CHAPTER 169 Evidence Base for Destructive Procedures
The surgical treatment of pain has been an integral part of neurosurgery since the early 20th century when Harvey Cushing pioneered ganglionectomy for trigeminal neuralgia (TN). Over the ensuing years as anatomic and physiologic knowledge of pain systems grew, new techniques aimed at new targets were developed for an array of pain conditions.1–4 Targets have included the anterolateral quadrant of the spinal cord, the sensory and sympathetic ganglia, the dorsal and ventral spinal roots, the dorsal root entry zone (DREZ), and decussating extralemniscal fibers, as well as the hypophysis, thalamus, and cingulate gyrus. Careful detailed descriptions of these techniques and their purported efficacy from pioneers in the field established the importance of surgery for the treatment of pain. The invasive nature of these techniques and associated comorbid conditions, as well as the high degree of technical skill required for their use, led to the development and widespread adoption of newer pharmaceuticals and nondestructive treatments. As a result, the use of destructive techniques for the surgical treatment of pain has dramatically declined over the past few decades. They are being or have been replaced with nondestructive techniques, such as spinal cord stimulators and intrathecal opiate pumps, newer medications, and high-dose opiates. However, it is becoming increasingly apparent that none of these techniques are free of their own set of detriments. For example, the chronic administration of opioids is associated with addiction, opioid-induced hyperalgesia, cognitive disorders, high cost, and suppression of the immune and reproductive systems.5,6 Furthermore, it has yet to be proved that the long-term use of opioids improves such outcomes as pain relief, functional capacity, and health-related quality of life.7,8
Neurostimulation and intrathecal drug administration are expensive and require ongoing battery and catheter maintenance and pump refills.9 Despite their widespread use and study, clinical efficacy has not been demonstrated according to modern standards of evidence-based medicine.10
In this chapter we review the published data on destructive procedures for both malignant and nonmalignant pain to determine the degree of evidence supporting continued use and to help define areas that warrant further study. Therefore, we reviewed human clinical studies that reported outcomes for destructive techniques used in the treatment of nonmalignant pain conditions. Reviewed studies were grouped according to the surgical target, beginning with peripheral or “first-order neuron” targets.11
Methods
Our peer-reviewed English literature search paradigm, which encompassed January 1954 to July 2008, was as previously described and applied to both malignant and nonmalignant causes of pain.12
Classification of evidence was based on the hierarchy of clinical research design and the grading system used by the U.S. Preventive Task Force13:
Results
Rhizotomy
Our database search and secondary review of references located 41 rhizotomy studies that in general dealt with spinal or facet pain and facial pain syndromes (
Tables 169-1 to 169-5), and 10 papers that addressed cancer pain (
Table 169-6). The majority of the studies (29/41) reported data relevant to either TN (
Table 169-1, 20 studies14–25,26–33) or lumbar facet syndrome (
Table 169-2, 14 studies34–47), whereas the remainder evaluated the effects of rhizotomy on a variety of truncal and extremity neuralgias (
Table 169-3, 1 study48), cervical pain (
Table 169-4, 9 studies49–57), cluster headaches (
Table 169-5, 3 studies58–60), or cancer pain (
Table 169-6, 10 studies44,61–69) of various causes.
Rhizotomy for Truncal or Extremity Neuralgia and Lumbar Facet Syndrome
Initial success rates were around 60% but declined on long-term follow-up. Despite the variability in treated pain syndromes, number of sectioned roots, outcome measures, and follow-up, the results were sufficiently discouraging that the procedure was relatively abandoned and replaced with modified rhizotomies directed at facet denervation for the treatment of lumbar facet syndrome.44
Four randomized, blinded controlled trials compared RF rhizotomy of the medial branch of the dorsal root with sham treatment (3 studies) or intrafacetal versus extrafacetal rhizotomy (1 study). Outcome measures and patient selection differed sufficiently between the groups to preclude meta-analysis.70 Modest long-term improvement in pain scores in the treated group was observed in all three studies comparing rhizotomy with sham treatment. In the last study, intrafacetal rhizotomy was superior to extrafacetal procedures. Complications were minimal in all four studies. Of the remaining 14 papers, 4 were prospective. The proportion of patients with “good outcomes” varied from 41% to 75% in long-term follow-up. The remaining 7 series are classified as class III studies and reported long-term success rates of 40% to 60% (see 
Table 169-2, 14 studies34–47).
Rhizotomy for Chronic Diskogenic Back Pain
One RCT (see 
Table 169-3) evaluated the effects of RF lesions of the ramus communicans for the treatment of single-level chronic diskogenic back pain.48 All selected patients had previously failed an intradiskal electrothermal procedure and had a good response to local nerve blockade of the ramus communicans. At 1 and 4 months of follow-up, the treated group showed significant improvement in visual analog scale (VAS) scores and the medical outcomes study short-form health survey (MOS 36).
Rhizotomy for Cervical Pain
RF rhizotomy was compared with sham procedures for the treatment of cervical pain or cervicogenic headache in three RCTs.50,56,57 One prospective class II clinical trial51 and four case series also addressed rhizotomy for cervical pain. The number of patients in each RCT was small, ranging from 12 to 24.56 Two of the RCTs demonstrated a significant treatment effect for RF lesions,56,57 although one did not (an underpowered study).50 The class II study also reported durable reduction in validated pain scores.50 Both studies with long-term follow-up demonstrated similar median time to recurrence51,56 (see 
Table 169-4, nine studies49–57).
Rhizotomy for Trigeminal Neuralgia
No controlled trials were found that reviewed the treatment of TN by rhizotomy. The best evidence consisted of two class II and three class III studies that prospectively monitored TN patients treated by RF rhizotomy or glycerol rhizolysis, as well as a large (1600 patients) case series.18 Three studies evaluated pain recurrence rates by life-table analysis,18,30,59 and two of these studies prospectively compared separate cohorts of patients defined by symptomatology21 or treatment protocol.16
Overall, these studies demonstrate a significant long-term benefit from rhizotomy for TN. Reported recurrence rates concurred, 40% to 60% at 5 years. Several authors have suggested that patients with facial pain other than typical or type I TN had higher recurrence rates or poorer patient satisfaction71 (see 
Table 169-1, 20 studies14–25,26–33).
Neurectomy for Trigeminal Neuralgia
Five additional case series involving the treatment of TN were found with the search word “neurectomy” and are summarized in 
Table 169-1.17,22,23,27,33
Rhizotomy and Neurectomy for Cluster Headache and Facial Pain
Two retrospective studies (19 patients)59,60 and one prospective study (18 patients) were reviewed. In the prospective study, 83% of patients had immediate pain relief but also demonstrated a 39% recurrence rate at long-term follow-up58 (see 
Table 169-5, three studies58–60).
Rhizotomy for Cancer Pain
Ten case series were identified and the majority evaluated the effects of dorsal root rhizotomy for malignant pain of the extremities. The largest series contained 71 patients and was one of the earliest papers.44 Reported outcomes were generally favorable initially but faded quickly with time. The open nature of the procedure, the fading effect, and the presence of more effective procedures all contributed to abandonment of this procedure (see 
Table 169-6, 10 studies44,61–69).
Ganglionectomy
A total of 17 articles were found that met the selection criteria indicated earlier. All studies addressed benign pain conditions. Two of these studies were RCTs: one compared RF lumbar ganglionectomy with sham surgery for sciatica,72 and the other compared RF lesions made at two different temperatures.73 The remaining articles were case series ranging in size from 3 to 102 patients (
Table 169-7, 17 studies41,72–87).
Ganglionectomy for Lumbar and Cervical Radicular Pain
Geurts and colleagues in 2003 randomized 83 patients to either RF lesioning (45 patients) or needle placement without RF lesioning (38 patients) of selected lumbar ganglia.72 Evaluators and patients were blinded to the protocol used. Despite adequate power, no statistical difference was found between the groups.
Slappendel and associates in 1997 found no difference in outcomes between patients receiving an RF lesion at 60° C (group I) or 40° C (group II) for cervicobrachialgia.73 In a case series of 61 patients with sciatica,79 59% had “markedly reduced” postoperative pain at follow-up ranging between 1 month and 15 years. Definite conclusions concerning long-term outcomes are difficult given the variability in follow-up data. The remaining studies were small and inconsistent.
Ganglionectomy for Occipital Neuralgia
The largest case series evaluated the efficacy of C2 ganglionectomy for occipital neuralgia.75 These authors found that 80% of patients had significant relief from symptoms. Unfortunately, long-term follow-up data were unclear, thus rendering any conclusions difficult. The second largest series of patients with occipital neuralgia compared ganglionectomy performed on patients with occipital pain described as either “sharp, burning, jabbing, electrical, or exploding” (group I) or “dull, aching, throbbing, or pressure-like” (group II).76 Patients in group I tended to have a higher prevalence of a traumatic history (74%) and had the best response, nearly 80%. Overall, group II patients had a poor response. Follow-up was between 19 and 48 months. Other published series on occipital neuralgia were small and without standardized follow-up data.
One retrospective paper evaluated the effects of occipital neurectomy for the treatment of occipital neuralgia of various causes.87
Ganglionectomy for Other Causes
One study evaluated sphenopalatine ganglionectomy for cluster headache and found that patients with intermittent headache (group A) had a 67% response rate whereas chronic, continuous headache sufferers had only a 24% response.41 Mean follow-up was 24 and 29 months, respectively.
Two small series, one with 4 patients82 and another with 10 patients,86 reported patients treated by thoracic ganglionectomy for a variety of symptoms. Both claimed some success. Ganglionectomy articles are listed in 
Table 169-7 (17 articles41,72–87).
Dorsal Root Entry Zone Lesions
A total of 31 (26 noncancer pain, 5 cancer pain) case series were obtained for DREZ lesions. No class I or II studies were found. These reports included between 3 and 124 patients and had a wide range of follow-up time points. For noncancer pain, all studies reported greater than 50% relief of pain in the majority of patients, and these results tended to be durable.88 Patients with brachial plexus avulsion (BPA) injuries and traumatic spinal cord injury tended to have the best response to DREZ lesions in studies that compared different initial causes directly, whereas patients with postherpetic neuralgia and peripheral neuropathy had the worst response.89,90 Outcomes for patients with BPA injury were quite consistent across series, with 54% to 86% of patients having a greater than 50% reduction in reported pain levels. 
Table 169-8, 26 studies, is a summary of the articles obtained for DREZ lesions.88–113
Only four (
Tables 169-9 and 169-10) papers were identified that addressed the use of DREZ lesions for cancer pain.114–117 Two were case series that claimed long-lasting pain relief in patients with mixed cancer pain causes. Specific follow-up and outcome measures were not reported. For facial pain from craniofacial malignancies, three of the four papers were small case series that reported some benefit from DREZ lesions of the nucleus caudalis.114,116,117
Trigeminal Tractotomy for Facial Pain
Eight pertinent articles were found for tractotomy of noncancer pain, including the oldest article retrieved for this review.118 No class I data were found for this topic. Instead, all papers were case series. The largest case series was reported by Schvarcz in 1975, who found that excellent pain relief was achieved in 16 of 17 patients.119 Interestingly, all case series reported good to excellent results, even in patients with postherpetic neuralgia. In one series, for example, deep pain was eliminated or significantly decreased in 6 of 6 patients with postherpetic craniofacial dysesthesia.120 
Table 169-11, eight case series, presents an overview of the articles just reviewed.118–125
Seven papers were found that involved tractotomy for cancer facial pain (
Table 169-12).119,122,126–130 All were cases series with one exception,126 an open label prospective study. In this prospective class II study, a standardized outcomes measure (VAS), Karnofsky Performance Scale, activities of daily living, and sleep duration were assessed at 6 months. The authors reported sustained relief of pain in 80% of patients at 6 months. Although the study was categorized as class II, the number of tractotomy patients included was limited (10 patients). We did not consider this sufficient to claim class II evidence for the efficacy of tractotomy in relieving facial cancer pain. The current literature supports only class III evidence for tractotomy for cancer pain.
Cordotomy
In general, for studies with long-term follow-up, surgical benefits declined with time. However, determining significance was difficult because neither outcome nor follow-up was standardized for these patients. Furthermore, outcome measures were inconsistent among studies, thus complicating any attempts to make generalized recommendations. The articles that were included in this review are outlined in 
Table 169-13, 11 case series.100,131–140
For cancer pain, cordotomy is the invasive procedure most often reported in the literature. Forty-seven papers qualified under our search criteria (
Table 169-14).65,126,132,134–136,141–181 Many reports included more than 100 patients, many with long-term follow-up. A surge in publications followed the introduction of percutaneous cordotomy in the mid-1960s, followed by a gradual decline in published reports and patients in the late 1990s. Kanpolat introduced CT guidance for percutaneous cordotomy in the late 1980s, which was considered a major contribution to the field of pain surgery. However, intrathecal opioid use was also introduced at around the same time and gained widespread popularity.
One prospective trial was identified; this trial used a standardized outcome measure (VAS), Karnofsky Performance Scale, activities of daily living, and total sleeping hours. This prospective trial reported statistically significant improvement in all outcomes measures with respect to postprocedure and baseline pain levels. Three papers involved retrospective cohorts with survival analysis of pain relief of the whole cohort until death.64,158,159 Many other papers consisted of retrospective cohorts with large numbers (>100 patients) and 6 months’ follow-up.145,153,163,164,179 There were no RCTs.
Myelotomy
Three articles examining the use of myelotomy for noncancer pain were found. They were small case series (3 to 14 patients) with variable follow-up periods and causes of pain. The largest series reported that 64% of patients experienced a complete or marked reduction in deep “background” pain.182 
Table 169-15, three case series, represents a summary of the articles.182–184
For cancer pain, 19 papers were identified (
Table 169-16).124,185–202 These articles were all case series and included papers about commissural as well as extralemniscal myelotomy, both open and percutaneous. With the exception of 3 papers,198–200 most reports involved a small number of patients (<20).
The current literature supports only class III evidence for myelotomy for pain relief.
Mesencephalotomy
Using the criteria described earlier, nine relevant articles on the use of mesencephalotomy for noncancer pain were reviewed. All these articles were case series, and most had relatively small numbers of patients. The most recent publication reported the effects of lesions made in one of two locations in 27 patients with central pain after stroke.203 Long-term pain relief was achieved in 75% of patients with lesions created at the level of the superior colliculus, although significant ocular side effects occurred. These side effects were reduced with lesions adjacent to the inferior colliculus. Long-term pain relief was achieved in 58% of patients in this latter group. Follow-up ranged between 3 months and 5 years. In a separate study, good pain relief was reported in 23 patients (67%) with thalamic syndrome and tabes dorsalis monitored for 3 to 70 months.204 
Table 169-17, nine case series, provides a summary of articles pertaining to mesencephalotomy.203–211
Mesencephalotomy and pontine tractotomy for cancer pain were reported in seven papers (
Tables 169-18 and 169-19).207,212–217 All were case series with variable outcome measures and follow-up. Outcome varied between extreme success (92% until death)215 to very poor success (1 of 12 had lasting pain relief).207 There was agreement on the frequency of side effects, specifically those related to ocular mobility.
Thalamotomy
All published articles describing thalamotomy were limited to small case series with heterogeneous patient populations. Similar to cingulotomy, the largest case series (N = 85) was not published in a peer-reviewed article but in book format218 and was not included here; however, a subset of patients was described earlier.219 Follow-up, outcome measures, target site, and cause of pain were inconsistent within or among series, thus making definite conclusions difficult. Dougherty and associates220 and Tasker221 have provided thorough discussions of thalamotomy. Please refer to 
Table 169-20, 12 case series, for a summary of articles.133,205,219,222–230
Sixteen papers on thalamotomy for cancer pain were found (
Table 169-21)133,205,222,226,229,231–241 (some articles are included in the noncancer pain tables). All were case series with variable outcome measures and follow-up. Most reported lasting benefits in more than 50% of patients. In some instances, bilateral pain relief was achieved with unilateral thalamotomy. Effects tended to fade with time and were often accompanied by persistent psychiatric complications.238
Cingulotomy
A total of 14 original case series focusing on cingulotomy for noncancer pain were found to meet our inclusion criteria as described earlier. Because the largest case series described in the literature (N = 133) was not published as a peer-reviewed article, it was not included in our analysis.242 No class I or class II studies were identified. The largest reviewed case series described 36 patients. Overall, only 2 papers used a validated outcome measure such as the VAS,243,244 and only 2 papers had a common diagnosis for their series.245,246 Follow-up periods were variable, and the majority of the series were published before 1980 (
Table 169-22). Abdelaziz and Cosgrove have provided a detailed description and summary of published case series.247 
Table 169-22, 13 case series, presents a listing of articles pertinent to cingulotomy.205,243,244,246,248–256 Reported case series were small and used variable outcome measures, which made comparisons difficult. For most series, the authors reported variable outcomes.
After elimination of redundancy, seven papers qualified for the criteria of this review and addressed cingulotomy for cancer pain (
Table 169-23).205,244,248,249,254,257,258 All were case series with small numbers and heterogeneous patient selection. In a recent report,244 50% of patients had some pain relief for up to 6 months. Variable results ranging from 10% to 50% were reported in the other papers.
Sympathectomy
A Cochrane review on sympathectomy for nonmalignant pain syndromes, specifically for neuropathic pain syndrome, was located.259 The review criteria that the investigators used included all randomized clinical trials, controlled clinical trials, observational studies (cohorts and case-control studies), and relevant retrospective reviews of patient charts. Only surgical (cervicothoracic or lumbar sympathetic chain ablation or coagulation by open, endoscopic, laser, or RF methods) or chemical (phenol or alcohol solution injected into the cervicothoracic or lumbar sympathetic chain) sympathectomy was included.
For malignant pain our search identified much the same data for noncancer pain. A meta-analysis of neurolytic celiac block (the most common form of sympathectomy performed for cancer pain) was identified.260 Six additional papers (
Table 169-24) were found that addressed either celiac block (published in subsequent years after the meta-analysis data) or other forms of sympathectomy.260–265 These studies generally focused on patients with midline pain from visceral malignancies. The meta-analysis identified two class I “RCTs” demonstrating the efficacy and safety of celiac block for the treatment of pancreatic and upper abdominal visceral malignancies. Of the other five papers, one was a class II “prospective randomized trial” consisting of 65 patients and one was a prospective open label “class II” study with 58 patients. They both demonstrated statistically significant pain relief at 6 months’ follow-up (P < .05) in patients with pancreatic cancer.262,265
Discussion
The few studies that can be classified as class I, in general, are from the anesthesia literature and address percutaneous methods for the treatment of facet or radicular pain.10,13 The results of these studies overall are mixed and highlight the difficulty in extrapolating efficacy from earlier, uncontrolled studies.
In many instances in the neuroablative literature for both malignant and nonmalignant causes of pain, repeated observations have been made across different studies, authors, and institutions that, given their consistency, should be explored further. For example, better outcomes after DREZ lesions were reported for the treatment of patients with BPA injuries than for those with postherpetic neuralgia.89,90 Although the observations were made in uncontrolled studies, expectation and observer bias at least were probably consistent across groups. DREZ lesions may provide considerable benefit to patients with BPA. Denervation pain from BPA has historically been difficult to treat despite the treatment modality.2,88 The efficacy of DREZ lesions for BPA should be studied in a well-controlled and sufficiently powered study. Similarly, consistent beneficial long-term outcomes with similar rates of recurrence of TN treated by rhizotomy have been reported in several large case series.18,21,30 There is strong anecdotal evidence for a significant treatment effect. However, there is still considerable controversy regarding patient selection, timing,71 and its place in light of other efficacious nondestructive treatments such as microvascular decompression.
Important observations have also been made across different treatment modalities and causes that may contribute to a deeper understanding of the underlying pathophysiology of different pain states. Independently, different authors reporting on ablative techniques for the treatment of various causes of pain, ranging from spinal cord injury to TN, have observed that pain described as electrical, intermittent, and stabbing21,30,75,88,100 is more successfully treated by ablative procedures than is pain described as steady or aching, or both. This observation suggests that there may be an underlying difference between these two types of pain that may require distinct interventions.
In designing appropriate modern studies it is crucial to understand that clinical trials for pain treatment are especially prone to such confounders as reporting and observer bias because of the subjective nature of pain and the complete absence of an objective or treatment effect marker.10 The value of validated outcome measures, such as the VAS, as surrogates for more objective measures is now well recognized, and they must be used in modern studies. Care must also be taken to limit such confounders as expectation by the patient and the physician that the treated pain will improve. In fact, it has been well documented that not only do invasive procedures tend to produce a greater placebo effect on patients’ symptoms than do noninvasive treatments but also that these effects decay with time.266 In patients treated for cancer pain, however, this might also represent the limited survival in terminally ill patients and may mask a real therapeutic effect. In addition, different pain states are now known to have different underlying pathophysiologies. Modern studies should not lump all patients together and potentially miss treatable subgroups of patients. However, by identifying subgroups of patients, single centers will have an even harder time maintaining a sufficient volume of a particular procedure to adequately power a valid outcome study. Collaboration across institutions and countries is imperative. Accurate evaluation of surgical pain procedures is a difficult task because of the subjective nature of pain and the additional challenges in blinding patients and evaluators to the procedure being performed. Although sham surgery has been performed in a neurosurgical clinical trial for the treatment of Parkinson’s disease,267 such practice is highly controversial.268 More realistically, it should be recognized that useful and meaningful information can be obtained from well-designed studies that incorporate as many of the elements of a class I study as possible.10,269 Modern observational studies using case controls and modern statistics may still demonstrate treatment effects within the confidence intervals of RCTs.269,270 Important elements include investigator equipoise, blinded or at least impartial evaluators, long follow-up times with intention-to-treat analyses, validated outcome measures, prospective studies with controls, uniform diagnoses, and standardized surgical techniques. With appropriate and well-designed studies, large numbers of patients may not be needed to begin to answer fundamental questions on the surgical treatment of pain.
Finally, it should be noted that the studies reviewed were limited to peer-reviewed journals according to the criteria outlined in our methodology. As eloquently stated by two statesmen in the field “…much information about lesioning surgery in the nervous system for pain relief can be found in textbooks devoted to surgery for pain….”—J. M. Gybels and R. R. Tasker in Wall and Melzack’s Textbook of Pain, fifth edition, 2006.271 For new ideas, read old books (after Pavlov).
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