Facet joint injections for people with persistent non-specific low back pain (Facet Injection Study): a feasibility study for a randomised controlled trial

Abstract

BackgroundThe 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.ObjectivesTo 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.DesignThe 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.SettingFive NHS acute trusts in England.ParticipantsParticipants 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.InterventionsAll 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 measuresProcess 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.ResultsFifty-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.LimitationsPoor recruitment was a limiting factor.ConclusionsThis feasibility study achieved consensus on the main challenges in a trial of FJIs for people with persistent non-specific low back pain.Future workFurther work is needed to test recruitment from alternative clinical situations.Trial registrationEudraCT 2014-000682-50 and Current Controlled Trials ISRCTN93184143.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 21, No. 30. See the NIHR Journals Library website for further project information.

A quasi-randomised, controlled, feasibility trial of GLITtER (Green Light Imaging Interpretation to Enhance Recovery)—a psychoeducational intervention for adults with low back pain attending secondary care

“…While we did calculate an estimated sample size required for a RCT to definitively examine the effect of the GLITtER intervention, this result should be interpreted with caution. Encouragingly, the baseline value for the pain NRS score and the standard deviation of this measure at 3-month follow-up, were very similar to the data recorded in another LBP feasibility trial on which a sample size estimate was also based ( Ellard et al, 2017 ). Based on the assumption that two participants from each SAC would meet final eligibility criteria for inclusion in the study and be randomised, and that clinics operate on 46 weeks of the year—it appears realistic that 92 participants could be recruited annually.…”

Cryopreserved amniotic membrane and umbilical cord particulate for managing pain caused by facet joint syndrome

“…[ 1 , 2 , 6 ] Between 1994 and 2001, facet joint injections increased by 231% among Medicare patients. [ 7 , 8 ] Widespread use of steroids continues despite variable clinical effectiveness and associated complications such as weight gain, hypertension, osteoporosis, insomnia, and psychosis. [ 7 – 11 ] Thus, there remains unmet clinical need for a safer and more effective treatment for facet joint syndrome.…”

The American Society of Pain and Neuroscience (ASPN) Evidence-Based Clinical Guideline of Interventional Treatments for Low Back Pain

“…However, autologous PRP is a superior treatment option for longer duration efficacy. Ellard et al 444 RCT 26 VAS No analysis due to difficulty in recruitment Sae-Jung et al 72 RCT 99 ODI, VAS This prospective randomized trial is to determine the effectiveness of treating lumbar facet syndrome with oral diclofenac, methylprednisolone facet joint injection or both. The combined treatment was more effective in reducing lumbar facet pain and improving the functional index than either treatment alone.…”