CHRONOS
Research type
Research Study
Full title
A prospective single centre, double-blind, randomised study to evaluate the response of Fast-Acting Sub-perception Therapy (FAST) pain relief and wash-in/wash-out frequency sensitivity above and below 90Hz.
IRAS ID
281237
Contact name
Vivek Mehta
Contact email
Sponsor organisation
Barts Health NHS Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Spinal Cord stimulation (SCS) is a common intervention used in patients who suffer from chronic nerve pain following back surgery. This is known as failed back surgery syndrome (FBSS). Equally, the National Institute of Clinical Excellence (NICE) who work with the NHS, recommend suitable medicines and treatments for patients in their guidelines; suggest that SCS can be used in patients who have never had back surgery. The is no outcome data to define that SCS works in patients with neuropathic back pain, therefore this study will provide clinical data to see if this works.
SCS delivers mild electrical impulses to the nerves along the spinal cord. This blocks the pain pathway from reaching the brain. This helps manage the pain experienced the lower back.
SCS consists of three components:
1. Implantable pulse generator (IPG): this is a battery power source that provides the electrical pulses according to set programmes and delivering different frequencies at a set current.
2. Lead: A set of thin wires; one end connected to the IPG and the other end is inserted along the spinal cord. The wires have electrodes near the tips. These electrodes transfer electrical pulses to area of stimulation site.
3. External controller: A remote that controls the settings and programmes of the IPG.
A common side effect of the conventional system is that patients may experience ‘pins and needles’, tingling, numbness, known as parathesia at site of stimulation. This can be particularly uncomfortable for patients. However, parathesia can be eliminated by changing certain settings on the stimulator. This could include increasing the frequency of the stimulator known as high frequency (HF) frequency. This works by delivering energy to site of stimulation below the parathesia threshold, so minimal or no parathesia is experienced.
This approach is known as sub-perception SCS (Kapural et al., 2015). However, this method is very energy intensive,requires patients to recharge every 1-2 days and exhibits a slow “wash-in” time (i.e.the time between therapy activation and relief from pain).
REC name
London - Chelsea Research Ethics Committee
REC reference
21/LO/0639
Date of REC Opinion
17 Nov 2021
REC opinion
Further Information Favourable Opinion