Autonomic tone in patients treated with spinal cord stimulator
Research type
Research Study
Full title
Prospective, open label, single site pilot study to assess the effects of spinal cord stimulation on autonomic tone in patients with failed back surgery syndrome.
IRAS ID
164639
Contact name
Sheila Black
Contact email
Sponsor organisation
The Leeds Teaching Hospitals NHS Trust
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
Failed Back Surgery Syndrome (FBSS) is a chronic painful condition which results in persistent back and/or leg pain following spinal surgery. The National Institute of Clinical Excellence recommends spinal cord stimulation (SCS) as a treatment for FBSS. In our institution, 85% of patients who try the SCS get good pain relief. One of the suggested ways that SCS produces pain relief is via autonomic nerves, which also control blood pressure and heart rate. Some patients with chronic pain have increased activity in their autonomic nerves and we think that these people may be more likely to benefit from SCS than those who have normal autonomic activity.
We will measure autonomic function in this patient group to establish the level of autonomic activity. We will also compare autonomic nerve activity before and after SCS implant, to assess if SCS has any effect on autonomic function.
This is a prospective single-centre open-label trial to be undertaken in England. Ten participants will be recruited. Screening for study suitability will be undertaken if they are listed for high frequency SCS implantation.
We will measure autonomic activity on 2 occasions: before SCS implant and 6 months after. We will measure Heart Rate Variability (HRV), Baroreceptor sensitivity (BRS) and Muscle Sympathetic Nerve Activity (MSNA) using microneurography.
We propose to measure autonomic tone in patients with FBSS as these patients constitute a large proportion of the patients in whom we implant SCS, and the ability to predict those patients who will benefit, and those who will not, would significantly improve patient outcome and safety. According to our research, microneurography has not yet been studied in patients with FBSS, so this will be an important study to establish the extent of sympathetic activation in these patients prior to SCS implantation.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
15/YH/0001
Date of REC Opinion
16 Feb 2015
REC opinion
Further Information Favourable Opinion