£1.8million trial to evaluate treatment for chronic severe low back pain

Researchers at Keele have been awarded £1.8million from the National Institute for Health Research (NIHR) to investigate if an NHS procedure for chronic severe low back pain can provide pain relief.

NIHR Professor Nadine Foster from Keele University is part of the research team led by Dr Vikki Wylde from the University of Bristol, and in collaboration with North Bristol NHS Trust and the University of Southampton.

The study named, RADIofrequency denervation for Chronic And moderate to severe Low back pain (RADICAL), is a randomised controlled trial to find out if radiofrequency denervation, a procedure already used in the NHS, is effective at providing pain relief. Low back pain is one of the leading causes of disability worldwide, affecting 10-15% of adults. One type of low back pain is caused by the small joints between the bones in the lower back, and treatments include painkillers, exercise and talking therapies. However, if people do not get better with these treatments then they can be offered radiofrequency denervation.

Radiofrequency denervation involves placing a needle in the nerve to the painful joint, which is heated up to cause a break in the nerve. The purpose of this is to stop the nerve sending pain messages to the brain. Radiofrequency denervation is low risk and there are around 13,000 procedures performed each year in the NHS. Despite its use in the NHS, it is not known how well this procedure works for reducing pain or whether it is value for money for the NHS.

To answer this question, the RADICAL trial will recruit 250 patients from pain management and spinal centres across the UK. Half of the participants will be randomised to receive ‘real’ radiofrequency denervation and half to receive ‘placebo’ denervation. The placebo treatment will involve placement of the needle in the nerve but without heating it up, so the nerve is not affected. Participants will then be asked to complete questions over the following two years to monitor symptoms, general health and use of health services.

This trial will provide important evidence to inform the provision of services and ensure that people with long-term and disabling low back pain receive the best care.

Co-investigator NIHR Professor Foster, a physiotherapist and senior member of the team in the School of Primary, Community and Social Care, and in the School of Allied Health Professions at Keele University, said: “I’m delighted to be part of the trial and know it will make an important contribution to NHS decision-making about this procedure in future. Success with the RADICAL study is also evidence of Keele’s growing success in gaining funding from the NIHR Health Technology Assessment programme, the largest funder of clinical trials in the NHS”.