Supporting self-management of low back pain with an internet intervention with and without telephone support in primary care (SupportBack 2): a randomised controlled trial of clinical and cost-effectiveness.

BACKGROUND: Low back pain is prevalent and a leading cause of disability. We aimed to determine the clinical and cost-effectiveness of an accessible, scalable internet intervention for supporting behavioural self-management (SupportBack). METHODS: Participants in UK primary care with low back pain without serious spinal pathology were randomly assigned 1:1:1 using computer algorithms stratified by disability level and telephone-support centre to usual care, usual care and SupportBack, or usual care and SupportBack with physiotherapist telephone-support (three brief calls). The primary outcome was low back pain-related disability (Roland Morris Disability Questionnaire [RMDQ] score) at 6 weeks, 3 months, 6 months, and 12 months using a repeated measures model, analysed by intention to treat using 97·5% CIs. A parallel economic evaluation from a health services perspective was used to estimate cost-effectiveness. People with lived experience of low back pain were involved in this trial from the outset. This completed trial was registered with ISRCTN, ISRCTN14736486. FINDINGS: Between Nov 29, 2018, and Jan 12, 2021, 825 participants were randomly assigned (274 to usual care, 275 to SupportBack only, 276 to SupportBack with telephone-support). Participants had a mean age of 54 (SD 15), 479 (58%) of 821 were women and 342 (42%) were men, and 591 (92%) of 641 were White. Follow-up rates were 687 (83%) at 6 weeks, 598 (73%) at 3 months, 589 (72%) at 6 months, and 652 (79%) at 12 months. For the primary analysis, 736 participants were analysed (249 usual care, 245 SupportBack, and 242 SupportBack with telephone support). At a significance level of 0·025, there was no difference in RMDQ over 12 months with SupportBack versus usual care (adjusted mean difference -0·5 [97·5% CI -1·2 to 0·2]; p=0·085) or SupportBack with telephone-support versus usual care (-0·6 [-1·2 to 0·1]; p=0·048). There were no treatment-related serious adverse events. The economic evaluation showed that the SupportBack group dominated usual care, being both more effective and less costly. Both interventions were likely to be cost-effective at a threshold of £20 000 per quality adjusted life year compared with usual care. INTERPRETATION: The SupportBack internet interventions did not significantly reduce low back pain-related disability over 12 months compared with usual care. They were likely to be cost-effective and safe. Clinical effectiveness, cost-effectiveness, and safety should be considered together when determining whether to apply these interventions in clinical practice. FUNDING: National Institute for Health and Care Research Health Technology Assessment (16/111/78).

The cost-effectiveness of different approaches to exercise and corticosteroid injection for subacromial pain (impingement) syndrome.

OBJECTIVES: To determine whether physiotherapist-led exercise intervention and US-guided subacromial CS injection is cost-effective when compared with standard advice and exercise leaflet and unguided injection in patients with subacromial pain (impingement) syndrome. METHODS: An incremental cost-utility analysis using patient responses to the five-level EuroQoL-5D (EQ-5D-5L) questionnaire was undertaken from a healthcare perspective alongside a 2 × 2 factorial randomized trial with 256 participants over a 12-month follow-up period. Uncertainty was explored through the use of cost-effectiveness acceptability curves. RESULTS: The cost-utility analysis indicated that physiotherapist-led exercise was associated with an incremental cost of £155.99 (95% CI 69.02, 241.93) and 0.031 (95% CI -0.01, 0.07) additional quality-adjusted life-years (QALYs), an incremental cost-effectiveness ratio (ICER) of £5031 per QALY gained and an 85% chance of being cost-effective at a threshold of £20 000 per QALY gained compared with the advice and exercise leaflet. US-guided injection was associated with an incremental cost of £15.89 (95% CI -59.36, 109.86) and 0.024 (95% CI -0.02, 0.07) additional QALYs, an ICER of £662 per QALY gained and a 83% chance of being cost-effective at a threshold of £20 000 per QALY gained compared with unguided injection. CONCLUSION: Physiotherapist-led exercise was cost-effective compared with the advice and exercise leaflet, and US-guided injection was cost-effective when compared with unguided injection. CLINICAL TRIAL REGISTRATION: ISRCTN, http://www.isrctn.com, ISRCTN42399123.

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.

Supporting self-management of low back pain with an internet intervention in primary care: a protocol for a randomised controlled trial of clinical and cost-effectiveness (SupportBack 2).

INTRODUCTION: Self-management and remaining physically active are first-line recommendations for the care of patients with low back pain (LBP). With a lifetime prevalence of up to 85%, novel approaches to support behavioural self-management are needed. Internet interventions may provide accessible support for self-management of LBP in primary care. The aim of this randomised controlled trial is to determine the clinical and cost-effectiveness of the 'SupportBack' internet intervention, with or without physiotherapist telephone support in reducing LBP-related disability in primary care patients. METHODS AND ANALYSIS: A three-parallel arm, multicentre randomised controlled trial will compare three arms: (1) usual primary care for LBP; (2) usual primary care for LBP and an internet intervention; (3) usual primary care for LBP and an internet intervention with additional physiotherapist telephone support. Patients with current LBP and no indicators of serious spinal pathology are identified and invited via general practice list searches and mailouts or opportunistic recruitment following LBP consultations. Participants undergo a secondary screen for possible serious spinal pathology and are then asked to complete baseline measures online after which they are randomised to an intervention arm. Follow-ups occur at 6 weeks, 3, 6 and 12 months. The primary outcome is physical function (using the Roland and Morris Disability Questionnaire) over 12 months (repeated measures design). Secondary outcomes include pain intensity, troublesome days in pain over the last month, pain self-efficacy, catastrophising, kinesophobia, health-related quality of life and cost-related measures for a full health economic analysis. A full mixed-methods process evaluation will be conducted. ETHICS AND DISSEMINATION: This trial has been approved by a National Health Service Research Ethics Committee (REC Ref: 18/SC/0388). Results will be disseminated through peer-reviewed journals, conferences, communication with practices and patient groups. Patient representatives will support the implementation of our full dissemination strategy. TRIAL REGISTRATION NUMBER: ISRCTN14736486.

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.

Computer-Based Stratified Primary Care for Musculoskeletal Consultations Compared With Usual Care: Study Protocol for the STarT MSK Cluster Randomized Controlled Trial.

BACKGROUND: Musculoskeletal (MSK) pain is a major cause of pain and disability. We previously developed a prognostic tool (Start Back Tool) with demonstrated effectiveness in guiding primary care low back pain management by supporting decision making using matched treatments. A logical next step is to determine whether prognostic stratified care has benefits for a broader range of common MSK pain presentations. OBJECTIVE: This study seeks to determine, in patients with 1 of the 5 most common MSK presentations (back, neck, knee, shoulder, and multisite pain), whether stratified care involving the use of the Keele Start MSK Tool to allocate individuals into low-, medium-, and high-risk subgroups, and matching these subgroups to recommended matched clinical management options, is clinical and cost-effective compared with usual nonstratified primary care. METHODS: This is a pragmatic, two-arm parallel (stratified vs nonstratified care), cluster randomized controlled trial, with a health economic analysis and mixed methods process evaluation. The setting is UK primary care, involving 24 average-sized general practices randomized (stratified by practice size) in a 1:1 ratio (12 per arm) with blinding of trial statistician and outcome data collectors. Randomization units are general practices, and units of observation are adult MSK consulters without indicators of serious pathologies, urgent medical needs, or vulnerabilities. Potential participant records are tagged and individuals invited using a general practitioner (GP) point-of-consultation electronic medical record (EMR) template. The intervention is supported by an EMR template (computer-based) housing the Keele Start MSK Tool (to stratify into prognostic subgroups) and the recommended matched treatment options. The primary outcome using intention-to-treat analysis is pain intensity, measured monthly over 6 months. Secondary outcomes include physical function and quality of life, and an anonymized EMR audit to capture clinician decision making. The economic evaluation is focused on the estimation of incremental quality-adjusted life years and MSK pain-related health care costs. The process evaluation is exploring a range of potential factors influencing the intervention and understanding how it is perceived by patients and clinicians, with quantitative analyses focusing on a priori hypothesized intervention targets and qualitative approaches using focus groups and interviews. The target sample size is 1200 patients from 24 general practices, with >5000 MSK consultations available for anonymized medical record data comparisons. RESULTS: Trial recruitment commenced on May 18, 2018, and ended on July 15, 2019, after a 14-month recruitment period in 24 GP practices. Follow-up and interview data collection was completed in February 2020. CONCLUSIONS: This trial is the first attempt, as far as we know, at testing a prognostic stratified care approach for primary care patients with MSK pain. The results of this trial should be available by the summer of 2020. TRIAL REGISTRATION: ISRCTN Registry ISRCTN15366334; http://www.isrctn.com/ISRCTN15366334. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/17939.

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.

The clinical and cost-effectiveness of corticosteroid injection versus night splints for carpal tunnel syndrome (INSTINCTS trial): an open-label, parallel group, randomised controlled trial.

BACKGROUND: To our knowledge, the comparative effectiveness of commonly used conservative treatments for carpal tunnel syndrome has not been evaluated previously in primary care. We aimed to compare the clinical and cost-effectiveness of night splints with a corticosteroid injection with regards to reducing symptoms and improving hand function in patients with mild or moderate carpal tunnel syndrome. METHODS: We did this randomised, open-label, pragmatic trial in adults (≥18 years) with mild or moderate carpal tunnel syndrome recruited from 25 primary and community musculoskeletal clinics and services. Patients with a new episode of idiopathic mild or moderate carpal tunnel syndrome of at least 6 weeks' duration were eligible. We randomly assigned (1:1) patients (permutated blocks of two and four by site) with an online web or third party telephone service to receive either a single injection of 20 mg methylprednisolone acetate (from 40 mg/mL) or a night-resting splint to be worn for 6 weeks. Patients and clinicians could not be masked to the intervention. The primary outcome was the overall score of the Boston Carpal Tunnel Questionnaire (BCTQ) at 6 weeks. We used intention-to-treat analysis, with multiple imputation for missing data, which was concealed to treatment group allocation. The trial is registered with the European Clinical Trials Database, number 2013-001435-48, and ClinicalTrial.gov, number NCT02038452. FINDINGS: Between April 17, 2014, and Dec 31, 2016, 234 participants were randomly assigned (118 to the night splint group and 116 to the corticosteroid injection group), of whom 212 (91%) completed the BCTQ at 6 weeks. The BCTQ score was significantly better at 6 weeks in the corticosteroid injection group (mean 2·02 [SD 0·81]) than the night splint group (2·29 [0·75]; adjusted mean difference -0·32; 95% CI -0·48 to -0·16; p=0·0001). No adverse events were reported. INTERPRETATION: A single corticosteroid injection shows superior clinical effectiveness at 6 weeks compared with night-resting splints, making it the treatment of choice for rapid symptom response in mild or moderate carpal tunnel syndrome presenting in primary care. FUNDING: Arthritis Research UK.

Lessons learnt from a discontinued randomised controlled trial: adalimumab injection compared with placebo for patients receiving physiotherapy treatment for sciatica (Subcutaneous Injection of Adalimumab Trial compared with Control: SCIATiC).

BACKGROUND: Adalimumab, a biological treatment targeting tumour necrosis factor α, might be useful in sciatica. This paper describes the challenges faced when developing a new treatment pathway for a randomised controlled trial of adalimumab for people with sciatica, as well as the reasons why the trial discussed was stopped early. METHODS: A pragmatic, parallel group, randomised controlled trial with blinded (masked) participants, clinicians, outcome assessment and statistical analysis was conducted in six UK sites. Participants were identified and recruited from general practices, musculoskeletal services and outpatient physiotherapy clinics. They were adults with persistent symptoms of sciatica of 1 to 6 months' duration with moderate to high level of disability. Eligibility was assessed by research physiotherapists according to clinical criteria, and participants were randomised to receive two doses of adalimumab (80 mg then 40 mg 2 weeks later) or saline placebo subcutaneous injections in the posterior lateral thigh. Both groups were referred for a course of physiotherapy. Outcomes were measured at baseline, 6-week, 6-month and 12-month follow-up. The main outcome measure was disability measured using the Oswestry Disability Index. The planned sample size was 332, with the first 50 in an internal pilot phase. RESULTS: The internal pilot phase was discontinued after 10 months from opening owing to low recruitment (two of the six sites active, eight participants recruited). There were several challenges: contractual delays; one site did not complete contract negotiations, and two sites signed contracts shortly before trial closure; site withdrawal owing to patient safety concerns; difficulties obtaining excess treatment costs; and in the two sites that did recruit, recruitment was slower than planned because of operational issues and low uptake by potential participants. CONCLUSIONS: Improved patient care requires robust clinical research within contexts in which treatments can realistically be provided. Step changes in treatment, such as the introduction of biologic treatments for severe sciatica, raise complex issues that can delay trial initiation and retard recruitment. Additional preparatory work might be required before testing novel treatments. A randomised controlled trial of tumour necrosis factor-α blockade is still needed to determine its cost-effectiveness in severe sciatica. TRIAL REGISTRATION: Current Controlled Trials, ISRCTN14569274 . Registered on 15 December 2014.

Cost-Utility Analysis of Routine Anxiety and Depression Screening in Patients Consulting for Osteoarthritis: Results From a Clinical, Randomized Controlled Trial.

OBJECTIVE: To investigate the cost-effectiveness (cost-utility) of introducing general practitioner screening for anxiety and depression in patients consulting for osteoarthritis (OA). METHODS: A cluster-randomized trial-based economic evaluation to assess general practitioners screening for anxiety and depression symptoms in patients consulting for OA compared to usual care (screening for pain intensity) was undertaken over a 12-month period from a UK National Health Service and societal perspective. Patient-level mean costs and mean quality-adjusted life years (QALYs) were estimated, and cost-effectiveness acceptability curves controlling for cluster-level data were constructed. The base-case analysis used the net benefit regressions approach. The 2-stage nonparametric sampling technique was explored in a sensitivity analysis. RESULTS: The base-case analysis demonstrated that the intervention was as costly as, and less effective than, the control (QALY differential -0.029 [95% confidence interval -0.062, 0.003]). In the base-case analyses, general practitioner screening for anxiety and depression was unlikely to be a cost-effective option (probability <5% at £20,000/QALY). Similar results were observed in all sensitivity analyses. CONCLUSION: Prompting general practitioners to routinely screen and manage comorbid anxiety and depression in patients presenting with OA is unlikely to be cost-effective. Further research is needed to explore clinically effective and cost-effective models of managing anxiety and depression in patients presenting with clinical OA.

Cost-effectiveness of a model consultation to support self-management in patients with osteoarthritis.

Objectives: The aim of this study was to estimate the cost-effectiveness of a model OA consultation for OA to support self-management compared with usual care. Methods: An incremental cost-utility analysis using patient responses to the three-level EuroQoL-5D (EQ-5D) questionnaire was undertaken from a UK National Health Service perspective alongside a two-arm cluster-randomized controlled trial. Uncertainty was explored through the use of cost-effectiveness acceptability curves. Results: Differences in health outcomes between the model OA consultation and usual care arms were not statistically significant. On average, visits to the orthopaedic surgeon were lower in the model OA consultation arm by -0.28 (95% CI: -0.55, -0.06). The cost-utility analysis indicated that the model OA consultation was associated with a non-significant incremental cost of £-13.11 (95% CI: -81.09 to 54.85) and an incremental quality adjusted life year (QALY) of -0.003 (95% CI: -0.03 to 0.02), with a 44% chance of being cost-effective at a threshold of £20 000 per QALY gained. The percentage of participants who took time off and the associated productivity cost were lower in the model OA consultation arm. Conclusion: Implementing National Institute for Health and Care Excellence guidelines using a model OA consultation in primary care does not appear to lead to increased costs, but health outcomes remain very similar to usual care. Even though the intervention seems to reduce the demand for orthopaedic surgery, overall it is unlikely to be cost-effective.

Effectiveness and costs of a vocational advice service to improve work outcomes in patients with musculoskeletal pain in primary care: a cluster randomised trial (SWAP trial ISRCTN 52269669).

Musculoskeletal pain is a common cause of work absence, and early intervention is advocated to prevent the adverse health and economic consequences of longer-term absence. This cluster randomised controlled trial investigated the effect of introducing a vocational advice service into primary care to provide occupational support. Six general practices were randomised; patients were eligible if they were consulting their general practitioner with musculoskeletal pain and were employed and struggling at work or absent from work <6 months. Practices in the intervention arm could refer patients to a vocational advisor embedded within the practice providing a case-managed stepwise intervention addressing obstacles to working. The primary outcome was number of days off work, over 4 months. Participants in the intervention arm (n = 158) had fewer days work absence compared with the control arm (n = 180) (mean 9.3 [SD 21·7] vs 14·4 [SD 27·7]) days, incidence rate ratio 0·51 (95% confidence interval 0·26, 0·99), P = 0·048). The net societal benefit of the intervention compared with best care was £733: £748 gain (work absence) vs £15 loss (health care costs). The addition of a vocational advice service to best current primary care for patients consulting with musculoskeletal pain led to reduced absence and cost savings for society. If a similar early intervention to the one tested in this trial was implemented widely, it could potentially reduce days absent over 12 months by 16%, equating to an overall societal cost saving of approximately £500 million (US $6 billion) and requiring an investment of only £10 million.

Subcutaneous Injection of Adalimumab Trial compared with Control (SCIATiC): a randomised controlled trial of adalimumab injection compared with placebo for patients receiving physiotherapy treatment for sciatica.

BACKGROUND: Biological treatments such as adalimumab (Humira®; AbbVie Ltd, Maidenhead, UK) are antibodies targeting tumour necrosis factor alpha, released from ruptured intervertebral discs, which might be useful in sciatica. Recent systematic reviews concluded that they might be effective, but that a definitive randomised controlled trial was needed. Usual care in the NHS typically includes a physiotherapy intervention. OBJECTIVES: To test whether or not injections of adalimumab plus physiotherapy are more clinically effective and cost-effective than injections of saline plus physiotherapy for patients with sciatica. DESIGN: Pragmatic, parallel-group, randomised controlled trial with blinded participants and clinicians, and an outcome assessment and statistical analysis with concurrent economic evaluation and internal pilot. SETTING: Participants were referred from primary care and musculoskeletal services to outpatient physiotherapy clinics. PARTICIPANTS: Adults with persistent symptoms of sciatica of 1-6 months' duration and with moderate to high levels of disability. Eligibility was assessed by research physiotherapists according to clinical criteria for diagnosing sciatica. INTERVENTIONS: After a second eligibility check, trial participants were randomised to receive two doses of adalimumab (80 mg and then 40 mg 2 weeks later) or saline injections. Both groups were referred for a course of physiotherapy. MAIN OUTCOME MEASURES: Outcomes were measured at the start, and after 6 weeks' and 6 months' follow-up. The main outcome measure was the Oswestry Disability Index (ODI). Other outcomes: leg pain version of the Roland-Morris Disability Questionnaire, Sciatica Bothersomeness Index, EuroQol-5 Dimensions, 5-level version, Hospital Anxiety and Depression Scale, resource use, risk of persistent disabling pain, pain trajectory based on a single question, Pain Self-Efficacy Questionnaire, Tampa Scale of Kinesiophobia and adverse effects. SAMPLE SIZE: To detect an effect size of 0.4 with 90% power, a 5% significance level for a two-tailed t-test and 80% retention rate, 332 participants would have needed to be recruited. ANALYSIS PLAN: The primary effectiveness analysis would have been linear mixed models for repeated measures to measure the effects of time and group allocation. An internal pilot study would have involved the first 50 participants recruited across all centres. The primary economic analysis would have been a cost-utility analysis. RESULTS: The internal pilot study was discontinued as a result of low recruitment after eight participants were recruited from two out of six sites. One site withdrew from the study before recruitment started, one site did not complete contract negotiations and two sites signed contracts shortly before trial closure. In the two sites that did recruit participants, recruitment was slow. This was partly because of operational issues, but also because of a low rate of uptake from potential participants. LIMITATIONS: Although large numbers of invitations were sent to potential participants, identified by retrospective searches of general practitioner (GP) records, there was a low rate of uptake. Two sites planned to recruit participants during GP consultations but opened too late to recruit any participants. CONCLUSION: The main failure was attributable to problems with contracts. Because of this we were not able to complete the internal pilot or to test all of the different methods for primary care recruitment we had planned. A trial of biological therapy in patients with sciatica still needs to be done, but would require a clearer contracting process, qualitative research to ensure that patients would be willing to participate, and simpler recruitment methods. TRIAL REGISTRATION: Current Controlled Trials ISRCTN14569274. 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. 21, No. 60. See the NIHR Journals Library website for further project information.

The clinical and cost-effectiveness of stratified care for patients with sciatica: the SCOPiC randomised controlled trial protocol (ISRCTN75449581).

BACKGROUND: Sciatica has a substantial impact on patients, and is associated with high healthcare and societal costs. Although there is variation in the clinical management of sciatica, the current model of care usually involves an initial period of 'wait and see' for most patients, with simple measures of advice and analgesia, followed by conservative and/or more invasive interventions if symptoms fail to resolve. A model of care is needed that does not over-treat those with a good prognosis yet identifies patients who do need more intensive treatment to help with symptoms, and return to everyday function including work. The aim of the SCOPiC trial (SCiatica Outcomes in Primary Care) is to establish whether stratified care based on subgrouping using a combination of prognostic and clinical information, with matched care pathways, is more effective than non-stratified care, for improving time to symptom resolution in patients consulting with sciatica in primary care. We will also assess the impact of stratified care on service delivery and evaluate its cost-effectiveness compared to non-stratified care. METHODS/DESIGN: Multicentre, pragmatic, parallel arm randomised trial, with internal pilot, cost-effectiveness analysis and embedded qualitative study. We will recruit 470 adult patients with sciatica from general practices in England and Wales, over 24 months. Patients will be randomised to stratified care or non-stratified care, and treated in physiotherapy and spinal specialist services, in participating NHS services. The primary outcome is time to first resolution of sciatica symptoms, measured on a 6-point ordered categorical scale, collected using text messaging. Secondary outcomes include physical function, pain intensity, quality of life, work loss, healthcare use and satisfaction with treatment, and will be collected using postal questionnaires at 4 and 12-month follow-up. Semi-structured qualitative interviews with a subsample of participants and clinicians will explore the acceptability of stratified care. DISCUSSION: This paper presents the details of the rationale, design and processes of the SCOPiC trial. Results from this trial will contribute to the evidence base for management of patients with sciatica consulting in primary care. TRIAL REGISTRATION: ISRCTN75449581 , date: 20.11.2014.

STEMS pilot trial: a pilot cluster randomised controlled trial to investigate the addition of patient direct access to physiotherapy to usual GP-led primary care for adults with musculoskeletal pain.

INTRODUCTION: Around 17% of general practitioner (GP) consultations are for musculoskeletal conditions, which will rise as the population ages. Patient direct access to physiotherapy provides one solution, yet adoption in the National Health Service (NHS) has been slow. SETTING: A pilot, pragmatic, non-inferiority, cluster randomised controlled trial (RCT) in general practice and physiotherapy services in the UK. OBJECTIVES: Investigate feasibility of a main RCT. PARTICIPANTS: Adult patients registered in participating practices and consulting with a musculoskeletal problem. INTERVENTIONS: 4 general practices (clusters) randomised to provide GP-led care as usual or the addition of a patient direct access to physiotherapy pathway. OUTCOMES: Process outcomes and exploratory analyses of clinical and cost outcomes. DATA COLLECTION: Participant-level data were collected via questionnaires at identification, 2, 6 and 12 months and through medical records. BLINDING: The study statistician and research nurses were blinded to practice allocation. RESULTS: Of 2696 patients invited to complete study questionnaires, 978 participated (intervention group n=425, control arm n=553) and were analysed. Participant recruitment was completed in 6 months. Follow-up rates were 78% (6 months) and 71% (12 months). No evidence of selection bias was observed. The direct access pathway was used by 90% of patients in intervention practices needing physiotherapy. Some increase in referrals to physiotherapy occurred from one practice, although waiting times for physiotherapy did not increase (28 days before, 26 days after introduction of direct access). No safety issues were identified. Clinical and cost outcomes were similar in both groups. Exploratory estimates of between group effect (using 36-item Short Form Health Survey (SF-36) Physical Component Summary (PCS)) at 6 months was -0.28 (95% CI -1.35 to 0.79) and at 12 months 0.12 (95% CI -1.27 to 1.51). CONCLUSIONS: A full RCT is feasible and will provide trial evidence about the clinical and cost-effectiveness of patient direct access to physiotherapy. TRIAL REGISTRATION NUMBER: ISRCTN23378642.

The clinical and cost effectiveness of steroid injection compared with night splints for carpal tunnel syndrome: the INSTINCTS randomised clinical trial study protocol.

BACKGROUND: Patients diagnosed with idiopathic mild to moderate carpal tunnel syndrome (CTS) are usually managed in primary care and commonly treated with night splints and/or corticosteroid injection. The comparative effectiveness of these interventions has not been reliably established nor investigated in the medium and long term. The primary objective of this trial is to investigate whether corticosteroid injection is effective in reducing symptoms and improving hand function in mild to moderate CTS over 6 weeks when compared with night splints. Secondary objectives are to determine specified comparative clinical outcomes and cost effectiveness of corticosteroid injection over 6 and 24 months. METHOD/DESIGN: A multicentre, randomised, parallel group, clinical pragmatic trial will recruit 240 adults aged ≥18 years with mild to moderate CTS from GP Practices and Primary-Secondary Care Musculoskeletal Interface Clinics. Diagnosis will be by standardised clinical assessment. Participants will be randomised on an equal basis to receive either one injection of 20 mg Depo-Medrone or a night splint to be worn for 6 weeks. The primary outcome is the overall score of the Boston Carpal Tunnel Questionnaire (BCTQ) at 6 weeks. Secondary outcomes are the BCTQ symptom severity and function status subscales, symptom intensity, interrupted sleep, adherence to splinting, perceived benefit and satisfaction with treatment, work absence and reduction in work performance, EQ-5D-5L, referral to surgery and health utilisation costs. Participants will be assessed at baseline and followed up at 6 weeks, 6, 12 and 24 months. The primary analysis will use an intention to treat (ITT) approach and multiple imputation for missing data. The sample size was calculated to detect a 15 % greater improvement in the BTCQ overall score in the injection group compared to night-splinting at approximately 90 % power, 5 % two-tailed significance and allows for 15 % loss to follow-up. DISCUSSION: The trial makes an important contribution to the evidence base available to support effective conservative management of CTS in primary care. No previous trials have directly compared these treatments for CTS in primary care populations, reported on clinical effectiveness at more than 6 months nor compared cost effectiveness of the interventions. TRIAL REGISTRATION: Trial registration: EudraCT 2013-001435-48 (registered 05/06/2013), ClinicalTrials.gov NCT02038452 (registered 16/1/2014), and Current Controlled Trials ISRCTN09392969 (retrospectively registered 01/05/2014).

Reconsultation, self-reported health status and costs following treatment at a musculoskeletal Clinical Assessment and Treatment Service (CATS): a 12-month prospective cohort study.

OBJECTIVES: To determine (1) reconsultation frequency, (2) change in self-reported health status, (3) baseline factors associated with reconsultation and change in health status and (4) associated healthcare costs and quality-adjusted life-years (QALYs), following assessment at a musculoskeletal Clinical and Assessment Treatment Service (CATS). DESIGN: Prospective cohort study. SETTING: Single musculoskeletal CATS at the primary-secondary care interface. PARTICIPANTS: 2166 CATS attenders followed-up by postal questionnaires at 6 and 12 months and review of medical records. OUTCOME MEASURES: Primary outcome was consultation in primary care with the same musculoskeletal problem within 12 months. Secondary outcome measures were consultation at the CATS with the same musculoskeletal problem within 12 months, physical function and pain (Short Form-36), anxiety and depression (Hospital Anxiety and Depression Scale), time off work, healthcare costs and QALYs. RESULTS: Over 12 months, 507 (38%) reconsulted for the same problem in primary care and 345 (26%) at the CATS. Primary care reconsultation in the first 3 months was associated with baseline pain interference (relative risk ratio 5.33; 95% CI 3.23 to 8.80) and spinal pain (1.75; 1.09 to 2.82), and after 3-6 months with baseline assessment by a hospital specialist (2.06; 1.13 to 3.75). Small mean improvements were seen in physical function (1.88; 95% CI 1.44 to 2.32) and body pain (3.86; 3.38 to 4.34) at 6 months. Poor physical function at 6 months was associated with obesity, chronic pain and poor baseline physical function. Mean (SD) 6-month cost and QALYs per patient were £422.40 (660.11) and 0.257 (0.144), respectively. CONCLUSIONS: While most patients are appropriate for a 'one-stop shop' model, those with troublesome, disabling pain and spinal pain commonly reconsult and have ongoing problems. Services should be configured to identify and address such clinical complexity.

An Economic Evaluation of TENS in Addition to Usual Primary Care Management for the Treatment of Tennis Elbow: Results from the TATE Randomized Controlled Trial.

BACKGROUND: The TATE trial was a multicentre pragmatic randomized controlled trial of supplementing primary care management (PCM)-consisting of a GP consultation followed by information and advice on exercises-with transcutaneous electrical nerve stimulation (TENS), to reduce pain intensity in patients with tennis elbow. This paper reports the health economic evaluation. METHODS AND FINDINGS: Adults with new diagnosis of tennis elbow were recruited from 38 general practices in the UK, and randomly allocated to PCM (n = 120) or PCM plus TENS (n = 121). Outcomes included reduction in pain intensity and quality-adjusted-life-years (QALYs) based on the EQ5D and SF6D. Two economic perspectives were evaluated: (i) healthcare-inclusive of NHS and private health costs for the tennis elbow; (ii) societal-healthcare costs plus productivity losses through work absenteeism. Mean outcome and cost differences between the groups were evaluated using a multiple imputed dataset as the base case evaluation, with uncertainty represented in cost-effectiveness planes and through probabilistic cost-effectiveness acceptability curves). Incremental healthcare cost was £33 (95%CI -40, 106) and societal cost £65 (95%CI -307, 176) for PCM plus TENS. Mean differences in outcome were: 0.11 (95%CI -0.13, 0.35) for change in pain (0-10 pain scale); -0.015 (95%CI -0.058, 0.029) for QALYEQ5D; 0.007 (95%CI -0.022, 0.035) for QALYSF6D (higher score differences denote greater benefit for PCM plus TENS). The ICER (incremental cost effectiveness ratio) for the main evaluation of mean difference in societal cost (£) relative to mean difference in pain outcome was -582 (95%CI -8666, 8113). However, incremental ICERs show differences in cost-effectiveness of additional TENS, according to the outcome being evaluated. CONCLUSION: Our findings do not provide evidence for or against the cost-effectiveness of TENS as an adjunct to primary care management of tennis elbow.

Exploring how pain leads to productivity loss in primary care consulters for osteoarthritis: a prospective cohort study.

OBJECTIVE: Osteoarthritis pain has become a leading cause of decreased productivity and work disability in older workers, a major concern in primary care. How osteoarthritis pain leads to decreased productivity at work is unclear; the aim of this study was to elucidate causal mechanisms and thus identify potential opportunities for intervention. METHODS: Population-based prospective cohort study of primary care consulters with osteoarthritis. Path analysis was used to test proposed mechanisms by examining the association between pain at baseline, and onset of work productivity loss at three years for mediation by physical limitation, depression, poor sleep and poor coping mechanisms. RESULTS: High pain intensity was associated with onset of work productivity loss (Adjusted Odds Ratio 2.5; 95%CI 1.3, 4.8). About half of the effect of pain on work productivity was a direct effect, and half was mediated by the impact of pain on physical function. Depression, poor sleep quality and poor coping did not mediate the association between high pain intensity and onset of work productivity loss. CONCLUSIONS: As pain is a major cause of work productivity loss, results suggest that decreasing pain should be a major focus. However, successfully improving function may have an indirect effect by decreasing the impact of pain on work productivity, especially important as significant pain reduction is often difficult to achieve. Although depression, sleep problems, and coping strategies may be directly related to work productivity loss, addressing these issues may not have much effect on the significant impact of pain on work productivity.