Spinal cord stimulation - formal response sent

11th Dec 2017

NICE gave us the opportunity to comment on the MTEP on Senza and after consulting with the British Pain Society Membership, the following submission was made.  

Thank you for giving us the opportunity to comment on the MTEP on Senza.  The British Pain Society welcomes the support of NICE in the use of latest technology and evidence for improving patient care by alleviating pain and other distressing symptoms.  The Council and the wider membership of the society have discussed the MTEP and a summary of the comments is given below for consideration. 

The document gives the impression that SENZA is better than all other forms of spinal cord stimulation and this is not consistent with the feedback we received from our members.  It is to be noted that the recommendations are based on one industry sponsored RCT, which was not blinded and was carried out exclusively in private practice in the USA.  There are concerns about the potential of other bias including programing bias, multiple patient contacts that could have influenced a favourable outcome and also an expectation of the participants that the new technology would yield better results.

The SENZA study has been carried out in patients with back pain following FBSS, but the MTEP has recommended that SENZA is better for all neuropathic pains.  It has been observed that majority of FBSS back pain do not have a predominantly neuropathic component; the SENZA study do not mention about using appropriate tools to screen for the severity of neuropathic pain.   We feel that the extrapolation of the recommendation to cover all neuropathic pain is based on poor study criteria.

The British Pain Society is aware of two further studies (De Andres J et al. and Thomson ST et al.) that have since been published which do not show any added advantage for SENZA over other stimulation frequencies.  There have been advances in other technologies including Burst stimulation and DRG stimulation, but these were not used as comparator for the SENZA study.    The SENZA kit is not MRI compatible and limits its use in patients who would need MRI scans for evaluation; there is a move towards MRI compatible kit to ensure patient safety as well as a better financial option.  Most of the neuromodulators in the UK are concerned about NICE recommending that this therapy is better than others as this may limit choice for patients and physicians if we are limited to one therapy.

The MTEP document states that the introduction of high frequency stimulation is unlikely to change the indications of treatment compared to traditional spinal cord stimulation, thus conferring an overall cost-benefit to the NHS.  In the SENZA study, there are good outcomes on treating leg pain and back pain in FBSS.  There may be positive evidence in the future for treatment of back pain alone in patients who have not had surgery at all. This would potentially increase the referral base quite dramatically and it should be recognised that we will probably implant more patients if evidence about HF stimulation is implemented, thus increasing the over-all costs as compared to current practice. 

The British Pain Society recommends the biopsychosocial model of pain and any treatment recommendations for the management of chronic pain should involve the multi-disciplinary team in assessing and advising pain management strategies including self-management of pain to ensure successful rehabilitation.  It is often seen that the implantation of a neurostimulator alone would not relieve pain and could result in explanting the device.  It is recommended that neuromodulation is considered as part of a multimodal strategy in pain management.

References:

1. De Andres J, Monsalve-Dolz V, Fabregat-Cid G, Villanueva-Perez V, Harutyunyan A, Asensio-Samper JM, et al. Prospective, Randomized Blind Effect-on-Outcome Study of Conventional vs High-Frequency Spinal Cord Stimulation in Patients with Pain and Disability Due to Failed Back Surgery Syndrome. Pain Med. 2017 Nov 04. PubMed PMID: 29126228. Epub 2017/11/11.

2. Thomson ST, M..Love-Jones, S. Patel,N. Jianwen W,,Que D, Moffitt, M. 29 May - 017. PATIENT RESPONSES TO PARESTHESIA-BASED SPINAL CORD STIMULATION AND KILOHERTZ FREQUENCY SPINAL CORD STIMULATION: at International Neuromodulation Society’s 13th World Congress Neuromodulation: Technology Changing Lives Edinburgh, Scotland, United Kingdom May 27–June 1, 2017. Abstract at Neuromodulation. 2017;20:e336–e783.