Technological advances have provided both patients and surgeons with remarkable improvements for the surgical treatment of lumbar spinal disorders; however, significant portions of patients who undergo surgical repair continue to suffer from chronic low back pain, leg pain, and persistent functional limitations, including lost capacity in activities of daily living (ADL) and a concomitant reduction in quality of life (QoL). Although technical innovations continue, the rate of success of lumbar spine surgery is only marginally better than conventional medical management (CMM) after 1 year and similar to CMM after 2 years.1
Postlumbar laminectomy syndrome, otherwise known as failed back surgery syndrome (FBSS), describes the postsurgical patient population with suboptimal outcomes, such as persistent pain and functional compromise. The incidence of FBSS may be as high as 80,000 cases per year.2 Despite the name, FBSS does not necessarily define a failed surgical procedure; rather, the implication is a technically successful operation that has not been able to produce improved, long-term clinical outcomes. Surgical results may be measured as pain reduction, functional increases, and improvements in QoL or ADLs. Remarkably, the rate of success drops exponentially with each subsequent surgery.3
Factors affecting FBSS may include improper patient selection, unattainable patient expectations, or inappropriate surgical planning during the preoperative stage.4 Complications during the intraoperative stages comprise the majority of suboptimal outcomes leading to FBSS.5,6 FBSS continues to be a significant outcome despite improved surgical techniques, better patient selection, and advances in surgical tools and technology.1
SYNOPSIS OF TREATMENT OPTIONS
FBSS treatments are targeted at the presumptive causes of pain after spinal decompression surgery. This review will focus on treatment options for pain not associated with spinal instability or neural compromise, which, when present, may be appropriate surgical targets. We also avoid discussion of psychosocial comorbidities that likely contribute significantly to diminished postsurgical outcomes. We instead focus on persistent nociceptive and neuropathic pain generators located in the spine in patients who continue to suffer from low back and leg pain, despite a technically successful surgical intervention. In many cases, these pain generators are the same that existed before surgery and can be divided into the anterior, middle, and posterior elements of the spine.7 Anteriorly, for example, the incidence of reherniation following partial discectomy ranges from 5% to 27%.8 Within the cervical spine, adjacent segment disease of surgical magnitude is at least 5.6%.9 In the lumbar spine, that percentage roughly doubles.10 Although effective discogenic pain treatment continues to be elusive, studies are currently underway to explore regeneration of the intradiscal matrix with stem cells to remedy the degenerative process and improve the presenting symptoms.11 Antibiotics have also been used to treat discogenic pain in patients with Modic type I changes for a presumed chronic bacterial infection.12 Further research is necessary to establish these novel techniques as treatment options in the standard of care continuum.
Treatment options for FBSS continue to evolve and may be categorized into five distinct classifications:
- Exercise, physical therapy, and behavioral rehabilitation
- Medication management
- Interventional procedures
- Neuromodulation and implantable technologies
The complex nature of FBSS requires a comprehensive, multi-modal approach, utilizing a multitude of treatment options to optimize outcomes. Several publications have outlined treatment options for FBSS13; however, to our knowledge, there are no publications in the peer-reviewed literature comparing the available levels of evidence for each treatment classification. An evidence-based approach to complex FBSS patients may provide improved outcomes while reducing the cost of treatment by avoiding less effective therapies and their associated risks.
Historically, the approach to FBSS management has been reoperation to ameliorate the painful problem. Thus, surgeons typically managed most FBSS-type pain. Fritsch et al.14 found that reintervention rates following lumbar discectomy from 1965 to 1990 ranged from 5% to 33%. Approximately 34% of the revisions were multiple, and in those patients, epidural fibrosis and instability increased to greater than 60%. A significant cohort of this population, however, had no surgically remediable findings. Due to lack of reasonable surgical options for many patients, conservative measures have gained popularity.
MATERIALS AND METHODS
A literature review was performed in May, 2016, and updated in February, 2017. Searches were conducted of PubMed, Cochrane Library, and bibliographies of relevant English publications on human subjects between 1990 and 2017. Search terms included failed back surgery syndrome, FBSS, postlumbar surgery syndrome, intractable back pain, chronic low back pain, chronic axial back pain, chronic radicular pain, and treatment. Publications were categorized in the order of randomized controlled trials (RCTs), prospective studies, retrospective chart, and systematic reviews. Book chapters, nonsystematic reviews, expert opinions, and case studies were categorically excluded. Study publications selected for inclusion required a minimum of 20 FBSS patients and a minimum of 6-month follow-up.
The search queries returned 2046 articles that were subsequently filtered by title and abstract. Full-text articles for 162 manuscripts were reviewed, of which 41 were deleted due to lack of substantial evidence. The level of evidence for the remaining 121 research papers and systematic reviews were classified on the basis of the stratification criteria adopted by North American Spine Society in 2005 (Figure 1). The highest levels of evidence were tabulated for each treatment category. Due to lack of high levels of evidence for some treatment options, such as medications, expert guidance has been cited and clearly indicated as such.
Exercise, Physical Therapy, Rehabilitation
The evidence for exercise, rehabilitation, manipulation, and behavioral therapy was moderate with no Level I studies in the peer-reviewed literature. There were three Level II studies and one systematic review (Table 1).
In 1994, Timm16 published arguably the strongest level of evidence for exercise and physical therapy. In this Level II RCT, 250 subjects were randomized into five separate groups as follows:
- 1. Physical agents: hot packs, ultrasound, and transcutaneous electrical nerve stimulation (TENS);
- 2. Joint manipulation: manual procedures used to alter the arthrokinematics or the osteokinematics of the lumbar spine;
- 3. Low-tech exercise: flexibility activities, the McKenzie approach, spinal stabilization training, and William flexion exercises;
- 4. High-tech exercise: use of weight machines, free weights, or some form of computerized spinal dynamometer;
- 5. Control group with no exercise program.
Timm and colleagues demonstrated that active forms of exercise are more effective than passive modalities. Physical agents fared no better than the control group, underscoring their lack of efficacy. Joint manipulation, with the exception of lumbar extension, also did not provide any objective efficacy. The active approaches of low and high-tech exercises provided the best results for FBSS patients, with low-tech exercise providing more sustained, cost-effective improvements.
Behavioral modifications, such as mindfulness-based stress reduction (MBSR), have typically shown mixed results. A prospective Level II RCT comparing MBSR with a control group demonstrated statistically significant improvements in QoL parameters.15 The outcome measures included the Roland-Morris Disability Questionnaire, Chronic Pain Acceptance Questionnaire and the visual analog scale (VAS) for pain. Although the sample was small (N = 25), this RCT demonstrated statistically significant benefit for FBSS patients up to 40 weeks. Alternatively, a systematic review of MBSR was inconclusive in terms of pain reduction, but showed some improvement in pain acceptance.18
A systematic review of exercise and rehabilitation after first-time lumbar surgery demonstrated strong evidence for active, intensive exercise within 4 to 6 weeks postoperatively. Furthermore, there was no evidence that such intensive exercise in the immediate postoperative period may increase the incidence of reoperation.19
Literature review yielded only three medication efficacy studies with at least 20 FBSS patients and 6 months or more of follow-up: one Level I study, one Level II study, and one systematic review (Table 2).20–22 Due to the lack of high-quality studies, a subsequent literature review was performed to include Level V expert opinion guidelines23–26 that address pharmacological options frequently prescribed for FBSS:
- Non-steroidal anti-inflammatory drugs (NSAIDs);
- Cyclooxygenase-2 (COX-2) inhibitors;
- Muscle relaxants;
- Opioids (short and long-acting formulations).
Overall, there is scant evidence, at best, on the efficacy of pharmacological options for FBSS. A stronger level of evidence has been demonstrated for medication utilization in nonspecific chronic low-back pain (CLBP) and neuropathic pain models.27–29
A supplemental literature search nonspecific to FBSS identified one systematic review evaluating medication treatments for CLBP29 and two expert guidelines.30,31 Overall, the evidence for the use of medications in FBSS is weak to moderate with the exception of one Level I study. This weak evidence must be contrasted against the burgeoning data surrounding both morbidity and mortality associated with opioids and other medications. As minimal supportive evidence exists, lower levels of evidence, including case reports, have been cited.
Kuijpers et al.29 systematically reviewed 17 RCTs of pharmacological interventions for nonspecific CLBP. Medications included NSAIDs, muscle relaxants, antidepressants, and opioids. All included studies were under 3 months in duration. Kuijpers et al.29 found no studies investigating muscle relaxants in treating CLBP. The authors’ analysis suggests that there is low-quality evidence for both NSAIDs and opioids providing short-term pain relief compared with placebo. Opioids, however, provided a small, short-term improvement of function compared with placebo. Both NSAIDs and opioids were associated with more adverse effects than placebo. The authors found no evidence that antidepressants benefit patients with CLBP.
Kuijpers et al.29 found a low risk of bias in most of the included studies, although they cited methodological weaknesses such as underreported allocation, compliance, and dropout rates. Another possible source of bias cited by the authors is the poor reporting of cointerventions, particularly regarding NSAIDs and antidepressants.29 The available evidence is weak, at best, for the utilization of the several widely applied medications in treating CLBP.
The American Pain Society/American College of Physicians (APS/ACP) expert guideline reported complex benefit-to-harm profiles for medications. There was also insufficient evidence to recommend one medication over another, and limited follow-up times of less than 8 weeks in most studies.30 Despite these limitations, there was good evidence demonstrating efficacy for tricyclic antidepressants, while fair evidence of pain relief with acetaminophen, opioids, tramadol, benzodiazepines, and gabapentin (for radiculopathy) was reported.30
Studies identified in our supplementary literature review included case reports that found gabapentin effective for postoperative epidural fibrosis after spinal surgery32 and a short-term (35 weeks), double-blind RCT that found inconclusive evidence of pregabalin efficacy for neuropathic pain associated with radiculopathy.33
High-quality studies for basic interventional techniques exist, but in limited numbers, including just three Level I studies (Table 3). In addition, 11 Level II studies, two Level III studies, and 10 systematic reviews have been reported. These studies present conflicting data and there is disagreement between systematic reviews.
Level I evidence suggested that caudal epidurals were similar or less expensive than reoperation, manipulation, and medical management.34 In addition, percutaneous adhesiolysis may be more beneficial than epidural steroid injections (ESIs),35 and the use of hyaluronidase was more effective than steroid alone.36
Level II evidence supported epiduroscopy as part of the treatment algorithm.37 Adhesiolysis was demonstrated to be similar to, or less expensive than, CMM, physical therapy manipulation, and reoperation.38 Level II data suggested that adhesiolysis improved disability more than ESIs,39,40 and led to significant long-term relief when compared with ESI.41 Caudal ESI showed long-term pain relief with minimal evidence for addition of steroids.42–44 Endoscopic adhesiolysis with steroid injection was superior to control injection.45 In addition, a two-needle approach for ESI was better than a single-needle approach.46 Interestingly, the combination of selective nerve root blockade and ESI was superior to either injection alone.47 Level II evidence was also found for forceful ESI over normal ESI,48 and epidurography with adhesiolysis was superior to adhesiolysis alone.49
Level III studies supported adhesiolysis for longer-term pain relief over ESI,50 as well as medial branch neurotomy for axial pain.51,52 Systematic reviews supported percutaneous adhesiolyis,53 caudal epidural injections,54 and endoscopic adhesiolysis.55 Systematic reviews also supported caudal epidural injections with limited evidence for transforaminal epidural injections56 and intrathecal drug delivery.57–60 Further studies of systematic review argued fair evidence for percutaneous adhesiolysis61 and caudal epidurals.62 Weak systematic review evidence existed for endoscopic adhesiolysis63 and strong for percutaneous adhesiolysis.64
Several studies have demonstrated advantages of spinal cord stimulation (SCS) over reoperation or CMM (Table 4).65–71 However, only a few are RCTs with strong levels of evidence.72–77 There is even more scant evidence comparing intrathecal drug delivery systems (IDDS) with other management strategies in the treatment of FBSS.78,79
North et al.76,77 were first to demonstrate, in a Level I RCT, that SCS is more effective than repeat surgery for a subpopulation of FBSS patients. All subjects included met criteria for surgical intervention to alleviate nerve root compression. Subjects with indications for immediate reoperation were excluded, such as disabling neurological deficit in the distribution of a compressed nerve root, critical cauda equine compression, or gross spinal instability requiring fusion. This study also demonstrated that SCS was more cost-effective in a 3-year follow-up. Patients were allowed to cross over after 6 months. Significantly more patients in the repeat surgery group crossed over, as compared with the SCS group.76
Similarly, Kumar et al.74,75 reported another Level I RCT that demonstrated SCS was more effective than CMM in reducing pain for FBSS patients, was more cost-effective, and had greater improvement in QoL measures.74,80,81 Historically, SCS has been more successful treating FBSS patients with primary leg pain than back pain.75 The trial-to-implant ratios have been reported in the 44% to 75% range for back and leg pain in patients treated with traditional SCS.82,83
A recent Level I RCT compared the efficacy of traditional, low-frequency SCS with high-frequency SCS at 10 kHz. High-frequency SCS at 10 kHz provided statistically superior reduction of back and leg pain in FBSS patients, with far higher responder rates for leg (83%) and back (85%) pain. Traditional SCS responder rates were 55% and 44% for leg and back pain, respectively.72,73 Responder rate was defined as at least 50% pain relief.
Traditional, low-frequency SCS has limited long-term efficacy for primary back pain in FBSS patients.84 Thus, clinicians have employed IDDS as a viable therapeutic option, before the advent of high-frequency SCS at 10 kHz. Evidence for IDDS treatment is less robust than for SCS, but prospective and retrospective studies examining the efficacy and cost-benefit of IDDS have been published. Kumar et al.78,79 revealed that IDDS was more cost-effective than CMM for patients in chronic pain. Furthermore, Hamza et al.85 reported a Level II study showing significant decrease in pain and an improvement in activity level and mood with IDDS. In addition, Hamza et al.85 and Caraway et al.86 reported 80% to 90% of FBSS patients eliminated chronic systemic opioids with IDDS, reducing the potential side effects from systemic opioids.
Several high-level studies report long-term analgesic benefit maintained for 3 to 5 years for both SCS and IDDS therapy. Time to fiscal neutrality compared with CMM is similar for SCS and IDDS, with 1 to 3 years being the cost inflection point.79,87
Surgical Options and Reoperation
Few studies contain high-level evidence for surgical treatment options, with no Level I data within the peer-reviewed literature. Five level II studies and three Level III studies were identified (Table 5). Notably, four studies investigated preventing FBSS through certain surgical techniques.
The success of FBSS reoperation appears limited. Level I evidence is lacking due to study design and patient recruitment limitations. Two Level II studies showed no significant difference in pain and disability scores on Oswestry Disability Index (ODI) between surgical intervention and conservative options.88,89 Two studies explored different surgical techniques to reduce FBSS, with minimal difference between study group outcomes (VAS, ODI).90,91 Gambardella et al.92 suggest depositing adipose tissue around the nerve root during surgery to prevent recurrent pain and hence reduce FBSS incidence. Level III studies demonstrated that less than 40% of patients found symptomatic pain relief after repeat surgery. Fritsch et al.14 discussed epidural fibrosis as the likely common factor for failed repeat discectomy or decompression, a finding more prevalent with multiple reoperations. North et al.3 reported similar findings with a trend toward improved success in patients who were younger and had minimal scarring postsurgically. To the best of our knowledge, there are no Level II or III evidence publications in the peer-reviewed literature regarding spinal fusion recommendations in the setting of FBSS in order to reduce pain and increase function based on standard validating scoring systems.
Exercise, Physical Therapy, Rehabilitation
Intensive physical therapy and exercise programs are commonly prescribed for FBSS patients. Although the authors agree that physical rehabilitation, in general, may help maintain or increase the patient's functioning, there are only moderate, limited levels of evidence for the long-term outcomes within the peer-reviewed literature. There is no Level I evidence for exercise, physical therapy, and behavioral modification FBSS treatments, but there is strong Level II evidence to support these treatments. On the basis of the demonstrated evidence, the proven, active exercise modalities may be utilized, along with interventional techniques with high levels of evidence, such as SCS, in order to maximize function, reduce medications, and improve the ADLs and QoL. Passive modalities may be avoided due to lack of demonstrated efficacy and associated costs.
There is no “gold standard” for medication treatment of FBSS.23 Although many FBSS patients are treated with medications, data supporting their long-term efficacy are lacking.20–22 Few studies have specifically evaluated FBSS treatment with medications; therefore, pharmacological interventions for CLBP comprise the breadth of the evidence.29–31 Clinicians must weigh adverse events and individual patient responses when selecting specific medications or combinations. Optimization of nonpharmacological treatments may prove to be the best option.23,24,29
Anticonvulsants and antidepressants are frequently recommended for FBSS with a neuropathic pain component,24 despite inconclusive evidence for their efficacy. Gabapentin has shown promise in reducing pain and improving function in case reports; however, high-level follow-up evidence is lacking.32 Furthermore, pregabalin failed to demonstrate greater efficacy than placebo in neuropathic pain associated with radiculopathy.33 Evidence supporting use of antidepressants for neuropathic pain is mixed.29,30
Beyond a case report with unclear clinical implications,93 opioids have not been studied in FBSS. Although fair-to-good evidence supports efficacy for pain relief, lasting functional improvement is uncertain. The risks also include addiction, overdose complications including death, and analgesic failure due to intolerable side effects.26,29,30
Medication management for FBSS is part of an interdisciplinary care model with an emphasis not only on pain control but also on improved function and attention to psychosocial factors.24,26 Nonetheless, there is no Level I or II evidence in support of any such medication utilization for FBSS.
FBSS has many sub-etiologies, often overlapping, so it is difficult to control for confounding factors. Many patients suffer adjacent level disease of either discogenic or facetogenic origin,94 recurrent or persistent neural compressive disease,7 neuritis, fibrosis, deafferentation,14 and hardware pain, not to mention centralization of pain syndromes layered on the bio-psychosocial nature of failed surgeries and disability.25
Interventional pain physicians may observe optimal outcomes for individual patients paired with certain procedures. Those with epidural fibrosis of the lateral recess, for example, may respond dramatically to epidural adhesiolysis directed to that level35,39,40; or those with painful, prognostically positive facet arthrosis at an adjacent level may be resoundingly treated with denervation of those facet joints.52 Interventions aimed at a specific and responsible sub-etiology of the syndrome often work similarly to the effects seen in non-postoperative patients. Although short-term positive impacts on VAS and ODI have been shown, many studies have limited follow-up and cannot establish long-term efficacy.
Improvements in imaging resolution and understanding the correlation with prognostic indicators will likely generate more robust studies. Sweeping claims about treatment efficacy are hard to make due to the heterogeneity of the FBSS pain etiology. Therefore, sound clinical evaluation with particular sensitivity to the nuances of patient histories will best guide treatment options. Some data exist supporting interventions such as ESIs (Level I),34 lysis of epidural fibrosis (Level I),35 and radiofrequency rhizotomy (Level III)51 to treat the appropriate FBSS patient. Long-term therapeutic evidence for any and all such interventions continues to be limited.
Neuromodulation, including SCS and IDDS, may offer more effective, safer long-term pain management for FBSS patients, especially in light of the recent call by The Centers for Disease Control and Prevention (CDC) to lessen dependence on chronic opioid therapy for chronic pain.95 As SCS has fewer complications and no medication-related side effects,83 it is usually the preferred over IDDS; however, both may be more effective than systemic medications.74,75,85,86 A significant advantage of both SCS and IDDS is the option to trial the therapy for several days with a simple percutaneous needle delivery of electrodes (SCS) or a catheter (IDDS) before undertaking a permanent implant.
The strongest evidence for FBSS treatment with implantable technology exists for SCS. Recent Level I data demonstrated robust results for high-frequency SCS at 10 kHz.72,73 High-frequency SCS at 10 kHz resulted in superior pain relief compared with traditional SCS, and demonstrated long-term efficacy up to 24 months.96,97
When SCS does not provide adequate relief and systemic medications lack efficacy or cause intolerable side effects, IDDS may be effective by placing low doses of medication directly at the spinal target of interest (Level II).78,98,99
Of course, as with all therapies, not every patient diagnosed with FBSS and noncorrective lesion is a candidate for implantable technologies. The authors encourage the astute clinician to weigh all evidence available along with a comprehensive evaluation of the specific FBSS patient, in order to choose the best therapeutic modality.
Surgical Options and Reoperation
Ultimately, there is a lack of evidence for an obvious surgical reoperative technique that reliably treats FBSS patients. Reoperation is likely to be considered when there is an obvious concordant anatomical and clinical source for symptoms, and fusion is likely to be considered when there may be obvious signs of spinal instability and/or acute nerve root compromise unresponsive to more conservative interventions. Some patients will likely benefit from reoperation, but there is no sufficiently high-level evidence to identify such surgical candidates. As always, astute, educated clinical judgment must determine surgical versus nonsurgical treatment decisions, as well as consider evidence-based alternatives, such as neuromodulation.
In 1999, Krames et al. proposed that neuromodulation therapies be added as the final step on the analgesic stepladder algorithm initially proposed by the World Health Organization (WHO).100–102 More recently, Krames et al.103,104 proposed abandoning the stepladder approach in favor of a more holistic algorithm that accounts for multiple individual factors with the acronym S.A.F.E., in order to compare the Safety, Appropriateness, Fiscal neutrality, and Effectiveness of different treatment options. We propose that before the implementation of any therapeutic option, all patients have a comprehensive evaluation to assess treatment options in the context of the S.A.F.E. principles where the most effective, safe, appropriate, and fiscally neutral therapy is implemented.
Although our extensive literature search for the treatment options for FBSS has resulted in a number of potential therapeutic choices, the strongest, long-term Level of evidence is for SCS, specifically high-frequency SCS at 10 kHz. Substantial Level II evidence also exists for traditional SCS and IDDS. Active exercise and rehabilitation have also demonstrated robust, Level II evidence with long-term efficacy for their utilization in the FBSS patient population. Moreover, specific interventional procedures have demonstrated strong Level I and II evidence up to 1 year. The weakest level of evidence was found for medications and reoperation, demonstrating their general lack of efficacy in FBSS. The results of this evidence-based approach to the treatment options for FBSS underscore the need for further research and development of better, and longer term, therapeutic options for such patients. However, for the time being, therapeutic options with the strongest, long-term evidence should be considered in for the appropriate FBSS patient.Key PointsClinicians may better treat Failed Back Surgery Syndrome (FBSS) patients armed with the level of evidence available for all therapeutic options.The weakest level of evidence for the treatment of FBSS is in medication management and reoperation.The strongest level of evidence is in active exercise, some interventional procedures, and spinal cord stimulation (SCS).A novel form of SCS, high-frequency SCS at 10 kHz, was shown to be superior to traditional, low-frequency SCS in a Level I RCT in the treatment of FBSS.Treating the FBSS patient with the levels of evidence in mind will likely render the best outcomes with potentially reduced treatment costs.
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