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Demographic Characteristics of Patients with Severe Neuropathic Pain Secondary to Failed Back Surgery Syndrome

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Demographic Characteristics of Patients with Severe Neuropathic Pain Secondary to Failed Back Surgery Syndrome ORIGINAL ARTICLE Demographic Characteristics of Patients with Severe Neuropathic Pain Secondary to Failed Back Surgery Syndrome Simon Thomson, MBBS, FRCA, FIPP, FFPMRCA*; Line Jacques, MD, FRCSC† *Pain Clinic, Basildon and Thurrock University Hospitals, Basildon, U.K.; †Department of Neurosurgery, Montreal Neurological Institute and Hospital, Montreal, Canada ᭿ Abstract had lower HRQoL. PROCESS patients treatment cost was higher and they commonly took opioids, while antidepres- Background: Neuropathic pain commonly affects the back sants and nonsteroidal anti-inflammatory drugs were more and legs and is associated with severe disability and psycho- often used for other conditions. Prior to baseline, 87% of logical illness. It is unclear how patients with predominantly patients had tried at least 4 different treatment modalities. neuropathic pain due to failed back surgery syndrome (FBSS) Conclusions: Patients suffering from chronic pain of neuro- compare with patients with other chronic pain conditions. pathic origin following FBSS often fail to obtain adequate Aims: To present data on characteristics associated with FBSS relief with conventional therapies (eg, medication, nondrug patients compared with those with complex regional pain therapies) and suffer greater pain and lower HRQoL com- syndrome, rheumatoid and osteoarthritis, and fibromyalgia. pared with patients with other chronic pain conditions. Neu- Methods: The PROCESS (Prospective Randomized Con- ropathic FBSS patients may require alternative and possibly trolled Multicenter Trial of the Effectiveness of Spinal Cord more (cost-) effective treatments, which should be consid- Stimulation, ISRCTN 77527324) trial randomized 100 patients ered earlier in their therapeutic management. ᭿ to spinal cord stimulation (n = 52) plus conventional medical management (CMM) or CMM alone (n = 48). Baseline patient Key Words: patient characteristics, failed back surgery parameters included age, sex, time since last surgery, employ- syndrome, neuropathic pain, quality of life, treatment ment status, pain location and severity (visual analogue pathway scale), health-related quality of life (HRQoL), level of disabil- ity, medication, and nondrug therapies. Reference popula- tion data was drawn from the literature. INTRODUCTION Results: At baseline, patients in the PROCESS study had a A large recent European survey estimated that 19% of similar age and gender profile compared with other condi- adults have moderate to severe chronic pain.1 Many tions. PROCESS patients suffered from greater leg pain and respondents indicated their pain interfered so substan- Address correspondence and reprint requests to: Simon Thomson, ••, tially with their activities of daily living that they could Pain Clinic, Basildon and Thurrock University Hospitals, Basildon, U.K. not maintain an independent lifestyle. Among this group E-mail: [email protected]. are individuals who suffer from neuropathic pain Submitted: December 8, 2008; Accepted: January 18, 2009 DOI. 10.1111/j.1533-2500.2009.00276.x (NeuP). The NeuP arises from peripheral or central nervous © 2009 World Institute of Pain, 1530-7085/09/$15.00 system damage and is typically unresponsive to routine Pain Practice, Volume ••, Issue ••, 2009 ••–•• opioids administered in tolerable doses.2,3 Like most 2•thomson and jacques chronic pain, NeuP is a long-term condition associated of the Effectiveness of Spinal Cord Stimulation, with severe disability, psychological illness, financial ISRCTN 77527324) study, designed to investigate the loss, and social withdrawal.4–10 Lumbosacral pain with effect of spinal cord stimulation (SCS) on neuropathic leg radiculopathy, following nerve injury from a pro- FBSS patients, provided an opportunity to review the lapsed intervertebral disc, is one of the most frequent nature of this condition compared with other chronic causes of NeuP.11–13 Despite the availability of new pain diseases.26,27 This article compares the demo- drugs, pharmacological treatment of NeuP remains graphic characteristics of the PROCESS study patients, unsatisfactory, with less than half of patients achieving including their treatment history, level of pain and significant benefit.14–16 Adequate pain relief may not be quality of life, with published studies of patients achieved in up to 30% of patients who have undergone who have other chronic pain conditions, namely a single back surgery17 and up to 70% of patients who osteoarthritis (OA), rheumatoid arthritis (RA), undergo repeat surgery.18,19 Many patients become complex regional pain syndrome (CRPS), and fibromy- refractory to conventional treatment.20 algia (FM). These conditions are more widely known Conventional patient management of neuropathic and, like FBSS, are considered by several pain back and leg pain secondary to disc herniation includes physicians to be extremely debilitating and life long in surgery. However, when pain persists and no further duration. surgical target exists, the patient is often described as suffering from failed back surgery syndrome (FBSS), METHODS defined as “persistent or recurrent pain, mainly in the The PROCESS study recruited 100 FBSS patients from region of the lower back and legs, even after technically, 12 centers in Europe, Canada, Australia and Israel anatomically successful lumbosacral spine surgeries”.21 between April 2003 and June 2005. The full study inclu- In these patients, NeuP is a principle pain-generating sion and exclusion criteria are published elsewhere.28 In mechanism characterized by predominant leg pain. FBSS summary, eligible patients were at least 18 years of age is common, affecting around 10% to 40% of patients and had NeuP of radicular origin (radiating in der- who have undergone lumbar spinal surgery.11,18,22 matomal segments L4 and/or L5 and/or S1) predomi- The NeuP secondary to FBSS presents a considerable nantly in the legs (exceeding back pain), of a mean challenge to the clinical community. A variety of treat- intensity of at least 50 mm on a visual analogue scale ing disciplines, each with their own disease concepts and (VAS: 0, no pain to 100 mm, worst possible pain) for at treatment preferences, address the multidimensional least 6 months after a minimum of one anatomically needs of patients with refractory neuropathic FBSS. successful surgery for a herniated disc. Management can vary considerably from one physician Each center completed a survey outlining their expe- to another, and from one health economy to another. To rience in treating pain, the use of neuromodulation tech- date no established guidelines describe the best treat- niques (eg, SCS) in the center, and the tools used to ment options. However, a consensus has recently begun diagnose NeuP in the PROCESS study patients. to emerge.23 First, the strong NeuP component of FBSS, Baseline demographic and outcome data were col- suggests that success with further corrective surgery is lected at entry to the study including sex, age, number of unlikely. Second, recent pharmaceutical developments previous surgeries, time since last surgery, employment have improved medical management. Third, the under- status, leg pain location, and severity of back and leg pain standing of the complex impact of prolonged pain on (VAS scale where 0 = no pain and 100 = worst possible both somatosensory and emotional/motivational higher pain). In addition, health-related quality of life was cerebral functioning has spurred multidisciplinary treat- assessed by the Short-Form 36 (SF-3629) and ment approaches. Nevertheless, a proportion of patients EuroQol-5D (EQ-5D30), where a high score represents a with neuropathic FBSS either do not respond to conven- good quality of life. Level of disability measured by the tional management or experience subsequent recurring Oswestry Disability Index (ODI, 0–20: minimal disabil- pain. ity to 80–100: bedbound or exaggerating symptoms31). In a recent review of the literature, it appeared that Drug and nondrug treatments used for pain relief since there is very little demographic data available on FBSS the onset of their FBSS related pain were also recorded. patients: only two reviews were found, which reported Therapies were categorized into seven treatment classes: only gender and age information.24,25 The PROCESS “antineuropathic” medications (eg, antidepressants, (Prospective Randomized Controlled Multicenter Trial anticonvulsants), physical rehabilitation (including phys- iotherapy, occupational therapy, and massage), neuro- stimulation techniques (eg, acupuncture, acupressure, transcutaneous electrical nerve stimulation), psychologi- cal rehabilitation, blocks and injections, nonsteroidal anti-inflammatory drugs (NSAIDs) and opioids. The annual cost of drug therapy was calculated using U.K. and Canadian 2005–2006 national figures. comparativeA structured demographic, literature epidemiological search was used (incidence to identify and prevalence) and drug cost data for 4 chronic, painful conditions, ie, RA, OA, FM, and CRPS, in addi- tion to FBSS. The National Library of Medicine PubMed online database was searched for relevant studies (to February 2008). The detailed search strategy is shown in the Appendix. The abstracts and titles retrieved by these searches were screened by a single reviewer and suitable studies selected for inclusion. Studies were included if (1) they were published in the last 10 years and (2) included relevant information on Demographics of Neuropathic FBSS Patients • 3 the population of patients in one or more of the
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