Spinal Cord Stimulation for the management of Failed Back Surgery Syndrome, Complex Regional Pain Syndrome (Type 1), and Chronic Refractory Angina

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1 COMMISSIONING POLICY Spinal Cord Stimulation for the management of Failed Back Surgery Syndrome, Complex Regional Pain Syndrome (Type 1), and Chronic Refractory Angina July 2008 Distribution list Worcestershire Primary Care Trust GP Practices For Information: All providers Final Version July 2008 Page 1 of 7

2 Commissioning policy for Spinal Cord Stimulation Spinal Cord Stimulation will be considered after local assessment and optimisation of standard therapy for the following indications: Failed back surgery syndrome a Complex regional pain syndrome type I Chronic refractory angina b Spinal cord stimulation will not be funded in the following indications due to insufficient evidence of benefit: Complex regional pain syndrome type II Critical leg ischaemia Painful diabetic neuropathy. It is expected that referrals will be made by the local pain specialists to the regional centre for further consideration of implantation. 1. Spinal Cord Stimulation: 1.1 Spinal Cord Stimulation (SCS) is a form of neuromodulation therapy for the treatment of certain types of chronic pain. It involves an electrical generator and leads that deliver pulses to a targeted spinal cord area representing the region of pain. The leads can be implanted surgically or through the skin. The exact mechanism of action of SCS is poorly understood but it is thought to inhibit pain transmission in the dorsal horn of the spinal cord. The effect is to induce parasthesia or tingling over the area represented. 1 Complications include lead migration or fracture (22%) and local infection (3%-8%). 2,3 No major adverse events have been reported. Effective pain relief for up to 10 years post insertion has been documented. 2 Replacement of battery and or electrodes may be needed every 2-8 years depending on pulse settings used In a consensus document, the British Pain Society (BPS) states that the evidence for SCS is increasing and that it is not currently available to all patients who may benefit. Due to the impact that pain can have on function, behaviour, quality of life and psychological well-being, BPS suggest that multidisciplinary teams should manage those with chronic pain. 1 Such facilities can offer a range of additional physical and psychological treatments on an individual basis, for example graded exercises, self-management and coping techiniques. 1 Multidisciplinary assessment also results in careful selection of patients for SCS, who are most likely to benefit. In the case of Worcestershire PCT, the main service provider would be the Pain Management Programme at Dudley Group of Hospitals NHS Trust. 2. Supported Indications for SCS 2.1 The BPS states that good indications (likely to benefit) for SCS are as follows: a With primarily neuropathic and NOT axial back pain b After multidisciplinary rehabilitation and transcutaneous electrical nerve stimulation Final Version July 2008 Page 2 of 7

3 Failed back surgery syndrome (FBSS) FBSS refers to the persistence or recurrence of neuropathic pain, frequently experienced in the legs, after surgery intended to relieve such pain. 4 People with FBSS typically experience pain, disability and reduced quality of life (QOL). 5 A review 5 and recent RCTs have found that SCS is superior to conventional management for FBSS 4 and is an alternative to redo surgery. 6 The number needed to treat for a 50% reduction in pain is about 2.4. SCS can improve leg and back pain relief, quality of life, and functional capacity, as well as treatment satisfaction. 4 A recent meta-analysis 7 of effectiveness and cost effectiveness of SCS for FBSS concluded that it was effective and although there is no economic evaluation, costs were found to be less than conventional management. This is despite increased initial costs and is due mainly to reduced requirement for medical care. The break even point compared with conventional medical management was reported at approximately 2.5 years. Complex regional pain syndrome (CRPS) CRPS is a chronic condition characterised by severe pain, impaired function, cold or warm sensation and other features such as dry or sweaty skin and abnormal skin colour, which affects a region of the body, most commonly the hands or feet. There are two forms of CRPS, type I (without a demonstrable nerve lesion) and type II (with a peripheral nerve lesion). Patients with the syndrome have chronic refractory pain as the primary symptom, often accompanied by sensory changes, swelling, and allodynia. The exact cause is unknown, however CRPS often occurs after some form of insult to the area affected. Figures from Sweden indicate an incidence of CRPS I of 0.5-1/100,000 adults per year. 8 The best evidence for SCS is for CRPS type I. 8 Kemler 9 found that SCS was effective in patients, who had failed standard therapy and reduced pain by at least 50% in 50% of patients compared with physiotherapy. Quality of life was improved and there was no effect on function. These results were maintained at 2-year follow up, 10 however at five years the continued reduction in pain became non-significant. 11 Cost effectiveness studies concluded that SCS became more cost effective after initial high costs at 3 years due mainly to reduced contact with medical services. Cost per Quality Adjusted Life Year (QALY) was calculated at 22,500 Euros. 7,12 Chronic refractory angina (CRA) CRA is coronary heart disease causing stable angina: that cannot be controlled with optimal medical therapy where revascularisation (Percutaneous Transluminal Coronary Intervention (PTCI) or Coronary Artery Bypass Graft (CABG)) is either unfeasible or where the risks cannot be justified Angina symptoms tend to recur in those who have had PTCI or CABG and as people live longer there will be increasing number of patients who suffer from refractory angina. 13 The European Society of Cardiology recommends that SCS should only be considered if the patient continues to suffer from disabling angina despite Final Version July 2008 Page 3 of 7

4 cognitive behavioural intervention and the use of transcutaneous electrical nerve stimulation (TENS). 14 Cardiac rehabilitation can improve exercise tolerance, reduce the frequency of angina episodes, improve quality of life, and reduce mortality. 15 The National Refractory Angina Centre (NRAC) in Liverpool takes such an approach prior to more expensive technological interventions such as SCS. NRAC recognise that fear and misunderstanding can dominate the picture and patient education is central to their treatment approach. NRAC reports that targeted behavioural therapy and education can have positive effects on angina episodes, incidence of myocardial infarctions, quality of life, readmissions and future costly palliative procedures. 16 SCS can improve quality of life, reduce ischaemic episodes, reduce use of antianginal drugs and reduce frequency of hospitalisation with very little risk. 17,18,19 When CABG and SCS were compared, they were found to be comparable in terms of symptom relief, quality of life and survival. 18 This trial included patients in whom: CABG was an option for symptomatic, not prognostic benefit; surgery was deemed high risk and PTCI was not possible. These results established SCS as an alternative to CABG in high risk patients. SCS is also more cost-effective than CABG. 20 A recent placebocontrolled randomised study demonstrated that SCS improved functional status and symptoms in patients not suitable for CABG or PTCI. 19 SCS is safe and effective in patients where: neither CABG nor PTCI are possible; as an alternative to redo coronary artery surgery; or CABG in high-risk patients. There are no serious complications associated with SCS use in refractory angina and SCS does not mask the pain of myocardial infarction. 3. Indications not supported for SCS 3.1 The following indications are not supported by Worcestershire PCT for SCS: Critical lower limb ischaemia Critical lower-limb ischaemia occurs when resting blood flow does not meet the metabolic requirements of tissues. This results in pain at rest, reduced mobility, ulcers and, unless surgical revascularisation is possible, amputation is a common outcome. 21 SCS has been proposed as a treatment for ischaemic pain and also to delay amputation, however there is a lack of consistency between trials. Although SCS reduces pain 22,23, the largest RCT conducted found that pain was reduced equally as well with conventional analgesia. 24 Trials looking at transcutaneous oxygen pressure were subject to selection bias, as this is a known prognostic factor. 24,25,26 SCS may reduce the rate of amputation 23,27, although the effect is uncertain, likely to be small and not cost-effective. 27 Amputation is still considered a treatment option, as amputation leads to better pain relief than other treatments, at the cost of a temporary reduction in mobility. 22 Finally SCS has never been considered locally as an option in critical limb ischaemia (personal communication Mr R Downing). On the basis of these findings, SCS will not be supported for the treatment of pain associated with peripheral vascular disease. Diabetic neuropathy Peripheral neuropathy is a long term complication of diabetes. Although most patients will experience painless neuropathy, a small proportion will have Final Version July 2008 Page 4 of 7

5 painful neuropathy. Most can be treated with conventional therapies (personal communication Dr P Newrick). Tesfaye et al. 28 conducted a small placebo controlled non-randomised study of 10 patients, who had not responded to conventional therapy, of SCS alternated with placebo (stimulation turned off). 8 out of 10 patients had statistically significant pain relief compared with baseline measurements and placebo, which lasted for the study duration (14 months). Exercise tolerance also increased. The two patients who didn t benefit had lost vibration sense and may indicate dorsal column damage. Longer term follow up to 7.5 years has shown continued benefit Treatment costs The costs of treatment with SCS are as follows: Hardware: 14,000-18,000 + VAT HRG code is R11 at 3,164 (surgery is normally performed by a neurosurgeon and therefore funded by the Hereford & Worcestershire Local Collaborative Commissioning Board (H&WLCCB) Follow up: post implant follow up then 6 monthly. Outpatient appointments (pain management) are at the relevant national tariff Follow-up appointment 83. Replacement of batteries/electrodes (possibly every 2-8 years) approx 12, Implications for Worcestershire: 5.1 It is difficult to judge the number of cases that may qualify for SCS in Worcestershire for the approved indications. In addition, there are limited numbers that can be implanted at the existing regional centres, where the decision to implant will ultimately take place (80 cases in total per year at Oxford/Dudley/Bath personal communication Medtronic). Local clinicians state that the numbers are likely to be very small. In the years , the complex case panel has received two new requests for SCS for CRPS (approved) and one request for SCS for FBSS (rejected). Other requests for replacement of SCS components have been approved. CRPS - on the basis of Swedish figures and local clinical opinion approximately 2-5 cases per year FBSS - on the basis of modelling from Medtronic and local opinion approximately 4-6 patients per year CRA on the basis of local clinical opinion 1-4 cases per year 6. Requests for SCS not covered by this commissioning policy 6.1 Requests for SCS not covered by this commissioning policy will be considered on an exceptional case basis in line with the PCT Process for Managing Individual Patient Requests and Complex Cases. Final Version July 2008 Page 5 of 7

6 7. References 1. Spinal cord stimulation for the management of pain: recommendations for best clinical practice. The British Pain Society; Available at: (accessed 17/01/08). 2. Cameron T. Safety and efficacy of spinal cord stimulation for the treatment of chronic pain: a 20-year literature review. J Neurosurg 2004;100: Turner JA, Loeser JD, Deyo RA, Sanders S. Spinal cord stimulation for patients with failed back surgery syndrome or complex regional pain syndrome: a systematic review of effectiveness and complications. Pain 2004;108: Kumar K, Taylor R, Jacques L, Eldabe S, Meglio M, Molet J et al. Spinal cord stimulation versus conventional medical management for neuropathic pain: a multicentre randomised controlled trial in patients with failed back surgery syndrome. Pain 2007;132: Spinal Cord Stimulation for Neuropathic Pain: Health Technology Literature Review. Medical Advisory Secretariat, Ontario Ministry of Health and Long- Term Care, Toronto, Ontario, Canada. March Available from: /rev_scs_ pdf (accessed 18/01/08). 6. North RB, Kidd DH, Farrokhi F, Piantadosi SA. Spinal cord stimulation versus repeated lumbrosacral spine surgery for chronic pain: a randomized control trial. Neurosurgery 2005; 56: Taylor RS. Spinal cord stimulation in complex regional pain syndrome and refractory neuropathic back and leg pain/failed back surgery syndrome: results of a systematic review and meta-analysis. J Pain Symptom Manage 2006;31:S13-S Taylor RS et al. Spinal cord stimulation for complex regional pain syndrome: a systematic review of the clinical and cost effectiveness literature and assessment of prognostic factors. Euro J Pain 2006;10: Kemler MA et al. Spinal cord stimulation in patients with chronic reflex sympathetic dystrophy. NEJM 2000;343: Kemler MA et al. The effect of spinal cord stimulation in patients with chronic reflex sympathetic dystrophy: two years follow-up of the randomised control trial. Ann Neurol 2004;55: Kemler MA et al. Spinal cord stimulation for chronic reflex sympathetic dystrophy five year follow up. N Engl J Med; 354: Kemler MA et al. Economic evaluation of spinal cord stimulation for chronic reflex sympathetic dystrophy. Neurology 2002;59: Mannheimer C, Camici P, Chester MR, et al. The problem of chronic refractory angina. Report from the ESC Joint Study Group on the Treatment of Refractory Angina. Eur Heart J 2002;23: Guidelines on the management of stable angina pectoris. European Society of Cardiology Available from: (accessed 18/02/08). 15. Jolliffe JA, Rees K, Taylor RS, Thompson D, Oldridge N, Ebrahim S. Exercise-based rehabilitation for coronary heart disease. Cochrane Database of Systematic Reviews 2000, Issue 4. Art. No.: CD DOI: / CD Available from (accessed 21/2/08). 16. Chester MR. Developing a novel angina service. Presentation to Gloucester PCT Nov Available from: Final Version July 2008 Page 6 of 7

7 7.pdf (accessed 03/03/08). 17. Mannheimer C et al. Electrical stimulation versus coronary bypass surgery in severe angina pectoris: the ESBY study. Circulation 1998;97: Ekre O et al. Long term effects of spinal cord stimulation and coronary artery bypass grafting on quality of life and survival in the ESBY study. Eur Heart J 2002;23: Eddicks S et al. Thoracic spinal cord stimulation improves functional status and relieves symptoms in patients with refractory angina pectoris: the first placebo-controlled randomised study. Heart 2007;93: Andrell P. Cost-effectiveness of spinal cord stimulation versus coronary artery bypass grafting in patients with severe angina pectoris long term results from the ESBY study. Cardiology 2003;99: The Trans-Atlantic Inter-Society Consensus Document on Management of Peripheral Arterial Disease Available from: pad.org/upload/ssrubriqueproduit/fichier2/597.pdf (accessed 04/03/08). 22. Jivergard LE et al. Effects of spinal cord stimulation (SCS) in patients with inoperable severe lower limb ischaemia: a prospective randomised controlled study. Eur J Vasc Endovasc Surg 1995;9: Ubbink DT, Vermeulen H. Spinal cord stimulation for non-reconstructable chronic critical leg ischaemia. Cochrane Database of Systematic Reviews 2003, Issue 3. Art. No.: CD DOI: / CD pub2. Available from: (accessed 15/02/08). 24. Klomp et al. Spinal cord stimulation in critical limb ischaemia: a randomised trial. Lancet 1999;353: Ubbink DT et al. Microcirculatory investigations to determine the effect of spinal cord stimulation for critical leg ischaemia: the Dutch multicentre randomised controlled trial. J Vasc Surg 1999;30: Amann W et al. Spinal cord stimulation in the treatment of nonreconstructable stable critical leg ischaemia: results of the European peripheral vascular disease outcome study (SCS-EPOS). Eur J Endovasc Surg 2003;26: Klomp et al. Spinal cord stimulation is not cost-effective for non-surgical management of critical limb ischaemia. Eur J Vasc Endovasc Surg 2006;31: Tesfaye et al. Electrical spinal cord stimulation for painful diabetic peripheral neuropathy. Lancet 1996;348: C. Daousi, S. J. Benbow, I. A. MacFarlane. Electrical spinal cord stimulation in the long-term treatment of chronic painful diabetic neuropathy. Diabetic Medicine 2005;22: Final Version July 2008 Page 7 of 7

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