New trial for "revolutionary" chronic back pain treatment

A new trial which could revolutionise the way chronic back pain is treated on the NHS has been launched by Guy’s and St Thomas’ NHS Foundation Trust.

The ground-breaking Modulate-LBP study will investigate whether a pioneering treatment known as spinal cord stimulation can treat chronic back pain.

Around 10 million people in the UK suffer from back pain. The condition is the leading cause of disability in the UK and it costs the economy around £12 billion a year.

Spinal cord stimulation is an alternative to major back surgery and works by delivering small electrical currents to the spinal cord, which disrupt pain signals to the brain. The treatment is delivered by a lead connected to a matchbox-sized battery-powered generator, with both implanted under the skin near the lower back during a minor surgical procedure.

The Modulate-LBP study will involve nearly 100 people who have not had previous back surgery. Participants will all have the same procedure to implant the device, but only half will be activated after the surgery. They will be monitored for six months, and results will be compared between both groups. This is a ‘double-blind’ study, so the participants will not know which group they are in, and neither will the staff collecting the results.

The study, which is funded by the National Institute for Health Research (NIHR), marks the first time in the world that a non-commercial body has funded a spinal cord stimulation trial which will test the treatment against a ‘sham’ procedure. Previously only commercial companies have carried out this type of research.

Dr Adnan Al-Kaisy, consultant in pain medicine and neuromodulation at Guy’s and St Thomas’ and chief investigator for the study, said: “This unique study has the potential to completely revolutionise how we treat chronic back pain on the NHS. Unlike major back surgery, spinal cord stimulation is reversible and patients can be treated in a day, so it’s very cost effective.

“There is existing research that shows that, for many patients, spinal cord stimulation can work very well. By testing the treatment against a sham surgical procedure this study will, for the first time, provide a robust, definitive judgement on whether or not the procedure really works. At the moment Guy’s and St Thomas’ is one of only a few centres in the UK to offer this therapy to patients. If the study finds that it is effective we hope that it will be used more widely, allowing more patients to have access to it across the UK.”

Dr Al-Kaisy added: “Due to our increasingly sedentary lifestyles we are seeing more and more patients with chronic back pain. The condition can be extremely debilitating. It causes more disability than any other condition and millions of working days are lost to it, so the cost to society is huge.”

Dean Walker, 42, from Chelmsford in Essex, had spinal cord stimulation therapy six years ago at Guy’s and St Thomas’ after suffering from chronic back pain for more than six years following a fall at work.

Dean, a father of three, said: “After I injured my back the pain gradually got worse and the painkillers weren’t helping. Eventually I had to give up my job and I became very dependent on my wife, Jess. She had to do everything for me, including putting my shoes on and helping me get to the toilet. It was an extremely difficult time.

“I noticed an immediate difference to the level of pain in my back after I had spinal cord stimulation treatment at Guy’s and St Thomas’. I’ve been completely taken aback by how well the treatment has worked. I’ve drastically reduced the amount of painkillers I take and I’m now able to dress myself and play with my children. I feel like I’ve got my life back.”

Collaborators working on the Modulate-LBP trial include King’s College London, the University of Oxford, the University of Liverpool, the University of Exeter, the University of Southampton, and South Tees Hospitals NHS Foundation Trust.
 
Guy’s and St Thomas’ are leading the recruitment drive for the Modulate-LP trial. If you would like to take part in the trial you need a referral from your GP.

The results from the Modulate-LP trial are expected in late 2020.