MODULATE-LBP
Research type
Research Study
Full title
Multicentre, Double Blind, Randomised Sham-Controlled Trial of 10kHz High- Frequency Spinal Cord Stimulation for Chronic Neuropathic Low Back Pain (MODULATE-LBP)
IRAS ID
232729
Contact name
Elizabeth Bruna
Contact email
Sponsor organisation
Guy's & St Thomas' Foundation NHS Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 7 months, 29 days
Research summary
This is a clinical trial that serves to determine if stimulating the spinal cord at 10kHz using an implanted electrode can be effective in helping patients with long term low back pain. These patients have to have a component of their pain being nerve related and not as a result of previous spinal surgery. As conventional spinal cord stimulation at much lower frequencies (40-70Hz) is accepted for treating leg pain, usually as a result of previous spinal surgery it has poor effect on the pain that is coming from the back itself. We did some preliminary studies on using 10kHz spinal cord stimulation for low back pain without prior surgery and found very promising results that we wish to test using a more robust and controlled study design.
The study involves selecting patients with predominant low back pain with a neurophatic nerve component but no previous spinal surgery. All patients will be implanted with the device and for the duration of the study (6 months) they will be randomized to receive either active or dummy (placebo) treatment. One half of patients will have the spinal electrode activated and the other half will have a dummy electrode activated. After the study period all will be given the option of having the spinal electrode activated if it was not done so before. We aim to measure pain response and effects these devices will have on function, quality of life and medication use. In addition, we will look at any issues regarding safety and adverse effects.
REC name
London - Camberwell St Giles Research Ethics Committee
REC reference
18/LO/1031
Date of REC Opinion
3 Jul 2018
REC opinion
Further Information Favourable Opinion