intra-articular hip injection (USGI) of 40 mg triamcinolone acetonide and 4 ml 1% lidocaine hydrochloride (BCT+US-T) versus BCT alone. METHODS: A trial-based cost-utility analysis of BCT+US-T compared with BCT was undertaken over 6 months. Patient-level cost data were obtained, and effectiveness was measured in terms of quality-adjusted life years (QALYs), allowing the calculation of cost per QALY gained from a United Kingdom (UK) National Health Service (NHS) perspective. RESULTS: BCT+US-T was associated with lower mean NHS costs (BCT+US-T minus BCT: £-161.6, 95% CI: £-583.95 to £54.18) and small but significantly higher mean QALYs than BCT alone over 6 months (BCT+US-T minus BCT: 0.0487, 95% CI: 0.0091, 0.0886). In the base case, BCT+US-T was the most cost-effective and dominated BCT alone. Differences in total costs were driven by number of visits to NHS consultants, private physiotherapists, and chiropractors, and hip surgery, which were more common with BCT alone than BCT+US-T. CONCLUSION: Intra-articular corticosteroid injection plus BCT (BCT+US-T) for patients with hip OA results in lower costs and better outcomes, and is highly cost-effective, compared with BCT alone. TRIAL REGISTRATION: EudraCT: 2014-003412-37 (August 8, 2015) and registered with Current Controlled Trials: ISRCTN 50550256 (July 28, 2015). TRIAL PROTOCOL: Full details of the trial protocol can be found in the Supplementary Appendix, available with the full text of this article at https://bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-018-2153-0#citeas. DOI: doi.org/10.1186/s12891-018-2153-0.

Physiotherapist-led exercise versus usual care (waiting-list) control for patients awaiting rotator cuff repair surgery: A pilot randomised controlled trial (POWER).

BACKGROUND: Once a decision to undergo rotator cuff repair surgery is made, patients are placed on the waiting list. It can take weeks or months to receive surgery. There has been a call to move from waiting lists to 'preparation' lists to better prepare patients for surgery and to ensure it remains an appropriate treatment option for them. OBJECTIVE: To evaluate the feasibility, as measured by recruitment rates, treatment fidelity and follow-up rates, of a future multi-centre randomised controlled trial to compare the clinical and cost-effectiveness of undertaking a physiotherapist-led exercise programme while waiting for surgery versus usual care (waiting-list control). DESIGN: Two-arm, multi-centre pilot randomised controlled trial with feasibility objectives in six NHS hospitals in England. METHOD: Adults (n = 76) awaiting rotator cuff repair surgery were recruited and randomly allocated to a programme of physiotherapist-led exercise (n = 38) or usual care control (n = 38). RESULTS: Of 302 eligible patients, 76 (25%) were randomised. Of 38 participants randomised to physiotherapist-led exercise, 28 (74%) received the exercise programme as intended. 51/76 (67%) Shoulder Pain and Disability Index questionnaires were returned at 6-months. Of 76 participants, 32 had not received surgery after 6-months (42%). Of those 32, 20 were allocated to physiotherapist-led exercise; 12 to usual care control. CONCLUSIONS: A future multi-centre randomised controlled trial is feasible but would require planning for variable recruitment rates between sites, measures to improve treatment fidelity and opportunity for surgical exit, and optimisation of follow-up. A fully powered, randomised controlled trial is now needed to robustly inform clinical decision-making.

Predictors of outcome in sciatica patients following an epidural steroid injection: the POiSE prospective observational cohort study protocol.

INTRODUCTION: Sciatica can be very painful and, in most cases, is due to pressure on a spinal nerve root from a disc herniation with associated inflammation. For some patients, the pain persists, and one management option is a spinal epidural steroid injection (ESI). The aim of an ESI is to relieve leg pain, improve function and reduce the need for surgery. ESIs work well in some patients but not in others, but we cannot identify these patient subgroups currently. This study aims to identify factors, including patient characteristics, clinical examination and imaging findings, that help in predicting who does well and who does not after an ESI. The overall objective is to develop a prognostic model to support individualised patient and clinical decision-making regarding ESI. METHODS: POiSE is a prospective cohort study of 439 patients with sciatica referred by their clinician for an ESI. Participants will receive weekly text messages until 12 weeks following their ESIand then again at 24 weeks following their ESI to collect data on leg pain severity. Questionnaires will be sent to participants at baseline, 6, 12 and 24 weeks after their ESI to collect data on pain, disability, recovery and additional interventions. The prognosis for the cohort will be described. The primary outcome measure for the prognostic model is leg pain at 6 weeks. Prognostic models will also be developed for secondary outcomes of disability and recovery at 6 weeks and additional interventions at 24 weeks following ESI. Statistical analyses will include multivariable linear and logistic regression with mixed effects model. ETHICS AND DISSEMINATION: The POiSE study has received ethical approval (South Central Berkshire B Research Ethics Committee 21/SC/0257). Dissemination will be guided by our patient and public engagement group and will include scientific publications, conference presentations and social media.

Development and Validation of Multivariable Prediction Models for In-Hospital Death, 30-Day Death, and Change in Residence After Hip Fracture Surgery and the "Stratify-Hip" Algorithm.

BACKGROUND: To develop and validate the stratify-hip algorithm (multivariable prediction models to predict those at low, medium, and high risk across in-hospital death, 30-day death, and residence change after hip fracture). METHODS: Multivariable Fine-Gray and logistic regression of audit data linked to hospital records for older adults surgically treated for hip fracture in England/Wales 2011-14 (development n = 170 411) and 2015-16 (external validation, n = 90 102). Outcomes included time to in-hospital death, death at 30 days, and time to residence change. Predictors included age, sex, pre-fracture mobility, dementia, and pre-fracture residence (not for residence change). Model assumptions, performance, and sensitivity to missingness were assessed. Models were incorporated into the stratify-hip algorithm assigning patients to overall low (low risk across outcomes), medium (low death risk, medium/high risk of residence change), or high (high risk of in-hospital death, high/medium risk of 30-day death) risk. RESULTS: For complete-case analysis, 6 780 of 141 158 patients (4.8%) died in-hospital, 8 693 of 149 258 patients (5.8%) died by 30 days, and 4 461 of 119 420 patients (3.7%) had residence change. Models demonstrated acceptable calibration (observed:expected ratio 0.90, 0.99, and 0.94), and discrimination (area under curve 73.1, 71.1, and 71.5; Brier score 5.7, 5.3, and 5.6) for in-hospital death, 30-day death, and residence change, respectively. Overall, 31%, 28%, and 41% of patients were assigned to overall low, medium, and high risk. External validation and missing data analyses elicited similar findings. The algorithm is available at https://stratifyhip.co.uk. CONCLUSIONS: The current study developed and validated the stratify-hip algorithm as a new tool to risk stratify patients after hip fracture.

Moderators, Mediators, and Prognostic Indicators of Treatment With Hip Arthroscopy or Physical Therapy for Femoroacetabular Impingement Syndrome: Secondary Analyses From the Australian FASHIoN Trial.

BACKGROUND: Although randomized controlled trials comparing hip arthroscopy with physical therapy for the treatment of femoroacetabular impingement (FAI) syndrome have emerged, no studies have investigated potential moderators or mediators of change in hip-related quality of life. PURPOSE: To explore potential moderators, mediators, and prognostic indicators of the effect of hip arthroscopy and physical therapy on change in 33-item international Hip Outcome Tool (iHOT-33) score for FAI syndrome. STUDY DESIGN: Cohort study; Level of evidence, 2. METHODS: Overall, 99 participants were recruited from the clinics of orthopaedic surgeons and randomly allocated to treatment with hip arthroscopy or physical therapy. Change in iHOT-33 score from baseline to 12 months was the dependent outcome for analyses of moderators, mediators, and prognostic indicators. Variables investigated as potential moderators/prognostic indicators were demographic variables, symptom duration, alpha angle, lateral center-edge angle (LCEA), Hip Osteoarthritis MRI Scoring System (HOAMS) for selected magnetic resonance imaging (MRI) features, and delayed gadolinium-enhanced MRI of cartilage (dGEMRIC) score. Potential mediators investigated were change in chosen bony morphology measures, HOAMS, and dGEMRIC score from baseline to 12 months. For hip arthroscopy, intraoperative procedures performed (femoral ostectomy ± acetabular ostectomy ± labral repair ± ligamentum teres debridement) and quality of surgery graded by a blinded surgical review panel were investigated for potential association with iHOT-33 change. For physical therapy, fidelity to the physical therapy program was investigated for potential association with iHOT-33 change. RESULTS: A total of 81 participants were included in the final moderator/prognostic indicator analysis and 85 participants in the final mediator analysis after exclusion of those with missing data. No significant moderators or mediators of change in iHOT-33 score from baseline to 12 months were identified. Patients with smaller baseline LCEA (ß = -0.82; P = .034), access to private health care (ß = 12.91; P = .013), and worse baseline iHOT-33 score (ß = -0.48; P < .001) had greater iHOT-33 improvement from baseline to 12 months, irrespective of treatment allocation, and thus were prognostic indicators of treatment response. Unsatisfactory treatment fidelity was associated with worse treatment response (ß = -24.27; P = .013) for physical therapy. The quality of surgery and procedures performed were not associated with iHOT-33 change for hip arthroscopy (P = .460-.665 and P = .096-.824, respectively). CONCLUSION: No moderators or mediators of change in hip-related quality of life were identified for treatment of FAI syndrome with hip arthroscopy or physical therapy in these exploratory analyses. Patients who accessed the Australian private health care system, had smaller LCEAs, and had worse baseline iHOT-33 scores, experienced greater iHOT-33 improvement, irrespective of treatment allocation.

Comparison of Walking Biomechanics After Physical Therapist-Led Care or Hip Arthroscopy for Femoroacetabular Impingement Syndrome: A Secondary Analysis From a Randomized Controlled Trial.

BACKGROUND: Femoroacetabular impingement syndrome is characterized by chondrolabral damage and hip pain. The specific biomechanics used by people with femoroacetabular impingement syndrome during daily activities may exacerbate their symptoms. Femoroacetabular impingement syndrome can be treated nonoperatively or surgically; however, differential treatment effects on walking biomechanics have not been examined. PURPOSE: To compare the 12-month effects of physical therapist-led care or arthroscopy on trunk, pelvis, and hip kinematics as well as hip moments during walking. STUDY DESIGN: Secondary analysis of multi-centre, pragmatic, two-arm superiority randomized controlled trial subsample; Level of evidence, 1. METHODS: A subsample of 43 participants from the Australian Full randomised controlled trial of Arthroscopic Surgery for Hip Impingement versus best cONventional (FASHIoN trial) underwent gait analysis and completed the International Hip Outcome Tool (iHOT-33) at both baseline and 12 months after random allocation to physical therapist-led care (personalized hip therapy; n = 22; mean age 35; 41% female) or arthroscopy (n = 21; mean age 36; 48% female). Changes in trunk, pelvis, and hip biomechanics were compared between treatment groups across the gait cycle using statistical parametric mapping. Associations between changes in iHOT-33 and changes in hip kinematics across 3 planes of motion were examined. RESULTS: As compared with the arthroscopy group, the personalized hip therapy group increased its peak hip adduction moments (mean difference = 0.35 N·m/body weight·height [%] [95% CI, 0.05-0.65]; effect size = 0.72; P = .02). Hip adduction moments in the arthroscopy group were unchanged in response to treatment. No other between-group differences were detected. Improvements in iHOT-33 were not associated with changes in hip kinematics. CONCLUSION: Peak hip adduction moments were increased in the personalized hip therapy group and unchanged in the arthroscopy group. No biomechanical changes favoring arthroscopy were detected, suggesting that personalized hip therapy elicits greater changes in hip moments during walking at 12-month follow-up. Twelve-month changes in hip-related quality of life were not associated with changes in hip kinematics.

Multi-centre randomised controlled trial comparing arthroscopic hip surgery to physiotherapist-led care for femoroacetabular impingement (FAI) syndrome on hip cartilage metabolism: the Australian FASHIoN trial.

BACKGROUND: Arthroscopic surgery for femoroacetabular impingement syndrome (FAI) is known to lead to self-reported symptom improvement. In the context of surgical interventions with known contextual effects and no true sham comparator trials, it is important to ascertain outcomes that are less susceptible to placebo effects. The primary aim of this trial was to determine if study participants with FAI who have hip arthroscopy demonstrate greater improvements in delayed gadolinium-enhanced magnetic resonance imaging (MRI) of cartilage (dGEMRIC) index between baseline and 12 months, compared to participants who undergo physiotherapist-led management. METHODS: Multi-centre, pragmatic, two-arm superiority randomised controlled trial comparing physiotherapist-led management to hip arthroscopy for FAI. FAI participants were recruited from participating orthopaedic surgeons clinics, and randomly allocated to receive either physiotherapist-led conservative care or surgery. The surgical intervention was arthroscopic FAI surgery. The physiotherapist-led conservative management was an individualised physiotherapy program, named Personalised Hip Therapy (PHT). The primary outcome measure was change in dGEMRIC score between baseline and 12 months. Secondary outcomes included a range of patient-reported outcomes and structural measures relevant to FAI pathoanatomy and hip osteoarthritis development. Interventions were compared by intention-to-treat analysis. RESULTS: Ninety-nine participants were recruited, of mean age 33 years and 58% male. Primary outcome data were available for 53 participants (27 in surgical group, 26 in PHT). The adjusted group difference in change at 12 months in dGEMRIC was -59 ms (95%CI - 137.9 to - 19.6) (p = 0.14) favouring PHT. Hip-related quality of life (iHOT-33) showed improvements in both groups with the adjusted between-group difference at 12 months showing a statistically and clinically important improvement in arthroscopy of 14 units (95% CI 5.6 to 23.9) (p = 0.003). CONCLUSION: The primary outcome of dGEMRIC showed no statistically significant difference between PHT and arthroscopic hip surgery at 12 months of follow-up. Patients treated with surgery reported greater benefits in symptoms at 12 months compared to PHT, but these benefits are not explained by better hip cartilage metabolism. TRIAL REGISTRATION DETAILS: Australia New Zealand Clinical Trials Registry reference: ACTRN12615001177549 . Trial registered 2/11/2015.

Treatment targets of exercise for persistent non-specific low back pain: a consensus study.

OBJECTIVES: Despite several hundred previous randomised controlled trials (RCTs), the key treatment targets of exercise for persistent non-specific low back pain (NSLBP) remain unclear. This study aimed to generate consensus about the key treatment targets of exercise interventions for patients with NSLBP. DESIGN: Consensus was generated using modified nominal group technique in two, sequential, workshops. The results of a previous systematic review informed the first, national, workshop idea generation and the results of this workshop informed the second, international, workshop. The authors generated a starting list of 30 treatment targets from the systematic review. A pre-specified consensus threshold of 75% was used in the voting stage. PARTICIPANTS: Workshop participants included people with experience of using exercise to manage their persistent NSLBP, clinicians who prescribe exercise for persistent NSLBP, and researchers who design and evaluate exercise interventions in RCTs. All participants generated, voted and ranked the treatment targets in each workshop using an online platform. RESULTS: A total of 39 participants contributed to the consensus (15 in the national workshop and 24 in the international workshop), comprising two people with NSLBP, six clinicians and 31 researchers/clinicians. A total of 40 exercise treatment targets were generated, and 25 were retained after voting and ranking. The prioritised targets of exercise for persistent NSLBP were: improving function, improving quality of life, reducing pain, meeting patient-specific goals and reducing fear of movement. CONCLUSIONS: Future RCTs of exercise should specify the targets of their exercise intervention and consider assessing these treatment targets as well as including mediation analyses.

Protocol for a multi-site pilot and feasibility randomised controlled trial: Surgery versus PhysiothErapist-leD exercise for traumatic tears of the rotator cuff (the SPeEDy study).

BACKGROUND: Clinically, a distinction is made between types of rotator cuff tear, traumatic and non-traumatic, and this sub-classification currently informs the treatment pathway. It is currently recommended that patients with traumatic rotator cuff tears are fast tracked for surgical opinion. However, there is uncertainty about the most clinically and cost-effective intervention for patients with traumatic rotator cuff tears and further research is required. SPeEDy will assess the feasibility of a fully powered, multi-centre randomised controlled trial (RCT) to test the hypothesis that, compared to surgical repair (and usual post-operative rehabilitation), a programme of physiotherapist-led exercise is not clinically inferior, but is more cost-effective for patients with traumatic rotator cuff tears. METHODS: SPeEDy is a two-arm, multi-centre pilot and feasibility RCT with integrated Quintet Recruitment Intervention (QRI) and further qualitative investigation of patient experience. A total of 76 patients with traumatic rotator cuff tears will be recruited from approximately eight UK NHS hospitals and randomly allocated to either surgical repair and usual post-operative rehabilitation or a programme of physiotherapist-led exercise. The QRI is a mixed-methods approach that includes data collection and analysis of screening logs, audio recordings of recruitment consultations, interviews with patients and clinicians involved in recruitment, and review of study documentation as a basis for developing action plans to address identified difficulties whilst recruitment to the RCT is underway. A further sample of patient participants will be purposively sampled from both intervention groups and interviewed to explore reasons for initial participation, treatment acceptability, reasons for non-completion of treatment, where relevant, and any reasons for treatment crossover. DISCUSSION: Research to date suggests that there is uncertainty regarding the most clinically and cost-effective interventions for patients with traumatic rotator cuff tears. There is a clear need for a high-quality, fully powered, RCT to better inform clinical practice. Prior to this, we first need to undertake a pilot and feasibility RCT to address current uncertainties about recruitment, retention and number of and reasons for treatment crossover. TRIAL REGISTRATION: ClinicalTrials.gov ( NCT04027205 ) - Registered on 19 July 2019. Available via.

Rehabilitation following rotator cuff repair: A nested qualitative study exploring the perceptions and experiences of participants in a randomised controlled trial.

OBJECTIVE: To investigate acceptability, barriers to adherence with the interventions, and which outcome measures best reflect the participants' rehabilitation goals in a pilot and feasibility randomised controlled trial evaluating early patient-directed rehabilitation and standard rehabilitation, including sling immobilisation for four weeks, following surgical repair of the rotator cuff of the shoulder. DESIGN: Nested qualitative study. SETTING: Five English National Health Service Hospitals. SUBJECTS: Nineteen patient participants who had undergone surgical repair of the rotator cuff and 10 healthcare practitioners involved in the trial. METHOD: Individual semi-structured interviews. Data were analysed thematically. RESULTS: Four themes: (1) Preconceptions of early mobilisation; many participants were motivated to enter the trial for the opportunity of removing their sling and getting moving early. (2) Sling use and movement restrictions; for some, sling use for four weeks was unacceptable and contributed to their pain, rather than relieving it. (3) Tensions associated with early mobilisation; clinical tensions regarding early mobilisation and the perceived risk to the surgical repair were apparent. (4) Processes of running the trial; participants found the trial processes to be largely appropriate and acceptable, but withholding the results of the post-operative research ultrasound scan was contentious. CONCLUSION: Trial processes were largely acceptable, except for withholding results of the ultrasound scan. For some participants, use of the shoulder sling for a prolonged period after surgery was a reported barrier to standard rehabilitation whereas the concept of early mobilisation contributed tension for some healthcare practitioners due to concern about the effect on the surgical repair.

Rehabilitation following rotator cuff repair: A multi-centre pilot & feasibility randomised controlled trial (RaCeR).

OBJECTIVE: To evaluate the feasibility of a multi-centre randomised controlled trial to compare the clinical and cost-effectiveness of early patient-directed rehabilitation versus standard rehabilitation following surgical repair of the rotator cuff of the shoulder. DESIGN: Two-arm, multi-centre pilot and feasibility randomised controlled trial. SETTING: Five National Health Service hospitals in England. PARTICIPANTS: Adults (n = 73) with non-traumatic rotator cuff tears scheduled for repair were recruited and randomly allocated remotely prior to surgery. INTERVENTIONS: Early patient-directed rehabilitation (n = 37); advised to remove their sling as soon as able and move as symptoms allow. Standard rehabilitation (n = 36); sling immobilisation for four weeks. MEASURES: (1) Randomisation of 20% or more eligible patients. (2) Difference in time out of sling of 40% or more between groups. (3) Follow-up greater than 70%. RESULTS: 73/185 (39%) potentially eligible patients were randomised. Twenty participants were withdrawn, 11 due to not receiving rotator cuff repair. The between-group difference in proportions of participants who exceeded the cut-off of 222.6 hours out of the sling was 50% (80% CI = 29%, 72%), with the early patient-directed rehabilitation group reporting greater time out of sling. 52/73 (71%) and 52/53 (98%) participants were followed-up at 12 weeks when withdrawals were included and excluded respectively. Eighteen full-thickness re-tears were reported (early patient-directed rehabilitation = 7, standard rehabilitation = 11). Five serious adverse events were reported. CONCLUSION: A main randomised controlled trial is feasible but would require allocation of participants following surgery to counter the issue of withdrawal due to not receiving surgery.

Stratified versus usual care for the management of primary care patients with sciatica: the SCOPiC RCT.

BACKGROUND: Sciatica has a substantial impact on patients and society. Current care is 'stepped', comprising an initial period of simple measures of advice and analgesia, for most patients, commonly followed by physiotherapy, and then by more intensive interventions if symptoms fail to resolve. No study has yet tested a model of stratified care in which patients are subgrouped and matched to different care pathways based on their prognosis and clinical characteristics. OBJECTIVES: The objectives were to investigate the clinical effectiveness and cost-effectiveness of a stratified care model compared with usual, non-stratified care. DESIGN: This was a two-parallel group, multicentre, pragmatic, 1 : 1 randomised controlled trial. SETTING: Participants were recruited from primary care (42 general practices) in North Staffordshire, North Shropshire/Wales and Cheshire in the UK. PARTICIPANTS: Eligible patients were aged ≥ 18 years, had suspected sciatica, had access to a mobile phone/landline, were not pregnant, were not receiving treatment for the same problem and had not had previous spinal surgery. INTERVENTIONS: In stratified care, a combination of prognostic and clinical criteria associated with referral to spinal specialist services was used to allocate patients to one of three groups for matched care pathways. Group 1 received advice and up to two sessions of physiotherapy, group 2 received up to six sessions of physiotherapy, and group 3 was fast-tracked to magnetic resonance imaging and spinal specialist opinion. Usual care was based on the stepped-care approach without the use of any stratification tools/algorithms. Patients were randomised using a remote web-based randomisation service. MAIN OUTCOME MEASURES: The primary outcome was time to first resolution of sciatica symptoms (six point ordinal scale, collected via text messages). Secondary outcomes (at 4 and 12 months) included pain, function, psychological health, days lost from work, work productivity, satisfaction with care and health-care use. A cost-utility analysis was undertaken over 12 months. A qualitative study explored patients' and clinicians' views of the fast-track care pathway to a spinal specialist. RESULTS: A total of 476 patients were randomised (238 in each arm). For the primary outcome, the overall response rate was 89.3% (88.3% and 90.3% in the stratified and usual care arms, respectively). Relief from symptoms was slightly faster (2 weeks median difference) in the stratified care arm, but this difference was not statistically significant (hazard ratio 1.14, 95% confidence interval 0.89 to 1.46; p = 0.288). On average, participants in both arms reported good improvement from baseline, on most outcomes, over time. Following the assessment at the research clinic, most participants in the usual care arm were referred to physiotherapy. CONCLUSIONS: The stratified care model tested in this trial was not more clinically effective than usual care, and was not likely to be a cost-effective option. The fast-track pathway was felt to be acceptable to both patients and clinicians; however, clinicians expressed reluctance to consider invasive procedures if symptoms were of short duration. LIMITATIONS: Participants in the usual care arm, on average, reported good outcomes, making it challenging to demonstrate superiority of stratified care. The performance of the algorithm used to allocate patients to treatment pathways may have influenced results. FUTURE WORK: Other approaches to stratified care may provide superior outcomes for sciatica. TRIAL REGISTRATION: Current Controlled Trials ISRCTN75449581. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 49. See the NIHR Journals Library website for further project information.

Sciatica is pain that spreads into the leg because of a trapped nerve in the lower back. It can be a very painful condition that affects everyday life and ability to work. People with sciatica usually see their general practitioner first; if they do not get better over time, they may be referred to a physiotherapist or, eventually, to a spinal specialist. It is difficult to know which sciatica patient will do well without much treatment and who might need to see a physiotherapist or spinal specialist sooner. Stratified care is an approach aiming to help decide, early on, which patients need to see which health professionals. It has previously been shown to be helpful for patients with lower-back pain. In a trial of 476 patients with sciatica a stratified care model was tested to see if it led to faster improvements in sciatica-related leg pain, when compared with usual care. Adults seeing their general practitioner with sciatica were invited to attend a research clinic. Those willing to take part were randomly assigned to stratified care or usual care. Patients in the stratified care arm were referred either to physiotherapy for a short or a longer course of treatment, or to undergo magnetic resonance imaging and see a spinal specialist with the magnetic resonance imaging results within 4 weeks. Pain, function and quality-of-life data were collected over 12 months using text messages and questionnaires. Although patients in the stratified care arm improved slightly more quickly (2 weeks, on average), we did not find convincing evidence that stratified care led to better results than usual care. On average, most patients in both trial arms improved in a similar way over 12 months. The stratified care model tested in this trial did not lead to faster recovery for patients with sciatica than usual care.

Stratified care versus usual care for management of patients presenting with sciatica in primary care (SCOPiC): a randomised controlled trial.

BACKGROUND: Sciatica has a substantial impact on individuals and society. Stratified care has been shown to lead to better outcomes among patients with non-specific low back pain, but it has not been tested for sciatica. We aimed to investigate the clinical and cost-effectiveness of stratified care versus non-stratified usual care for patients presenting with sciatica in primary care. METHODS: We did a two-parallel arm, pragmatic, randomised controlled trial across three centres in the UK (North Staffordshire, North Shropshire/Wales, and Cheshire). Eligible patients were aged 18 years or older, had a clinical diagnosis of sciatica, access to a mobile phone or landline number, were not pregnant, were not currently receiving treatment for the same problem, and had no previous spinal surgery. Patients were recruited from general practices and randomly assigned (1:1) by a remote web-based service to stratified care or usual care, stratified by centre and stratification group allocation. In the stratified care arm, a combination of prognostic and clinical criteria associated with referral to spinal specialist services were used to allocate patients to one of three groups for matched care pathways. Group 1 was offered brief advice and support in up to two physiotherapy sessions; group 2 was offered up to six physiotherapy sessions; and group 3 was fast-tracked to MRI and spinal specialist assessment within 4 weeks of randomisation. The primary outcome was self-reported time to first resolution of sciatica symptoms, defined as "completely recovered" or "much better" on a 6-point ordinal scale, collected via text messages or telephone calls. Analyses were by intention to treat. Health-care costs and cost-effectiveness were also assessed. This trial is registered on the ISRCTN registry, ISRCTN75449581. FINDINGS: Between May 28, 2015, and July 18, 2017, 476 patients from 42 general practices around three UK centres were randomly assigned to stratified care or usual care (238 in each arm). For the primary outcome, the overall response rate was 89% (9467 of 10 601 text messages sent; 4688 [88%] of 5310 in the stratified care arm and 4779 [90%] of 5291 in the usual care arm). Median time to symptom resolution was 10 weeks (95% CI 6·4-13·6) in the stratified care arm and 12 weeks (9·4-14·6) in the usual care arm, with the survival analysis showing no significant difference between the arms (hazard ratio 1·14 [95% CI 0·89-1·46]). Stratified care was not cost-effective compared to usual care. INTERPRETATION: The stratified care model for patients with sciatica consulting in primary care was not better than usual care for either clinical or health economic outcomes. These results do not support a transition to this stratified care model for patients with sciatica. FUNDING: National Institute for Health Research.

Defining adherence to therapeutic exercise for musculoskeletal pain: a systematic review.

OBJECTIVE: To establish the meaning of the term 'adherence' (including conceptual and measurement definitions) in the context of therapeutic exercise (TE) for musculoskeletal (MSK) pain. DESIGN: Systematic review using a search strategy including terms for: adherence, TE and MSK pain. Identified studies were independently screened for inclusion by two researchers. Two independent researchers extracted data on: study type; MSK pain population; type of TE used; definitions, parameters, measurement methods and values of adherence. DATA SOURCES: Seven electronic databases were searched from inception to December 2016. ELIGIBILITY CRITERIA: Any study type featuring TE for adults with MSK pain and containing a definition of adherence, or a description of how adherence was measured. RESULTS: 459 studies were identified and 86 were included in the review. Most were prospective cohort studies and featured back and/or neck pain. Strengthening and stretching were the most common types of TE. A clearly identifiable definition of adherence was provided in 40% of the studies, with 12% using the same definition. Exercise frequency was the most commonly measured parameter of adherence, with self-report logs the most common measurement method. The most common value range used to determine satisfactory adherence was 80%-99% of the recommended exercise dose. CONCLUSION: No single definition of adherence to TE was apparent. We found no definition of adherence that specifically related to TE for MSK pain or described the dimensions of TE that should be measured. We recommend conceptualising adherence to TE for MSK pain from the perspective of all relevant stakeholders.

Protocol for a multi-centre pilot and feasibility randomised controlled trial with a nested qualitative study: rehabilitation following rotator cuff repair (the RaCeR study).

BACKGROUND: Shoulder pain is a highly prevalent complaint and disorders of the rotator cuff, including tears, are thought to be the most common cause. The number of operations repair the torn rotator cuff has risen significantly in recent years. While surgical techniques have progressed, becoming less invasive and more secure, rehabilitation programmes have remained largely like those initially developed when surgical techniques were less advanced and more invasive. Uncertainty remains in relation to the length of post-surgical immobilisation and the amount of early load permitted at the repair site. In the context of this uncertainty, current practice is to follow a generally cautious approach, including long periods of immobilisation in a sling and avoidance of early active rehabilitation. Systematic review evidence suggests early mobilisation might be beneficial but further high-quality studies are required to evaluate this. METHODS/DESIGN: RaCeR is a two-arm, multi-centre pilot and feasibility randomised controlled trial with nested qualitative interviews. A total of 76 patients with non-traumatic rotator cuff tears who are scheduled to have a surgical repair will be recruited from up to five UK NHS hospitals and randomly allocated to either early patient-directed rehabilitation or standard rehabilitation that incorporates sling immobilisation. RaCeR will assess the feasibility of a future, substantive, multi-centre randomised controlled trial to test the hypothesis that, compared to standard rehabilitation incorporating sling immobilisation, early patient-directed rehabilitation is both more clinically effective and more cost-effective. In addition, a sample of patients and clinicians will be interviewed to understand the acceptability of the interventions and the barriers and enablers to adherence to the interventions. DISCUSSION: Research to date suggests that there is the possibility of reducing the patient burden associated with post-operative immobilisation following surgery to repair the torn rotator cuff and improve clinical outcomes. There is a clear need for a high-quality, adequately powered, randomised trial to better inform clinical practice. Prior to a large-scale trial, we first need to undertake a pilot and feasibility trial to address current uncertainties about recruitment, retention and barriers to adherence to the interventions, particularly in relation to whether patients will be willing to begin moving their arm early after their operation. TRIAL REGISTRATION: ISRCTN Registry, 18357968 . Registered on 10 August 2018.

Predictors of pain interference and potential gain from intervention in community dwelling adults with joint pain: A prospective cohort study.

INTRODUCTION: There is little research on identifying modifiable risk factors that predict future interference of pain with daily activity in people with joint pain, and the estimation of the corresponding population attributable risk (PAR). The present study therefore investigated modifiable predictors of pain interference and estimated maximum potential gain from intervention in adults with joint pain. METHODS: A population-based cohort aged ≥50 years was recruited from eight general practices in North Staffordshire, UK. Participants (n = 1878) had joint pain at baseline lasting ≥3 months and indicated no pain interference. Adjusted associations of self-reported, potentially modifiable prognostic factors (body mass index, anxiety/depressive symptoms, widespread pain, inadequate joint pain control, physical inactivity, sleep problems, smoking and alcohol intake) with onset of pain interference 3 years later were estimated via Poisson regression, and corresponding PAR estimates were obtained. RESULTS: Inadequate joint-specific pain control, insomnia and infrequent walking were found to be independently significantly associated with the onset of pain interference after 3 years, with associated PARs of 6.3% (95% confidence interval -0.3, 12.4), 7.6% (-0.4, 15.0) and 8.0% (0.1, 15.2), respectively, with only the PAR for infrequent walking deemed statistically significant. The PAR associated with insomnia, infrequent walking and inadequate control of joint pain simultaneously was 20.3% (8.6, 30.4). CONCLUSIONS: There is potential to reduce moderately the onset of pain interference from joint pain in the over-50s if clinical and public health interventions targeted pain management and insomnia, and promoted an active lifestyle. However, most of the onset of significant pain interference in the over-50s, would not be prevented, even assuming that these factors could be eliminated.

Cost-utility analysis of interventions to improve effectiveness of exercise therapy for adults with knee osteoarthritis: the BEEP trial.

OBJECTIVES: Evidence regarding the cost-effectiveness of enhancing physical therapy exercise programmes in order to improve outcomes for patients with knee OA remains unclear. This study investigates the cost-effectiveness of two enhanced physical therapy interventions compared with usual physical therapy care (UC) for adults with knee OA. METHODS: A trial-based cost-utility analysis of individually tailored exercise (ITE) or targeted exercise adherence (TEA) compared with UC was undertaken over a period of 18 months. Patient-level costs were obtained, and effectiveness was measured in terms of quality-adjusted life years (QALYs), allowing the calculation of cost per QALY gained from a base-case UK health-care perspective. RESULTS: The UC group was associated with lower National Health Service (NHS) costs [ITE-UC: £273.30, 95% CI: £-62.10 to £562.60; TEA-UC: £141.80, 95% CI: £-135.60 to £408.10)] and slightly higher QALY gains (ITE-UC: -0.015, 95% CI: -0.057 to 0.026; TEA-UC: -0.003, 95% CI: -0.045 to 0.038). In the base case, UC was the most likely cost-effective option (probability <40% of ITE or TEA cost-effective at £20 000/QALY). Differences in total costs were attributable to intervention costs, number of visits to NHS consultants and knee surgery, which were higher in both ITE and TEA groups. CONCLUSION: This is the first economic evaluation comparing usual physical therapy care vs enhanced exercise interventions for knee OA that involves greater exercise individualization, supervision and progression or that focuses on exercise and physical activity adherence over the longer term. Our findings show that UC is likely to be the most cost-effective option. TRIAL REGISTRATION: Current Controlled Trials ISRCTN 93634563. TRIAL PROTOCOL: Full details of the trial protocol can be found in the Supplementary Appendix, available with the full text of this article at http://www.biomedcentral.com/1471-2474/15/254 doi: 10.1186/1471-2474-15-254.