Boston Virgin Back Study
Research type
Research Study
Full title
A prospective single centre pilot study to investigate the response to 1000Hz frequency in patients with spinal cord stimulation with intractable neuropathic pain who have not undergone spinal surgery (virgin back).
IRAS ID
233381
Contact name
Vivek Mehta
Contact email
Sponsor organisation
Barts Health NHS Trust
Duration of Study in the UK
1 years, 9 months, 30 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 density (HD) frequency. This works by delivering energy to site of stimulation below the parathesia threshold, so minimal or no parathesia is experienced.
Only one study has been completed previously using HD frequency on patients with FBSS. The major findings from these studies have found that when compared to conventional SCS (uses a frequency of 40-80 Hz) that HD frequency has provided better pain relief with minimal or no parathesia. However, these settings have not been done in patients who suffer from neuropathic pain and have not had any previous spinal surgery
REC name
London - London Bridge Research Ethics Committee
REC reference
18/LO/0365
Date of REC Opinion
24 May 2018
REC opinion
Further Information Favourable Opinion