The role of injections of therapeutic substances into the back as treatment for low back pain is unclear. Facet joint injections are widely used despite the absence of evidence of sustained benefit. We hypothesise that facet joint injections might facilitate engagement with physiotherapist-led, best usual care (a combined physical and psychological programme) and is a clinically and cost-effective treatment for people with suspected low back pain of facet joint origin. We present here the protocol for a randomised controlled feasibility trial for a main trial to test the above hypotheses. Patients referred to secondary care with persistent non-specific low back pain will be screened and invited to take part in the study. Those who meet the eligibility criteria will be invited for a physiotherapy assessment to confirm trial eligibility and for baseline data collection. All participants (n = 150) will be offered the best usual care package with physical and psychological components. Those randomised into the intervention arm (n = 75) will, in addition, receive intra-articular facet joint injections with local anaesthetic and steroids. Primary outcome data will be collected using daily and then weekly text messaging service for a pain score on a 0–10 scale. Questionnaire follow-up will be at 3, 6, and 12 months. Evaluation of trial processes and health economic analyses, including a value of information analysis, will be undertaken. The process evaluation will be mixed methods and will include the views of all stakeholders. Whilst this trial is a feasibility study it is currently one of the largest trials in this area. The outcomes will provide some evidence on the use of facet joint injections for patients with clinically diagnosed facet joint pain. EudraCT identifier 2014-000682-50, (registered on 12 February 14). ISRCTN registry number: ISRCTN93184143 DOI 10.1186/ISRCTN93184143 (registered on 27 February 2014).
Low back pain is a common and disabling condition leading to large health service and societal costs. Although there are several treatment options for back pain little is known about how to improve patient choice in treatment selection. The purpose of this study was to pilot a decision support package to help people choose between low back pain treatments. This was a single-centred pilot cluster randomised controlled trial conducted in a community physiotherapy service. We included adults with non-specific low back pain referred for physiotherapy. Intervention participants were sent an information booklet prior to their first consultation. Intervention physiotherapists were trained to enhance their skills in shared informed decision making. Those in the control arm received care as usual. The primary outcome was satisfaction with the treatment received at four months using a five-point Likert Scale dichotomised into “satisfaction” (very satisfied or somewhat satisfied) and “non-satisfaction” (neither satisfied nor dissatisfied, somewhat dissatisfied or very dissatisfied). We recruited 148 participants. In the control arm 67% of participants were satisfied with their treatment and in the intervention arm 53%. The adjusted relative risk of being satisfied was 1.28 (95% confidence interval 0.79 to 2.09). For most secondary outcomes the trend was towards worse outcomes in the intervention group. For one measure; the Roland Morris Disability Questionnaire, this difference was clinically important (2.27, 95% confidence interval 0.08 to 4.47). Mean healthcare costs were slightly lower (£38 saving per patient) within the intervention arm but health outcomes were also less favourable (0.02 fewer QALYs); the estimated probability that the intervention would be cost-effective at an incremental threshold of £20,000 per QALY was 16%. We did not find that this decision support package improved satisfaction with treatment; it may have had a substantial negative effect on clinical outcome, and is very unlikely to prove cost-effective. That a decision support package might have a clinically important detrimental effect is of concern. To our knowledge this has not been observed previously. Decision support packages should be formally tested for clinical and cost-effectiveness, and safety before implementation. Current Controlled Trials ISRCTN46035546 registered on 11/02/10.
After publication of this protocol a change in study design was needed [1].Due to changes in the service configuration in the host physiotherapy department individual randomisation as originally planned could not be implemented.It was necessary to change to cluster randomisation with the unit of randomisation being the treating physiotherapist.Potential participants are given outpatient appointments by booking staff unaware of the physiotherapist's randomisation.Trial recruitment is also done blind to physiotherapist allocation.In this manner we have ensured allocation concealment prior to participants joining the study.Cluster randomised trials need to inflate their sample size to account for clustering.Typically primary care trials use an intra-cluster correlation coefficient (ICC) of 0.05 in this calculation [2].Our past experience is that clustering effects by therapist in trials of this nature may be very small [3].To account for this we developed a provisional revised sample size using an ICC of 0.05 and did an interim analysis of pooled data, just for ICC of the primary outcome, after the first 40 participants had completed the three month follow-up questionnaire.The ICC was close to zero, suggesting that using an ICC of 0.05 was too conservative.We therefore assumed an ICC of 0.01 to estimate the design effect due to clustering.Based on an average cluster size of nine this results in a revised final sample size of 158.
Background The National Institute for Health and Care Excellence (NICE) 2009 guidelines for persistent low back pain (LBP) do not recommend the injection of therapeutic substances into the back as a treatment for LBP because of the absence of evidence for their effectiveness. This feasibility study aimed to provide a stable platform that could be used to evaluate a randomised controlled trial (RCT) on the clinical effectiveness and cost-effectiveness of intra-articular facet joint injections (FJIs) when added to normal care. Objectives To explore the feasibility of running a RCT to test the hypothesis that, for people with suspected facet joint back pain, adding the option of intra-articular FJIs (local anaesthetic and corticosteroids) to best usual non-invasive care is clinically effective and cost-effective. Design The trial was a mixed design. The RCT pilot protocol development involved literature reviews and a consensus conference followed by a randomised pilot study with an embedded mixed-methods process evaluation. Setting Five NHS acute trusts in England. Participants Participants were patients aged ≥ 18 years with moderately troublesome LBP present (> 6 months), who had failed previous conservative treatment and who had suspected facet joint pain. The study aimed to recruit 150 participants (approximately 30 per site). Participants were randomised sequentially by a remote service to FJIs combined with ‘best usual care’ (BUC) or BUC alone. Interventions All participants were to receive six sessions of a bespoke BUC rehabilitation package. Those randomised into the intervention arm were, in addition, given FJIs with local anaesthetic and steroids (at up to six injection sites). Randomisation occurred at the end of the first BUC session. Main outcome measures Process and clinical outcomes. Clinical outcomes included a measurement of level of pain on a scale from 0 to 10, which was collected daily and then weekly via text messaging (or through a written diary). Questionnaire follow-up was at 3 months. Results Fifty-two stakeholders attended the consensus meeting. Agreement informed several statistical questions and three design considerations: diagnosis, the process of FJI and the BUC package and informing the design for the randomised pilot study. Recruitment started on 26 June 2015 and was terminated by the funder (as a result of poor recruitment) on 11 December 2015. In total, 26 participants were randomised. Process data illuminate some of the reasons for recruitment problems but also show that trial processes after enrolment ran smoothly. No between-group analysis was carried out. All pain-related outcomes show the expected improvement between baseline and follow-up. The mean total cost of the overall treatment package (injection £419.22 and BUC £264.00) was estimated at £683.22 per participant. This is similar to a NHS tariff cost for a course of FJIs of £686.84. Limitations Poor recruitment was a limiting factor. Conclusions This feasibility study achieved consensus on the main challenges in a trial of FJIs for people with persistent non-specific low back pain. Future work Further work is needed to test recruitment from alternative clinical situations. Trial registration EudraCT 2014-000682-50 and Current Controlled Trials ISRCTN93184143. 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. 30. See the NIHR Journals Library website for further project information.
Low back pain is a common and costly condition. There are several treatment options for people suffering from back pain, but there are few data on how to improve patients' treatment choices. This study will test the effects of a decision support package (DSP), designed to help patients seeking care for back pain to make better, more informed choices about their treatment within a physiotherapy department. The package will be designed to assist both therapist and patient. Firstly, in collaboration with physiotherapists, patients and experts in the field of decision support and decision aids, we will develop the DSP. The work will include: a literature and evidence review; secondary analysis of existing qualitative data; exploration of patients' perspectives through focus groups and exploration of experts' perspectives using a nominal group technique and a Delphi study. Secondly, we will carry out a pilot single centre randomised controlled trial within NHS Coventry Community Physiotherapy. We will randomise physiotherapists to receive either training for the DSP or not. We will randomly allocate patients seeking treatment for non specific low back pain to either a physiotherapist trained in decision support or to receive usual care. Our primary outcome measure will be patient satisfaction with treatment at three month follow-up. We will also estimate the cost-effectiveness of the intervention, and assess the value of conducting further research. Informed shared decision-making should be an important part of any clinical consultation, particularly when there are several treatments, which potentially have moderate effects. The results of this pilot will help us determine the benefits of improving the decision-making process in clinical practice on patient satisfaction. Current Controlled Trials ISRCTN46035546
Background There is good evidence that therapist-delivered interventions have modest beneficial effects for people with low back pain (LBP). Identification of subgroups of people with LBP who may benefit from these different treatment approaches is an important research priority. Aim and objectives To improve the clinical effectiveness and cost-effectiveness of LBP treatment by providing patients, their clinical advisors and health-service purchasers with better information about which participants are most likely to benefit from which treatment choices. Our objectives were to synthesise what is already known about the validity, reliability and predictive value of possible treatment moderators (patient factors that predict response to treatment) for therapist-delivered interventions; develop a repository of individual participant data from randomised controlled trials (RCTs) testing therapist-delivered interventions for LBP; determine which participant characteristics, if any, predict clinical response to different treatments for LBP; and determine which participant characteristics, if any, predict the most cost-effective treatments for LBP. Achieving these objectives required substantial methodological work, including the development and evaluation of some novel statistical approaches. This programme of work was not designed to analyse the main effect of interventions and no such interpretations should be made. Methods First, we reviewed the literature on treatment moderators and subgroups. We initially invited investigators of trials of therapist-delivered interventions for LBP with > 179 participants to share their data with us; some further smaller trials that were offered to us were also included. Using these trials we developed a repository of individual participant data of therapist-delivered interventions for LBP. Using this data set we sought to identify which participant characteristics, if any, predict response to different treatments (moderators) for clinical effectiveness and cost-effectiveness outcomes. We undertook an analysis of covariance to identify potential moderators to apply in our main analyses. Subsequently, we developed and applied three methods of subgroup identification: recursive partitioning (interaction trees and subgroup identification based on a differential effect search); adaptive risk group refinement; and an individual participant data indirect network meta-analysis (NWMA) to identify subgroups defined by multiple parameters. Results We included data from 19 RCTs with 9328 participants (mean age 49 years, 57% females). Our prespecified analyses using recursive partitioning and adaptive risk group refinement performed well and allowed us to identify some subgroups. The differences in the effect size in the different subgroups were typically small and unlikely to be clinically meaningful. Increasing baseline severity on the outcome of interest was the strongest driver of subgroup identification that we identified. Additionally, we explored the application of Bayesian indirect NWMA. This method produced varying probabilities that a particular treatment choice would be most likely to be effective for a specific patient profile. Conclusions These data lack clinical effectiveness or cost-effectiveness justification for the use of baseline characteristics in the development of subgroups for back pain. The methodological developments from this work have the potential to be applied in other clinical areas. The pooled repository database will serve as a valuable resource to the LBP research community. Funding The National Institute for Health Research Programme Grants for Applied Research programme. This project benefited from facilities funded through Birmingham Science City Translational Medicine Clinical Research and Infrastructure Trials Platform, with support from Advantage West Midlands (AWM) and the Wolfson Foundation.
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