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Spinal cord stimulation for the management of pain: recommendations for best clinical practice.

Contents

1. Executive summary
2. Need for recommendations
3. Scientific rationale
4. Evidence
5. SCS: Appropriate context for delivery
6. Patient selection
7. Timing
8. Techniques of stimulation
9. The procedure
   9.1 Preoperative assessment and preparation
   9.2 The theatre environment
   9.3 Post-anaesthesia care and ward management
   9.4 Discharge and ongoing care
10. Special precautions
11. Complications of SCS
12. Patient information
13. Audit
Appendix 1: SCS literature review
Appendix 2: Summary of SCS RCTs


Spinal cord stimulation (SCS) is a form of therapy with a supportive evidence base, and has been used for the treatment of pain since 1967. It is strategically aimed at reducing the unpleasant sensory experience of pain and the consequent functional and behavioural effects that pain may have. When SCS is used to treat patients with chronic pain, it is important that the treatment is delivered within the context of a full understanding of the impact that pain has upon the patient, including its effect on quality of life. Pain can and does affect patients' psychological well-being and social functions. These recommendations give guidance to practitioners delivering this treatment, to those who may wish to refer patients for SCS, and to those who care for patients with stimulators in situ. The recommendations also provide a resource for organisations that fund SCS.

1. Executive summary

1.1. Persistent pain is common. Whereas acute pain may only impact by interrupting current activity, episodic and persistent pain is likely to interfere with one or more aspects of a person's life and to affect his or her sense of identity.

1.2. There is clinical evidence from randomised controlled trials (RCTs) to support the use of SCS for pain from failed back surgical syndrome (FBSS), complex regional pain syndrome (CRPS), neuropathic pain, and ischaemic pain. The National Institute for Clinical Excellence (NICE) published guidance on SCS for chronic pain of neuropathic or ischaemic origin in 2008 (ref - TA 159). It recommended SCS for severe, prolonged pain responsive to a trial of stimulation in FBSS, CRPS, and neuropathic pain. NICE concluded that there was insufficient evidence of cost-effectiveness to recommend the use of SCS outside of controlled trials in ischaemic pain. We concur that further high-quality research on the use of SCS for chronic pain of ischaemic origin is required.

1.3. Not all patients are suitable for SCS.

1.4. A multidisciplinary pain-management team is the most appropriate context in which to provide SCS.

1.5. Not all patients will have the resources to receive SCS therapy, but this does not detract from the evidence supporting its use. It remains an appropriate form of therapy.

1.6. Members of the team must include clinicians competent to deal with the complications of SCS.

1.7. SCS may be delivered in parallel with other therapies and should be used as part of an overall rehabilitation strategy.

1.8. Techniques of SCS vary. Clinical teams must have and maintain the competencies needed to offer the most appropriate technique according to an individual patient's needs.

1.9. Clinicians performing this intervention should insert a sufficient number of SCS systems to maintain competence (see 5.8).

1.10. SCS must be performed in an operating theatre environment suitable for implant work, with appropriate anaesthesia and post-anaesthesia care facilities. Patients must have comprehensive access to advice if they experience problems with the stimulating system.

1.11. The most common organism to infect SCS systems is Staphylococcus aureus.

1.12. SCS is a long-term treatment for a chronic condition, and appropriate infrastructure for ongoing surveillance and support must be in place.

1.13. The compatibility of SCS with magnetic resonance imaging (MRI) is problematic. While there have now been small series of cases reported without problems, concerns remain and other imaging modalities should be used if at all possible. If MRI is required, the advice of a radiologist should be sought and, depending on imaging site and sequencing, imaging may be possible. However, at present, the majority of radiologists would not advise using MRI with an SCS in situ.

2. need for recommendations

2.1. Persisting pain occurs in up to one-half of the adult population at some time in their lives. One in 10 adults with persisting pain would describe themselves as being severely disabled by it. Most patients with chronic pain can be managed in primary care, but some need specialised, multidisciplinary assessment and management.

2.2. Patients who are referred to a pain service have frequently seen a number of other secondary-care specialists and have usually been extensively investigated.

2.3. Multidisciplinary pain services should offer patients a range of evidence-based interventions. It is rarely possible to provide complete pain relief. Patients should also be offered advice on self-management and coping strategies, in tandem with any interventions.

2.4. Persisting pain is difficult to treat, and some patients will continue to experience intrusive and distressing symptoms despite a variety of surgical and electro-thermal interventions.

2.5. SCS may be helpful in carefully selected patients. However, many patients will not be helped by SCS.

2.6. Some indications for SCS are well-established (e.g. FBSS, CRPS, neuropathic pain, refractory angina pectoris (RAP), peripheral vascular disease), and others are emerging (e.g. visceral pain, interstitial cystitis). As knowledge and expertise develop, the techniques change and may be refined.

2.7. At the time of writing, many patients in SA are refused therapy with SCS due to lack of funds, or to medical assessors' lack of knowledge on the subject. This does not imply that this form

of therapy is not well-established or not supported by good scientific studies.

2.8. The recommendations will:

a) Guide healthcare professionals regarding:

* Whom to refer

* Whom not to refer

* What to tell patients

* How to look after patients who have had SCS implanted

* How to deal with complications after SCS implantation.

b) Promote best clinical practice for clinical teams involved in providing SCS, to enable them to:

* Select patients appropriately

* Prepare patients for the therapy

* Deliver SCS safely with minimal morbidity

* Optimise outcomes

* Provide appropriate continuing care.

c) Allow patients to make an informed decision.

d) Inform commissioners of healthcare services and medical funders.

3. Scientific rationale

3.1. The use of stimulation techniques in modern pain medicine dates from the publication of the gate theory of Melzack and Wall in 1965, which described how stimulating neural pathways carrying innocuous (non-painful) information could influence the onward transmission of noxious information in the nervous system.

3.2. Although the introduction of SCS was inspired by the gate theory, its mechanism of action involves more than a direct inhibition of pain transmission in the dorsal horn of the spinal cord. If this were the principal mode of action, then SCS would control nociceptive pain, and this is not generally the case. Pain modulation by SCS also involves supra-spinal activity via the posterior columns of the spinal cord, probably recruiting endogenous inhibitory pathways. There is also a pronounced autonomic effect, though the mechanisms of this are not fully understood.

3.3. The preservation of topographically appropriate posterior column function seems to be necessary for SCS to be effective, but there is debate regarding which elements are necessary and to what degree.

4. Evidence

4.1. RCTs of SCS have been undertaken for FBSS, complex CRPS type 1, RAP, and chronic critical limb ischaemia (CLI). A summary of these RCTs and their findings is listed in Appendix 2. In addition to RCT evidence, systematic reviews of SCS have included case series and observational comparisons, particularly for FBSS and CRPS (see Appendix 2). It should be noted that present funding models in SA include only FBSS, CRPS, and some peripheral neuropathies including post-herpetic neuralgia (PHN) and diabetic peripheral neuropathy (DPN). These guidelines do include some data on the other described pathologies but shall be more focused on the former conditions.

* RCTs demonstrate that SCS is more effective for radicular (limb) pain following spinal surgery than either reoperation or management by nonsurgical therapy.

4.2. NICE published guidance on SCS for chronic pain of neuropathic or ischaemic origin in 2008 (ref - TA 159). With provisos regarding the severity and duration of pain and a trial of stimulation after multidisciplinary assessment, SCS is recommended as a treatment option for adults with chronic pain of neuropathic origin. This recommendation was based on RCT data and robust cost-effectiveness analyses for trials in FBSS and CRPS. The recommendation was extended to include all causes of chronic pain of neuropathic origin on the advice of nominated specialists. SCS is not, however, recommended for chronic pain of ischaemic origin, except in the context of research as part of a clinical trial.

4.3. NICE felt unable to recommend SCS for chronic pain of ischaemic origin for two reasons: lack of high-quality RCT data, and insufficient data to support robust economic modelling. Functional outcomes were considered in addition to improvements in pain levels.

4.4. In the case of CLI, NICE acknowledged that non-randomised evidence suggests there may be functional benefit for certain sub-groups of people. The evidence for improvement in health-related quality of life was not robust, and it was not possible to perform a cost-effectiveness analysis.

4.5. With regard to RAP, NICE assessed that the available data did not allow accurate identification of the population to be treated, or the available comparator treatments. The committee accepted that SCS was as effective as comparator treatments in the included studies. Again, no cost-effectiveness analysis was possible.

4.6. We concur with NICE that further high-quality research on the use of SCS in chronic pain of ischaemic origin is required.

5. SCS: Appropriate context for delivery

5.1. Pain interferes with physical function and is often associated with psychological problems. All patients being considered for SCS must be assessed with regard to physical, psychological, and social functioning.

5.2. An important approach to the treatment of pain is to attempt to modulate the unpleasant sensory experience by reducing the intensity, duration and frequency with which pain is felt. Medication, nerve blocks, physical therapies and SCS are all strategies used to achieve this outcome. SCS should not be considered as a first line of therapy, and other non-invasive options for treating the pain should be considered first.

5.3. Psychological interventions - mainly cognitive-behavioural therapy (CBT) - are largely focused on mitigating the interference in function that persistent pain induces. Such treatments may be offered in conjunction with SCS.

5.4. Qualitative psychological testing does not predict outcome, but assessment by a psychologist is desirable to assess the patient's beliefs, expectations, and understanding of the treatment in relation to the condition.

5.5. A multidisciplinary pain-management team is the most appropriate context in which to provide SCS. Such a team should be able to deliver a range of therapies for pain.

5.6. The team will usually comprise several professionals. Members may include a consultant in pain medicine and one or more consultants from other relevant specialties, e.g. neurosurgery, spinal surgery, cardiology, or vascular surgery. Other members of the team might include psychologists, physiotherapists, and nurse specialists in pain management. The team must have access to a spinal surgeon or neurosurgeon competent to deal with the complications of SCS.

5.7. Clinicians performing the SCS interventions must understand the multidisciplinary management of pain. They must have and maintain relevant surgical competence in insertion of the SCS system and management of complications such as infection. This will usually be in the form of a consultant in pain medicine, neurosurgeon, or spinal surgeon.

5.8. The competence of the implanter and the activity and competence of the team must be maintained. Where a new service is being established, there should be evidence of progression toward an

annual caseload that will maintain competence, or the opportunity to regularly work within other units that have a high level of activity.

5.9. SCS is a long-term therapy. Teams must have appropriate arrangements for ongoing patient care, including availability to investigate and manage potentially serious problems such as neurological deficit, bleeding or infection. SCS is a significant commitment for patients and their healthcare team, and it is not usually appropriate for a single consultant to manage this therapy without the support of colleagues.

6. Patient selection

6.1. Patients must have an up-to-date assessment in relation to the indication for SCS.

6.2. History and physical examination should be detailed.

6.3. The indications for SCS are summarised in Table 1.

6.4. The use of SCS for other conditions such as pelvic and visceral pain has been described. Its use in these and other emerging indications should carefully be audited.

6.5. Contraindications to the use of SCS are summarised in Table 2.

6.6. Considerations regarding surgical insertion of plate electrodes are summarised in Table 3.

6.7. Many patients, such as those with pain following spinal surgery, will present a mixed neuropathic/nociceptive picture. Patients should be told that SCS will probably only help part of their pain. Teams offering SCS must be able to deliver appropriate additional therapies, including pain management programmes.

6.8. Physical and psychological co-morbidity does not preclude treatment with SCS. Patients with concurrent physical or mental illness should be assessed in close conjunction with relevant clinical teams. Cognitive impairment, communication problems, or learning difficulty resulting in failure to understand the therapy are not reasons to exclude patients from SCS, but these patients must have a cognizant caregiver and adequate social support.

6.9. The management of children being considered for SCS should be in conjunction with a specialised multidisciplinary children's pain management team.

7. Timing

7.1. SCS may be delivered in conjunction with other therapies such as medication and psychologically based therapies. If there is significant psychological distress identified at assessment, such patients may benefit from individual psychological therapy (e.g. CBT) before proceeding to SCS. For those patients who may also benefit from a pain management programme, it is preferable to provide that treatment before SCS.

7.2. SCS should be considered early in the patient's management when simple first-line therapies have failed. SCS should not necessarily be considered a treatment of last resort.

7.3. Cognitive impairment resulting in failure to understand the therapy is not a reason to exclude patients from SCS, but these patients must have a cognisant carer and adequate social support.

8. Techniques of stimulation

8.1. Stimulation of the spinal cord is by an implanted electrode powered by an implanted pulse generator (IPG). Electrodes may be inserted percutaneously via an epidural needle or surgically implanted via laminotomy. Electrodes may be bipolar or multipolar, and multiple electrodes may be used. Pulses are generated by a fully implantable battery-powered device. Rechargeable battery systems are now available and may be preferred for some patients such as those who require high current use (including systems with multiple electrodes), as these batteries have been proven to be cost-effective.

8.2. Electrodes must be placed to elicit paraesthesia that covers the region of reported pain.

8.3. It is recommended that percutaneous electrodes be placed under a local anaesthetic with minimal sedation. This optimises electrode placement and reduces the risk of inadvertent neural trauma.

8.4. Surgical electrodes require open surgery (laminotomy or partial laminectomy) for placement. This is usually carried out under a general anaesthetic. Such electrodes are less likely to be dislodged.

8.5. The electrode/s should be connected temporarily to an external stimulating device before proceeding to insertion of an IPG. This allows the patient to undergo a period of trial stimulation during which time pain relief, improvement in function, and reduction in medication may be assessed. If the outcome of the trial is favourable, then the patient may wish to proceed to IPG insertion.

8.6. The same team should carry out trial stimulation and definitive implantation.

8.7. Following IPG insertion, the patient may switch the device on and off with a hand-held programmer and may vary voltage and frequency within physician-determined limits.

8.8. IPG battery life is variable, but is usually between 2 and 8 years depending on the pattern of use and the output required. Rechargeable batteries with increased longevity are now available.

8.9. Centres offering SCS to patients should ensure that the service is appropriately funded to support ongoing system maintenance, including the need for IPG replacement in those patients who do not have a rechargeable system in situ, and the possible need for lead or system revision. Patients must be made aware of all matters relating to funding prior to any SCS procedure.

9. The procedure

9.1 Preoperative assessment and preparation

9.1.1. Patients must be investigated appropriately to determine their fitness to undergo surgery and anaesthesia or sedation.

9.1.2. The most common organism to infect SCS systems is S. aureus.

9.1.3. The patient and operator should agree preoperatively on the proposed position of the IPG.

9.1.4. There is little published evidence regarding the use of antibiotic prophylaxis for SCS. Infection of an SCS system can be a significant problem and therefore its consequences justify the use of antibiotic prophylaxis. Antibiotics should be given as a single intravenous dose prior to starting the procedure. Appropriate cover for S. aureus should be ensured.

9.2 The theatre environment

9.2.1. Standard operating and post-anaesthesia care facilities must be available.

9.2.2. The operating theatre must be suitable for implant work. A laminar flow environment is suggested.

9.2.3. X-ray screening is mandatory for percutaneous lead placement.

9.2.4. A practitioner skilled in programming and trialing SCS must be present for the percutaneous procedures.

9.3 Post-anaesthesia care and ward management

9.3.1. Programming the SCS should not begin until the patient is fully conscious.

9.3.2. Ward staff should be familiar with the aims and procedure of SCS, the condition that it is being used to manage, and the potential complications that may arise.

9.3.3. The post-operative observation regimen should consider potential complications such as spinal cord compression, neurological injury, bleeding, and infection.

9.3.4. Ward staff should be able to seek advice from a member of the implant team at any time.

9.4 Discharge and ongoing care

9.4.1. Adequate arrangements must be made for the implant team to conduct surveillance and follow-up; the patient should be able to contact an appropriate and experienced professional at any time.

9.4.2. Referring physicians must be given advice about all patients who are sent home after SCS implant.

9.4.3. In the event of complications related to the SCS or other pathology, there should be established relationships with other relevant disciplines such as spinal surgery and neurosurgery, microbiology and neuroradiology.

9.4.4. SCS is a long-term treatment for a chronic condition. Patients with non-rechargeable systems will need IPG replacement at some stage. Mechanisms should be in place to predict when this is likely to occur, so that, with planning, SCS function can be restored promptly.

9.4.5. If patients move beyond a reasonable travelling distance from the implanting centre, systems must be in place to transfer their care appropriately to other physicians.

10. Special precautions

10.1. Unipolar diathermy should be avoided in patients with SCS in situ. If its use is unavoidable, the reference plate should be positioned so that the SCS components are outside the electrical field of the diathermy.

10.2. The interaction of MRI and SCS is complex. The magnetic field may cause leads to move, resulting in loss of effect or neural damage, or heat the implant components, resulting in discomfort, tissue damage, or software malfunction. In addition, the location of the leads in relation to the site of imaging interest may corrupt the image. Patients with SCS in situ who need investigation with MRI may pose specific problems that should be discussed with an experienced neuro-radiologist. If there is any doubt about the compatibility, then alternative imaging (such as computed tomography (CT) scan or myelography) should be performed. It has been established that if MRI studies are unavoidable, then the IPG should be switched off during the scans and thereafter checked for programming errors.

10.3. The presence of a cardiac pacemaker is a relative contraindication to SCS. Most contemporary pacemakers are operated in the demand mode - they monitor intrinsic cardiac activity, and may be inhibited by spontaneous extra-cardiac electrical activity. They may sense extraneous electrical activity from SCS devices and misinterpret it as appropriate cardiac activity. The pacemaker may then either respond by inhibiting pacing or by reverting to an asynchronous pacing mode. Inhibition of pacing can be potentially dangerous for the patient; asynchronous pacing is less serious, but still compromises pacemaker function. In such circumstances, it has been suggested that bipolar pacemaker sensing should be employed, as it is inherently less sensitive to extraneous signals than the unipolar pacing mode.

10.4. Patients should be advised that airport (and other) security systems may be activated by a stimulator. Patients should carry information relating to their SCS in situations where this may be relevant.

10.5. Patients must inform their medical caregivers that they have SCS in place.

10.6. Short-wave diathermy, microwave diathermy, and therapeutic ultrasound diathermy are hazardous in patients with SCS.

10.7. Antibiotic prophylaxis is not recommended for patients with SCS systems in situ who are undergoing incidental procedures that may generate bacteraemia.

11. Complications of SCS

11.1. SCS has been used in many thousands of patients worldwide; some clinical centres have reported follow-up of >10 years. Major complications of SCS are rare, but minor ones are common. Most problems are technical, with the most common complication being lead migration. These complications should be discussed during the consent process.

11.2. Neurological damage relating to epidural electrode placement is a rare complication and may occur with both percutaneous and surgical electrodes. Damage may occur directly or from epidural haematoma or infection. These latter complications are reversible if diagnosed and treated promptly, emphasising the importance of postoperative neurological observations by experienced staff. Vigilance and access to early imaging are essential (see 10.2).

11.3. Dural puncture may occur during percutaneous insertion of electrodes. This happens most frequently with the Tuohy needle, but may occur with the guide wire or the stimulating electrode.

11.4. Infection of implanted neurostimulators is a serious problem and must never be ignored. Usually, the infection will not resolve unless the whole SCS system is explanted. Infection of the entire system is rare but can result in epidural abscess with potentially disastrous neurological consequences. In such cases explantation is required.

11.5. Patients should be aware that not only will surgery be necessary to replace a depleted IPG but that it may also be necessary to revise the electrodes or connections.

11.6. Electrode migration (see 11.1) may occur immediately following the procedure, at any time during the trial period or following IPG insertion. Cervical electrodes are more likely to be dislodged than those in the thoracic region. Migration is less likely with surgical electrodes. Recent improvements in anchor designs have been shown to reduce migration.

11.7. Other potential problems include fluid entering the connectors or electrode, lead breakage, and disconnection.

12. Patient information

12.1. The risks and limitations of SCS should be discussed with patients, who should be given written information in a form that they can understand.

12.2. Patients must be aware of the evidence for the efficacy of SCS for the indication in their case.

12.3. Patients should be given information relating to complications and outcomes.

12.4. Detailed information regarding the procedure of SCS insertion, including the operating theatre environment, is necessary.

12.5. Patients should understand that SCS provides benefit only as part of a multidimensional approach to symptom management.

12.6. Patients should understand the need for ongoing care following SCS, including the likelihood of needing further surgery.

12.7. Patients must be given adequate time to consider the benefits and burdens of the technique before consenting to treatment.

13. Audit

13.1. There is currently no national database of SCS patients.

13.2. Local audit of implanted patients is recommended.

13.3. Formal professional communication between implanting centres is strongly recommended.

Conflict of interest. Milton Raff has received research funding and honoraria from medical device and pharmaceutical companies for lectures at conferences, to attend advisory boards, to contribute to publications, and to attend meetings to support professional development. Gerrit Coetzee has received honoraria from Southern Medical and has consulted with Medtronic regarding non-pain-associated devices. Roger Melvill and johann Smuts declare no competing interests.

Appendix 1. SCS literature review

This review is based on the recently published recommendations of the British Pain Society: The British Pain Society's Spinal Cord Stimulation for the Management of Pain: Recommendations for Best Clinical Practice--a consensus document prepared on behalf of the British Pain Society in consultation with the Society of British Neurological Surgeons.

Search method

RCTs and systematic reviews were identified from searches of MEDLINE (PubMed) and the Cochrane Library based on a search conducted on 5 January 2004 and updated in September 2008.

Results

1. RCTs: FBSS

1. North RB, Kidd DH, Lee MS. A prospective, randomized study of spinal cord stimulation versus reoperation for failed back surgery syndrome: Initial results. Stereotact Funct Neurosurg 1994;62(1-4):267-272.

2. North RB, Kidd DH, Lee MS. Spinal cord stimulation versus operation for failed back surgery syndrome: A prospective, randomized controlled trial. Acta Neurochir Suppl 1995;64:106-108.

3. North RB, Kidd DH, Farrokhi F, Piantadosi SA. Spinal cord stimulation versus repeated lumbo sacral spine surgery for chronic pain: A randomised, controlled trial. Neurosurgery 2005;56(1):98-107.

4. Kumar K, Taylor RS, jacques L, 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(1-2):179-188. [http://dx.doi.org/10.1016/j.pain.2007.07.02]

2. SCS CRPS

5. Kemler MA, Barendse GA, van Kleef M, et al. Spinal cord stimulation in patients with chronic reflex sympathetic dystrophy. N Engl j Med 2000;343(9):618-624. [http://dx.doi.org/10.1016/10.1056/ NEjM200008313430904]

6. Kemler MA, de Vet HCW, Barendse GAM, van den Wildenberg FA, van Kleef M. The effect of spinal cord stimulation in patients with chronic reflex sympathetic dystrophy: Two years' follow-up of the randomized controlled trial. Ann Neurol 2004;55(1):13-18. [http://dx.doi.org/10.1002/ana.10996]

7. Kemler MA, de Vet H, Barendse G, van den Wildenberg F, van Kleef M. Spinal cord stimulatin for chronic reflex sympathetic dystrophy--five-year followup. N Engl j Med 2006;354(22);2394-2396.[http://dx.doi.org/10.1056/NEjMc055504]

3. RAP

8. De jongste Mj, Staal Mj. Preliminary results of a randomized study on the clinical efficacy of spinal cord stimulation for refractory severe angina pectoris. Acta Neurochir Suppl (Wien) 1993;58:161-164.

9. De jongste Mj, Hauttvast RW, Hillege HL, Lie KI. Efficacy of spinal cord stimulation as adjuvant therapy for intractable angina pectoris: A prospective, randomized clinical study. Working Group on Neurocardiology. j Am Coll Cardiol 1994;23:1592-1597.

10. Di Pede F, Zuin G, Giada F, et al. Long-term effects of spinal cord stimulation on myocardialischaemia and heart rate variability: Results of a 48-hour ambulatory electrocardiographic monitoring. Ital Heart j 2001;2(9):690-695.

11. Eddicks S, Maier-Hauff K, Schenk M, Muller A, Baumann G, Theres H. 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(5):585-590. [http://dx.doi. org/10.1136/hrt.2006.100784]

12. Ekre O, Eliasson T, Norrsell H, Wahrborg P, Mannheimer C. Electrical stimulation versus coronary artery bypass surgery in severe angina pectoris. 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(24):1938-1945.

13. Hautvast RW, Dejongste Mj, Staal Mj, van Gilst WH, Lie KI. Spinal cord stimulation in chronic intractable angina pectoris: A randomized, controlled efficacy study. Am Heart j 1998;136(6):1114-1120.

14. Jessurun GA, De jongste Mj, Hauttvast RW, et al. Clinical follow-up after cessation of chronic electrical neuromodulation in patients with severe coronary artery disease: A prospective randomized controlled study on putative involvement of sympathetic activity. Pacing Clin Electrophysiol 1999;22(10):1432-1439.

15. Lanza GA, Sestito A, Sgueglia GA, et al. Effect of spinal cord stimulation on spontaneous and stress- induced angina and 'ischemia-like' ST-segment depression in patients with cardiac syndrome X. Eur Heart j 2005;26(10):983-989. [http://dx.doi.org/10.1093/eurheartj/ehi089]

16. Mannheimer C, Eliasson T, Augustinsson LE, et al. Electrical stimulation versus coronary artery bypass surgery in severe angina pectoris: The ESBY study. Circulation 1998;97(12):1157-1163.

17. McNab D, Khan SN, Sharples LD, et al. An open label, single-centre, randomized trial of spinal cord stimulation vs. percutaneous myocardial laser revascularization in patients with refractory angina pectoris: The SPiRiT trial. Eur Heart j 2006;27(9):1048-1053. [http://dx.doi.org/10.1093/eurheartj/ehi827]

18. Norrsell H, Pilhall M, Eliasson T, Mannheimer C. Effects of spinal cord stimulation and coronary artery bypass grafting on myocardial ischaemia and heart rate variability: Further results from the ESBY study. Cardiology 2000;94(1):12-18.

19. Santini. The spinal cord stimulation in ischaemia: Preliminary data [La stimolazione spinale permanente nella cardiopatiaischaemica: Dati preliminary]. Giornale Italiano di Cardiologia 1993;23 (Suppl 1):172.

20. Staal M, de jongste M, Zijlstra G. Spinal cord stimulation for intractable angina pectoris. Acta Neurochir Wien 1992;117:95.

4. CLI

21. Amann W, Berg P, Gersbach P, et al. Spinal cord stimulation in the treatment of non-reconstructable stable critical leg ischaemia: Results of the European Peripheral Vascular Disease Outcomes Study (SCS-EPOS). Eur j Vasc Endovasc Surg 2003;26(3):280-286.

22. Claeys LG, Horsch S. Transcutaneous oxygen pressure as predictive parameter for ulcer healing in endstage vascular patients treated with spinal cord stimulation. Int Angiol 1996;15(4):344-349.

23. Claeys LGV, Horsch S. Effects of spinal cord stimulation on ischaemic inflammatory pain and wound healing in patients with peripheral arterial occlusive disease. Pain Digest 1997;7:200-203.

24. Claeys LGY, Horsch S. Epidural spinal cord stimulation following intravenous prostaglandin E1 therapy in patients with ischaemic pain (peripheral vascular disease Fontaine stage IV). Preliminary results of a controlled randomized study. Pain Clinic 1998;10:165-172.

25. Claeys LGY, Horsch S. Spinal cord stimulation (SCS) following intravenous prostaglandin E1 (PGE1) therapy in non-reconstructible peripheral vascular disease (PVD): Fontaine stage IV. Pain Clinic 1999;11(3):235-243.

26. Jivegard LE, Augustinsson LE, Holm j, Risberg B, Ortenwall P. Effects of spinal cord stimulation (SCS) in patients with inoperable severe lower limb ischaemia: A prospective randomised controlled study. Eur j Vasc Endovasc Surg 1999;9:421-425.

27. Klomp HM, Spincemaille GH, Steyerberg EW, Habbema jD, van Urk H. Spinal-cord stimulation in critical limb ischaemia: A randomised trial. Lancet 1999;353(9158):1040-1044.

28. Spincemaille GH, Klomp HM, Steyerberg EW, Habbema jDF. Pain and quality of life in patients with critical limb ischaemia: Results of a randomized controlled multicentre study on the effect of spinal cord stimulation. Eurj 2000;4(2):173-184. [http://dx.doi.org/10.1053/eujp.2000.0170]

29. Spincemaille GH, Klomp HM, Steyerberg EW, van Urk H, Habbema jD, ESES study group. Technical data and complications of spinal cord stimulation: Data from a randomized trial on critical limb ischaemia. Stereotack Funct Neurosurg 2000;74(2):63-72.

30. Suy R, Gybels j, Van Damme H, Martin D, van Maele R, Delaporte C. In: Horsch S, Claeys L , editors. Spinal Cord Stimulation: An Innovative Method in the Treatment of PVD. Darmstadt: Steinhoff, 1994.

31. Ubbink DT, Spincemaille GH, Prins MH, Reneman RS, jacobs Mj. Microcirculatory investigations to determine the effect of spinal cord stimulation for critical leg ischaemia: The Dutch multicenter randomized controlled trial. j Vasc Surg 1999;30(2):236-244. [http://dx.doi.org/10.1016/S0140-6736(96)02467-1]

5. Diabetic neuropathy

32. Tesfaye S, Watt j, Benbow Sj, Pang KA, Miles j, MacFarlane IA. Electrical spinal-cord stimulation for painful diabetic peripheral neuropathy. Lancet 1996;348(9043):1698-1701.

6. Systematic reviews FBSS and chronic low back pain

33. Mailis-Gagnon A, Furlan AD, Sandoval jA, Taylor R. Spinal cord stimulation for chronic pain (Cochrane Review). In: The Cochrane Library, Issue 3, 2004. Chichester, UK: john Wiley & Sons, Ltd.

34. Taylor RS, Van Buyten jP, Buchser E. Spinal cord stimulation for chronic back and leg pain and failed back surgery syndrome: A systematic review and analysis of prognostic factors. Spine (Phila Pa 1976) 2005;30(1):152-156.

35. Turner jA, Loeser jD, Bell KG. Spinal cord stimulation for chronic low back pain: A systematic literature synthesis. Neurosurgery 1995;37(6):1088-1096.

36. Turner jA, Loeser jD, Deyo RA, Sanders SB. Spinal cord stimulation for patients for failed back surgery syndrome or complex regional pain syndrome: A systematic review of effectiveness and complications. Pain 2004;108(1-2):137-147. [http://dx.doi.org/10.1016/j.pain.2003.12.016]

CLI

37. Ubbink DT, Vermeulen H. Spinal cord stimulation for non-reconstructable chronic critical leg ischaemia (Cochrane Review). In: The Cochrane Library, Issue 4, 2003. Chichester, UK: john Wiley & Sons, Ltd.

CRPS

38. Grabow TS, Tella PK, Raja SN. Spinal cord stimulation for complex regional pain syndrome: An evidence-based medicine review of the literature. Clin j Pain 2003;19(6):371-383.

39. Taylor RS, Van Buyten Pj, Buchser E. Spinal cord stimulation for complex regional pain syndrome: A systematic review of the clinical and cost-effectiveness literature and assessment of prognostic factors. Eur j Pain 2005;10(2):91-101. [http://dx.doi.org/10.1016/j.ejpain.2005.02.004]

40. Turner jA, Loeser jD, Deyo RA, Sanders SB. Spinal cord stimulation for patients for failed back surgery syndrome or complex pain syndrome: A systematic review of effectiveness and complications. Pain 2004;108(1-2):137-147. [http://dx.doi.org/10.1016/j.pain.2003.12.016] Appendix 1 (continued). SCS literature review Cost-effectiveness of SCS (all indications)

41. Simpson EL, Duenas, A, Holmes, MW, Papaioannou, D, Chilcott j. Spinal cord stimulation for chronic pain of neuropathic or ischaemic origin: Systematic review and economic evaluation. Health Technol Assess 2009 13(17):iii,ix-x,1-154. [http://dx.doi.org/10.3310/hta13170]

42. Taylor RS, Taylor Rj, Van Buyten jP, Buchser E, North R, Bayliss S. The cost effectiveness of spinal cord stimulation in the treatment of pain: A systematic review of the literature. j Pain Symptom Manage. 2004;27(4):370-378 [http://dx.doi.org/10.1016/j.jpainsymman.2003.09.009]

7. Further reading

43. Ackroyd RD, Graves jB, McVey j, Horton S. Survey of assessment criteria prior to implantation of spinal cord stimulators in the United Kingdom pain management centres. Eur j Pain 2005:9(1):57-60.

44. De Andres jD, Valia jC, Creda-Olmedo G, et al. Magnetic resonance imaging in patients with spinal neurostimulation systems. Anesthesiology 2007;106(4):779-786. [http://dx.doi.org/10.1097/01.anes.0000264776.17533.06]

45. Beltrutti D, Lamberto A, Barolat G, et al. The psychological assessment of candidates for spinal cord stimulation for chronic pain management. Pain Practice 2004;4(3):204-221. [http://dx.doi.org/10.1 111/j.1533-2500.2004.04305]

46. Cameron T. Safety and efficacy of spinal cord stimulation for the treatment of chronic pain: A 20 year literature review. j Neurosurg 2004;100(3 Suppl Spine):254-267.

47. Cruccu G, Aziz TZ, Garcia-Larrea L, et al. EFNS Guidelines on neurostimulation therapy for neuropathic pain. Eur j Neurol 2007;14(9):952-970. [http://dx.doi.org/10.1111/j.1468-1331.2007.01916]

48. Elkelini MS, Hassouna MM. Safety of MRI at 1.5 Tesla in patients with implanted sacral nerve neurostimulator. Eur Urol 2006;50(2):311-316. [http://dx.doi.org/10.1016/j.eururo.2006.02.011]

49. Heckler DR, Gatchel R, Lou L, Whitworth T, Bernstein D, Stowell AW. Presurgical behavioural medicine evaluation (PBME) for implantable devices for pain management: A 1-year prospective study. Pain Pract 2007;7(2):110-122. [http://dx.doi.org/10.1111/j.1533- 2500.2007.00118.x]

50. Simpson BA (ed). Electrical Stimulation and the Relief of Pain. Pain Research and Clinical Management Vol 15. Amsterdam: Elsevier Science BV, 2003.
Appendix 2. Summary of SCS RCTs

First author
(year; trial
name)             Country          N *    Comparisons

RAP (unresponsive to drug therapy)

Mannheimer        Sweden           104    SCS v. coronary artery
(1998; ESBY)                              bypass surgery

De jongste        Netherlands      17     SCS v. no SCS
(1994)

Hautvast          Netherlands      25     SCS v. no SCS
(1998)

Fiume             Italy            19     SCS v. no SCS
(1994)

FBSS

North             USA              50     SCS v. reoperation

Kumar             Europe/Canada    100    SCS + medical therapy
(2008; PROCESS)                           v. medical therapy
                                          alone

CRPS

Kemler            Netherlands      52     SCS + physical therapy
(2000 & 2004)                             v. physical therapy
                                          alone

Peripheral neuropathy

Testaye           United Kingdom   10     SCS v. no SCS
(1996)                                    (stimulator implanted
                                          but not activated)

CLI

Suy               Belgium          38     SCS v. conservative
(1994)                                    therapy
([section])

Claeys            Germany          86     SCS + PGE1 v.
(1996)                                    conservative treatment
([section])                               + PGE1

jivegard          Sweden           51     SCS + oral analgesics
(1995)                                    v. oral analgesics
                                          alone

Spincemaille      Netherlands      37     SCS + best medical care
(2000)                                    v. best medical care
([section])                               alone

Klomp             Netherlands      120    SCS + conventional
(1999; ESES)                              medical care v.
                                          conventional medical
                                          care alone

Amann             Europe           112    SCS + best medical care
(2003; ECS-EPOS   (multicentre)           v. best medical care
([section]))                              alone

First author
(year; trial      Follow-up                          Results
name)             ([dagger])   Outcomes              ([??])

RAP (unresponsive to drug therapy)

Mannheimer        6 months/    Antianginal           =
(1998; ESBY)      4.8 years    drug intake
                  ([double     Anginal attacks       =
                  dagger])     Exercise capacity     -
                               Quality of life       =
                               Mortality/morbidity   =

De jongste        8 weeks      Exercise capacity     +/=
(1994)                         Physical activity     +
                               Anginal attacks       +
                               Anginal medication    +
                               24-hour ECG           =
                               Ejection fraction     =

Hautvast          6 weeks      Antianginal drugs     +
(1998)                         Anginal attacks       +
                               48-hour ECG           +/=
                               Exercise capacity     +/=
                               Quality of life       =

Fiume             20 weeks     Angina attacks        +
(1994)            ([double     Exercise capacity     =
                  dagger])     24-hour ECG           +

FBSS

North             2.8 years    Pain relief           +
                  ([double     Analgesic use         +
                  dagger])     Activities of
                               daily living
                               Work status
                               Complications

Kumar             6 months     Analgesic use         +/=
(2008; PROCESS)   /2 years     Quality of life       +
                               Satisfaction          +
                               Work status           =
                               Complications         +

CRPS

Kemler            2 years      Pain score            +
(2000 & 2004)                  Functional capacity   =
                               Quality of life       +/=
                               Complications         -

Peripheral neuropathy

Testaye           3 months     Pain score            +
(1996)                         Exercise capacity     +/=
                               Neurophysiological    =
                               indices
                               Metabolic control     =
                               Complications         -

CLI

Suy               20 months    Amputation            =
(1994)            ([double     Fontaine stage        +
([section])       dagger])     Ulcer healing         +
                               Complications         =

Claeys            1 year       Amputation            =
(1996)                         ABPI                  +
([section])                    Fontaine stage        +
                               Ulcer healing         +
                               TcPO2                 +
                               Complications         =

jivegard          18 months    Amputation            +
(1995)                         Pain relief           +/=
                               ABPI                  =
                               Complications         =

Spincemaille      2 years      Amputation            =
(2000)                         Pain relief           +
([section])

Klomp             2 years      Pain score            =
(1999; ESES)      ([double     Tc[PO.sub.2]          -
                  dagger])     Quality of life       =
                               Amputation            =
                               Mortality             =
                               Analgesic use         +/=
                               Complications         =

Amann             18 months    Amputation            +
(2003; ECS-EPOS                Complications         -
([section]))

SCS = spinal cord stimulation; RAP = refractory angina pectoris;
ECG = electrocardiogram; FBSS = failed back surgical syndrome;
CRPS = complex regional pain syndrome; CLI = critical limb
ischaemia; PGE1 = prostaglandin E1; Tc[PO.sub.2] = transcutaneous
oxygen pressure; ABPI = ankle brachial pressure index.

* Number of patients randomised.

([dagger]) Latest follow up reported with groups
  randomisation maintained.

([double dagger]) Mean follow-up.

([section]) Results taken from Cochrane view.

([??]) Results with p<0.05 were considered statistically significant:

+ Improvements in outcome in SCS group v. comparator group at
  follow up (p<0.05).

- Decrement in outcome in SCS group v. comparator group at
  follow up (p<0.05).

= Difference in outcome between SCS group v. comparator group
  at follow up (p>0.05).


DOI: 10.7196/SAMj.6323

A consensus document prepared on behalf of Pain SA in consultation with the South African Spine Society, the Neurological Society of South Africa, and the South African Society of Anaesthesiologists, with guidance from the British Pain Society. These recommendations have been produced by a consensus group (below) of relevant healthcare professionals, and refer to the current body of evidence relating to spinal cord stimulation (SCS).

* Dr M Raff, BSc, MB ChB, FCA (SA): Immediate Past President Pain SA, South African Society of Anaesthesiologists (corresponding author)

* Dr R Melvill, MB ChB, FCS (Neurosurgery) SA: Continental Vice President World Society for Stereotactic and Functional Neurosurgery, Society of Neurosurgeons of South Africa

* Dr G Coetzee, MB ChB, M Med (Neurosurgery): Exco Member of SA Spine Society (Academic affairs), Society of Neurosurgeons of South Africa

* Dr J Smuts, MB ChB, MMed (Neurol), FCN (SA) (by peer review): President Pain SA, Neurological Association of South Africa

Corresponding author: M Raff (raffs@iafrica.com)
Table 1. Types of pain and level of indication for SCS

Level of indication    Type of pain

Good indications       * Neuropathic pain in leg or arm
(likely to respond)    following lumbar or cervical spine
                       surgery (FBSS/FNSS)

                       * CRPS

                       * Neuropathic pain secondary to
                       peripheral nerve damage

                       * Brachial plexopathy: traumatic (partial,
                       not avulsion), post-irradiation

Intermediate           * Amputation pain (stump pain responds
indications            better than phantom pain)
(may respond)
                       * Axial pain following spinal surgery
                       (if there is a neuropathic component
                       accompanying the axial pain)

                       * Intercostal neuralgia, such as post-
                       thoracotomy or post-herpetic neuralgia

                       * Pain associated with spinal cord
                       damage but maintaining posterior
                       column functioning (other peripheral
                       neuropathic pain syndromes, such as
                       those following trauma may respond)

Poor indications       * Central pain of non-spinal cord origin
(rarely respond)
                       * Spinal cord injury with clinically
                       complete loss of posterior column
                       function

                       * Perineal or anorectal pain

Unresponsive           * Complete spinal cord transection

                       * Non-ischaemic nociceptive pain

                       * Nerve root avulsion

FBSS = failed back surgical syndrome; FNSS = failed neck surgical
syndrome; CRPS = complex regional pain syndrome.

Table 2. Medical contraindications to the use of SCS

* Uncontrolled bleeding disorder; ongoing anticoagulant therapy
is a relative contraindication

* Systemic or local sepsis

* Presence of a demand pacemaker or implanted defibrillator
(relative contraindication)

* Immune suppression (relative contraindication)

Table 3. Surgical insertion of electrodes: Special considerations

* General contraindications to surgery should apply, such as
coagulopathy or sepsis

* Surgical electrode systems are larger than percutaneous systems;
to avoid the risk of cord compression, special note must be taken
of the possibility of spinal canal stenosis if the electrodes are to be
inserted beneath intact/residual laminae. Pre-operative MRI of
the target area of the spine should be considered (if not already
performed)

* Extensive laminectomy (particularly in the cervical spine)
has potential morbidity. The appropriateness of further
laminectomy to insert electrodes must be considered
carefully when patients have previously undergone extensive
laminectomy in or adjacent to the target area

* Open insertion of an electrode permits fixation of the electrode
to the dura. If this option is taken, then sutures should

pass through only the outer layer of the dura to avoid the
development of a cerebrospinal fluid (CSF) hygroma

* Approximately 5% of people undergoing thoracic laminectomy
may experience postoperative thoracic backache persisting for
weeks or months. Patients should be warned of this possibility

MRI = magnetic resonance imaging; CSF = cerebrospinal fluid.
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Title Annotation:GUIDELINE
Author:Raff, M.; Melvill, R.; Coetzee, G.; Smuts, J.
Publication:South African Medical Journal
Article Type:Clinical report
Geographic Code:6SOUT
Date:Jun 1, 2013
Words:7119
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