Transforaminal epidural steroid injection (TFESI) should be considered as a first invasive treatment option, up to 12 months, for patients with sciatica secondary to herniated lumbar disc. This is according to the results of a randomised controlled trial, NERVES, which were presented at the 2021 Eurospine annual meeting (6–8 October, Vienna, Austria) by Martin Wilby (Department of Neurosurgery, The Walton Centre NHS Foundation Trust, Liverpool, UK).
In addition, data from this phase three, multicentre, open-label, RCT and economic evaluation, which were also published in the The Lancet Rheumatology by Wilby et al in May 2021, highlighted that surgery is “unlikely to be a cost-effective alternative to TFESI”.
The NERVES trial aimed to investigate the clinical and cost-effectiveness of non-surgical treatments, such as TFESI, over surgical microdiscectomy for the management of radicular pain secondary to herniated lumbar disc.
Speaking to Spinal News International, Wilby said: “Whilst surgery remains an excellent treatment for this condition and is still the treatment of choice for large discs producing neurological deficit, for the vast majority of disc prolapses which irritate/compress the transiting nerves in the lateral recess without deficit, there may well be a cheaper alternative.
“There is a lot of evidence that the majority of simple disc prolapses heal naturally over time, so the provision of a temporary injection may give patients enough improvement whilst this happens. These injections won’t work for all patients but our data suggests that more than half of patients requiring further treatment on top of medicine analgesia would benefit from them significantly.
“Also, from a healthcare provision perspective, this treatment is safe, quick, cheap and there are many more injection treatment providers in the world than spinal surgeons. The challenge now is to identify these patients as rapidly and safely as possible to get them this treatment sooner than it is currently.”
The trial was conducted at 11 spinal units across the UK and included patients between the ages of 16 and 65. Those eligible had MRI-confirmed non-emergency sciatica secondary to herniated lumbar disc with symptom duration between six weeks and 12 months, and had leg pain that was not responsive to non-invasive management.
Participants were randomly assigned (1:1) to receive either TFESI or surgical microdiscectomy. The primary outcome was Oswestry Disability Questionnaire (ODQ) score at 18 weeks. All randomly assigned participants who completed a valid ODQ at baseline and at 18 weeks were included in the analysis. Safety analysis included all treated participants. Cost-effectiveness was estimated from the EuroQol-5D-5L, Hospital Episode Statistics, medication usage, and self-reported resource-use data.
A total of 163 (15%) of 1,055 screened patients were enrolled between March 2015 and December 2017, with 80 participants (49%) randomly assigned to the TFESI group and 83 participants (51%) to the surgery group.
At week 18, ODQ scores were 30.02 (SD 24.38) for 63 assessed patients in the TFESI group and 22.30 (19.83) for 61 assessed patients in the surgery group. Mean improvement was 24.52 points (18.89) for the TFESI group and 26.74 points (21.35) for the surgery group, with an estimated treatment difference of −4.25 (95% CI −11.09 to 2.59; p=0·22).
There were four serious adverse events in four participants associated with surgery, and none with TFESI. Compared with TFESI, surgery had an incremental cost-effectiveness ratio of £38,737 per quality-adjusted life-year gained, and a 0.17 probability of being cost-effective at a willingness-to-pay threshold of £20,000 per quality-adjusted life-year.