Title: Multi-centre randomised control trial comparing the clinical and cost effectiveness of trans-foraminal epidural steroid injection to surgical microdiscectomy for the treatment of chronic radicular pain secondary to prolapsed intervertebral disc herniation(NErve Rootblock VErsus Surgery:NERVES)
Funder: Department of Health and Social Care

Abstract: Can local anaesthetic and steroid solution administered accurately to the source of radicular leg pain provide a faster, cheaper and more effective treatment for persistent sciatica than an invasive surgical procedure (microdiscectomy) with a proven positive track-record? Sciatica is broadly defined as leg pain in the distribution of a lumbosacral nerve root. Estimates of caseload vary substantially within the literature due to difficulties in definition and poor data capture. A UK epidemiological study suggests lifetime prevalence up to 43%, annual incidence of 5% and point prevalence up to 13% of the population at any one time. Other studies suggest a lifetime prevalence of low back pain over 80%, and that 10% of patients with back pain suffer sciatica as well. Over 90% of sciatica is due to a prolapsed intervertebral disc. In the majority of cases, those affected are young, working adults. It may be helpful to consider three groups of patients; 1. patients may have acute sciatica which lasts less than 6 weeks and may be self-limiting with little or no impact on the patient's work, 2. patients may have resistant sciatica which persists beyond 6 weeks and has a tremendous impact upon the patient's working ability and 3. patients with sciatica for more than 12 months (chronic sciatica). Although studies have shown that most cases of sciatica resolve spontaneously within a year, 30% of patients still experience persistent troublesome symptoms after this and 20% are out of work. Of patients with severe sciatica, days lost from work can be as high as 15 per calendar month. Based on a Dutch study which indicated that the cost of sciatica to society represents 13% of all back-pain related costs, the annual impact on the UK economy is £286m in direct medical costs, and £1.9bn in indirect costs (inflated from 1998 figures). The group of patients we are specifically targeting in this trial are those with persistent sciatica greater than 6 weeks duration but less than six months duration. It is likely that patients will benefit from timely access to treatment and a speedy return to work, although the most clinically and cost effective intervention is unknown. Epidural steroid and anaesthetic injections (ESI) are known to improve patients’ sciatica. A wide variety in practice exists across the UK in methods of administration of the ESI. The most common route of administration of ESI is just off the mid-line between the two laminae. X-ray guidance is not always used to confirm where the injection is given in relation to the pain level (there are 5 lumbar disc levels). Placing the needle through the bony tunnel through which the lumbar nerve root exits the spine can accurately place the drug closer to the target site (Trans-foraminal ESI; TFESI). This routinely requires X-ray guidance. Unfortunately, no evidence exists comparing steroid injections given via the nerve foramen to any other form of treatment. Neither has a robust economic analysis been performed for this condition and these treatment paradigms. The technologies to be compared are 1. Fluoroscopically guided trans-foraminal epidural steroid injection (TFESI) of a standard combination of local anaesthetic and steroid drug and 2. standard surgical lumbar microdiscectomy. We will recruit 150 patients (over multiple sites across the UK) with newly diagnosed but resistant sciatica (greater than 6 weeks duration) who will be followed up for a minimum of 1 year. We will compare trans-foraminal ESI to surgical resection of the prolapsed disc. The primary outcome will be the Oswestry Disability Questionnaire (ODQ; a condition specific outcome measure with over 30 years of scientific validation) at 3 months follow up. Secondary outcomes include ODQ at 6,9 and 12 months, visual analogue pain scores for leg and back pain, Likert scale, Modified Roland-Morris outcome scale for sciatica, Core Outcome Measures Index (COMI), work status, quality of life and health economic outcomes. The team of applicants is multidisciplinary and has a track record for delivering multicentre trials.

Lay abstract: Your spine (backbone) is made up of several bones called vertebrae separated by cushion-like discs. If these discs become damaged the jelly-like substance from the middle of the disc can bulge out through the outer wall. We often call this a ‘slipped’ disc. The damaged disc displaces and inflames the nearby nerves at the base of the spine, and this process can cause severe pain in the back and down one or both legs. This pain is called sciatica. Over 90% of sciatica is caused by an injured disc and the nerve swelling it causes. Patients affected are typically young, working adults. Although the duration of the pain may vary considerably, many patients have pain that persists beyond 6 weeks and could have considerable impact upon patient's lives and employment. The vast majority of sciatica gets better on its own. However, when the sciatic pain is particularly bothersome and lasts more than 6 weeks without settling there are two types of treatment currently offered: · Surgical microdiscectomy · Transforaminal epidural steroid injection (TFESI) These two treatments work in different ways to help reduce pain and are offered to patients who have had other types of treatment, like pain killers, but who are still experiencing pain. In the NERVES study we want to find out if one treatment works better than the other and to do this we are inviting patients who meet our criteria to take part. Across the UK we will be recruiting around 150 patients. Both treatments that will be used in the NERVES study have been shown to improve symptoms. However, this cannot be guaranteed. We hope that information from this study may help doctors and patients in the future when choosing treatment for sciatica. The treatments used in the study are the same as the treatments offered in standard care so there are no extra risks as a result of participating. Like many drugs used in hospitals the steroid injection is not actually licenced for back injections but we are using it in this study because it is standard NHS treatment and research suggests it can work. Both treatments, surgery and injection, are considered to be low-risk as the majority of patients will not have any complications. Surgery is performed under general anaesthetic and patients are admitted to hospital for 24-48 hours to have treatment. During surgery a small cut, usually about 1.5 inches/ 3-4 cm long, is made to allow the surgeon access to the prolapsed disc. The surgeon will try to remove the disc prolapse to take pressure off the nerve and relieve symptoms. The surgeon will use an X-ray machine or CT guidance and a microscope to make sure the incision is as small as possible so the number of stitches will be kept to a minimum. This is part of normal, standard care. Risks of surgery can include bleeding, infection, nerve injury, spinal fluid leak and complications from the general anaesthetic. Straight after surgery patients are given pain relief to help manage pain and they will need to try to avoid driving, sitting for long times, and excessive lifting and bending for about 4 weeks. Heavy exercise (gym) should also be avoided up to 3 months to minimize the risks of the disc prolapse recurring. For the injection patients lie on their stomach so the injection site can be numbed with local anaesthetic. Using X-ray the doctor will guide the needle containing the medication directly into the area believed to be causing the problem. The procedure takes about 15 minutes and after 30-45 minutes of observation, patients should be able to go home. Patients will be advised against driving home, but should be able to return to normal activities the following day. There may be slight discomfort for a few days as a result of the injection itself and it can be up to 7-10 days before patients feel the maximum benefit. Sometimes people suffer headaches and dizziness straight after the injection; these side effects are usually very temporary. Other risks include blood clot formation, allergic reaction to the drugs or infection at the injection site. These risks are rare. This study is needed because it is currently hard for doctors and patients to choose between the treatments - surgery is more serious for patients and takes longer to recover from but removal of the disc prolapse may offer long term or permanent relief of symptoms. The injection numbs the painful nerve and reduces inflammation while the body tries to heal itself. It could relieve the symptoms for weeks or permanently, but once the injection wears off some or all of the pain could come back. Being part of the study means attending four clinic visits in total, one more clinic visit than would usually take place and there will be some short questionnaires to complete. As well visits to the hospital the questionnaire will be sent to patients by post at about 30 weeks and 42 weeks after treatment. The last clinic visit will occur around 54 weeks after treatment.

Research activity codes: 6.1 PHARMACEUTICALS;6.4 SURGERY
Health categories: MUSCULOSKELETAL