Patients with neuropathic pain secondary to failed back surgery syndrome (FBSS) typically experience persistent pain, disability, and reduced quality of life. We hypothesised that spinal cord stimulation (SCS) is an effective therapy in addition to conventional medical management (CMM) in this patient population. We randomised 100 FBSS patients with predominant leg pain of neuropathic radicular origin to receive spinal cord stimulation plus conventional medical management (SCS group) or conventional medical management alone (CMM group) for at least 6 months. The primary outcome was the proportion of patients achieving 50% or more pain relief in the legs. Secondary outcomes were improvement in back and leg pain, health-related quality of life, functional capacity, use of pain medication and non-drug pain treatment, level of patient satisfaction, and incidence of complications and adverse effects. Crossover after the 6-months visit was permitted, and all patients were followed up to 1 year. In the intention-to-treat analysis at 6 months, 24 SCS patients (48%) and 4 CMM patients (9%) (p<0.001) achieved the primary outcome. Compared with the CMM group, the SCS group experienced improved leg and back pain relief, quality of life, and functional capacity, as well as greater treatment satisfaction (p<or=0.05 for all comparisons). Between 6 and 12 months, 5 SCS patients crossed to CMM, and 32 CMM patients crossed to SCS. At 12 months, 27 SCS patients (32%) had experienced device-related complications. In selected patients with FBSS, SCS provides better pain relief and improves health-related quality of life and functional capacity compared with CMM alone.

Spinal cord stimulation versus conventional medical management for neuropathic pain: a multicentre randomised controlled trial in patients with failed back surgery syndrome.

Object. The purpose of this report was to examine the available literature to determine the safety and efficacy of spinal cord stimulation (SCS) for the treatment of chronic pain of the trunk and limbs. Methods. The author identified 68 studies that fulfilled the efficacy inclusion/exclusion criteria, grouped on the basis of pain indication, with an overall population of 3679 patients. Fifty-one studies fulfilled all safety inclusion/exclusion criteria. Based on the literature review, the author found that SCS had a positive, symptomatic, long-term effect in cases of refractory angina pain, severe ischemic limb pain secondary to peripheral vascular disease, peripheral neuropathic pain, and chronic low-back pain, and that, in general, SCS was a safe and effective treatment for a variety of chronic neuropathic conditions. Conclusions. Despite the positive findings, there is an urgent need for randomized, controlled, long-term studies on the efficacy of SCS involving larger patient sample sizes.

Safety and efficacy of spinal cord stimulation for the treatment of chronic pain: a 20-year literature review.

Purpose: To compare the validity, reliability and responsiveness of a single, global quality of life question to multi-item scales. Method: Data were obtained from 83 consecutive patients with oesophageal adenocarcinoma undergoing either transhiatal or transthoracic oesophagectomy. Quality of life was measured at baseline, 5 weeks, 3 and 12 months post-operatively with a single-item Visual Analogue Scale (VAS) ranging from 0 to 100, the multi-item Medical Outcomes Study Short Form-20 (MOS SF-20) and Rotterdam Symptom Check-List (RSCL). Convergent and discriminant validity, test–retest reliability and both distribution-based and anchor-based responsiveness were evaluated. Major findings: At baseline and at 5 weeks, the VAS showed high correlations with the MOS SF-20 health perceptions scale (r = 0.70 and 0.72) and moderate to high correlations with all other subscales of the MOS SF-20 and RSCL (r = 0.29–0.70). The test–retest reliability intra-class correlation for the VAS was 0.87. At 5 weeks post-operatively, the distribution-based responsiveness was moderate for the VAS (standardised response mean: −0.47; effect size: −0.56), high for the physical subscales of the MOS SF-20 and RSCL (−1.08 to −1.51) and low for the psychological subscales (0.11 to −0.25). Five weeks post-operatively, anchor-based responsiveness was highest for the VAS (r = 0.54). Conclusion: The VAS is an instrument with good validity, excellent reliability, moderate distribution-based responsiveness and good anchor-based responsiveness compared to multi-item questionnaires. Its use is recommended in clinical trials to assess global quality of life.

/pdf/is-a-single-item-visual-analogue-scale-as-valid-reliable-and-100ghhm6sa.pdf

Is a single-item visual analogue scale as valid, reliable and responsive as multi-item scales in measuring quality of life?

Pharmacological relief of neuropathic pain is often insufficient. Electrical neurostimulation is efficacious in chronic neuropathic pain and other neurological diseases. European Federation of Neurological Societies (EFNS) launched a Task Force to evaluate the evidence for these techniques and to produce relevant recommendations. We searched the literature from 1968 to 2006, looking for neurostimulation in neuropathic pain conditions, and classified the trials according to the EFNS scheme of evidence for therapeutic interventions. Spinal cord stimulation (SCS) is efficacious in failed back surgery syndrome (FBSS) and complex regional pain syndrome (CRPS) type I (level B recommendation). High-frequency transcutaneous electrical nerve stimulation (TENS) may be better than placebo (level C) although worse than electro-acupuncture (level B). One kind of repetitive transcranial magnetic stimulation (rTMS) has transient efficacy in central and peripheral neuropathic pains (level B). Motor cortex stimulation (MCS) is efficacious in central post-stroke and facial pain (level C). Deep brain stimulation (DBS) should only be performed in experienced centres. Evidence for implanted peripheral stimulations is inadequate. TENS and r-TMS are non-invasive and suitable as preliminary or add-on therapies. Further controlled trials are warranted for SCS in conditions other than failed back surgery syndrome and CRPS and for MCS and DBS in general. These chronically implanted techniques provide satisfactory pain relief in many patients, including those resistant to medication or other means.

/pdf/efns-guidelines-on-neurostimulation-therapy-for-neuropathic-25ss0yu4oj.pdf

EFNS guidelines on neurostimulation therapy for neuropathic pain

This guidance document reviews the epidemiology and management of pain in older people via a literature review of published research. The aim of this document is to inform health professionals in any care setting who work with older adults on best practice for the management of pain and to identify where there are gaps in the evidence that require further research. The assessment of pain in older people has not been covered within this guidance and can be found in a separate document (http://www.britishpainsociety.org/pub_professional.htm#assessmentpop). Substantial differences in the population, methods and definitions used in published research makes it difficult to compare across studies and impossible to determine the definitive prevalence of pain in older people. There are inconsistencies within the literature as to whether or not pain increases or decreases in this age group, and whether this is influenced by gender. There is, however, some evidence that the prevalence of pain is higher within residential care settings. The three most common sites of pain in older people are the back; leg/knee or hip and 'other' joints. In common with the working-age population, the attitudes and beliefs of older people influence all aspects of their pain experience. Stoicism is particularly evident within this cohort of people. Evidence from the literature search suggests that paracetamol should be considered as first-line treatment for the management of both acute and persistent pain, particularly that which is of musculoskeletal origin, due to its demonstrated efficacy and good safety profile. There are few absolute contraindications and relative cautions to prescribing paracetamol. It is, however, important that the maximum daily dose (4 g/24 h) is not exceeded. Non-selective non-steroidal anti-inflammatory drugs (NSAIDs) should be used with caution in older people after other safer treatments have not provided sufficient pain relief. The lowest dose should be provided, for the shortest duration. For older adults, an NSAID or cyclooxygenase-2 (COX-2) selective inhibitor should be co-prescribed with a proton pump inhibitor (PPI), and the one with the lowest acquisition cost should be chosen. All older people taking NSAIDs should be routinely monitored for gastrointestinal, renal and cardiovascular side effects, and drug–drug and drug–disease interactions. Opioid therapy may be considered for patients with moderate or severe pain, particularly if the pain is causing functional impairment or is reducing their quality of life. However, this must be individualised and carefully monitored. Opioid side effects including nausea and vomiting should be anticipated and suitable prophylaxis considered. Appropriate laxative therapy, such as the combination of a stool softener and a stimulant laxative, should be prescribed throughout treatment for all older people who are prescribed opioid therapy. Tricyclic antidepressants and anti-epileptic drugs have demonstrated efficacy in several types of neuropathic pain. But, tolerability and adverse effects limit their use in an older population. Intra-articular corticosteroid injections in osteoarthritis of the knee are effective in relieving pain in the short term, with little risk of complications and/or joint damage. Intra-articular hyaluronic acid is effective and free of systemic adverse effects. It should be considered in patients who are intolerant to systemic therapy. Intra-articular hyaluronic acid appears to have a slower onset of action than intra-articular steroids, but the effects seem to last longer. The current evidence for the use of epidural steroid injections in the management of sciatica is conflicting and, until further larger studies become available, no firm recommendations can be made. There is, however, a limited body of evidence to support the use of epidural injections in spinal stenosis. The literature review suggests that assistive devices are widely used and that the ownership of devices increases with age. Such devices enable older people with chronic pain to live in the community. However, they do not necessarily reduce pain and can increase pain if used incorrectly. Increasing activity by way of exercise should be considered. This should involve strengthening, flexibility, endurance and balance, along with a programme of education. Patient preference should be given serious consideration. A number of complementary therapies have been found to have some efficacy among the older population, including acupuncture, transcutaneous electrical nerve stimulation (TENS) and massage. Such approaches can affect pain and anxiety and are worth further investigation. Some psychological approaches have been found to be useful for the older population, including guided imagery, biofeedback training and relaxation. There is also some evidence supporting the use of cognitive behavioural therapy (CBT) among nursing home populations, but of course these approaches require training and time. There are many areas that require further research, including pharmacological management where approaches are often tested in younger populations and then translated across. Prevalence studies need consistency in terms of age, diagnosis and terminology, and further work needs to be done on evaluating non-pharmacological approaches.

Guidance on the management of pain in older people.

Background Chronic reflex sympathetic dystrophy (also called the complex regional pain syndrome) is a painful, disabling disorder for which there is no proven treatment. In observational studies, spinal cord stimulation has reduced the pain associated with the disorder. Methods We performed a randomized trial involving patients who had had reflex sympathetic dystrophy for at least six months. Thirty-six patients were assigned to receive treatment with spinal cord stimulation plus physical therapy, and 18 were assigned to receive physical therapy alone. The spinal cord stimulator was implanted only if a test stimulation was successful. We assessed the intensity of pain (on a visual-analogue scale from 0 cm [no pain] to 10 cm [very severe pain]), the global perceived effect (on a scale from 1 [worst ever] to 7 [best ever]), functional status, and the health-related quality of life. Results The test stimulation of the spinal cord was successful in 24 patients; the other 12 patients did not receive implanted ...

https://www.nejm.org/doi/pdf/10.1056/NEJM200008313430904

Coen P.M. Rijks

Papers

Spinal Cord Stimulation in Patients with Chronic Reflex Sympathetic Dystrophy

Which patients with chronic reflex sympathetic dystrophy are most likely to benefit from physical therapy