ORIGINAL ARTICLE

Clinical Effectiveness of Percutaneous Adhesiolysis Versus Transforaminal Epidural Steroid Injection in Patients With Postlumbar Surgery Syndrome Jung Hwan Lee, MD, PhD,* and Sang-Ho Lee, MD, PhD† Background and Objectives: A number of patients with postlumbar surgery syndrome (PLSS) do not experience satisfactory results after epidural injection. A main reason for failure is surgically induced perineural fibrosis impeding injected material from spreading effectively into the target area. Percutaneous adhesiolysis (PA) has the ability to eliminate the deleterious effects of such adhesions. This study was to evaluate the effectiveness of PA versus transforaminal epidural steroid injection (TFESI) for treating patients with PLSS and to compare the clinical efficacy of PA according to the type of surgery. Methods: This retrospective study included 114 patients who underwent PA or TFESI for chronic pain of at least 3 months duration; all of the patients had undergone lumbar surgery at least 6 months before. For each group, we compared the Numeric Rating Scales for back pain (NRS back) and leg pain (NRS leg) and the Oswestry Disability Index (ODI) before surgery and then 2 weeks and 6 months after surgery. In addition, we divided the PA group into decompression and fusion surgery subgroups, comparing the clinical scores in the 2 subgroups. Results: The proportion of successful results was higher for the PA group than for the TFESI group according to 6-month posttreatment NRS back, NRS leg, and ODI scores. Within the PA group, the proportion of successful results was significantly higher in the decompression subgroup than in the fusion group according to 6-month posttreatment NRS leg and ODI scores. Conclusions: Percutaneous adhesiolysis was more effective than TFESI in treating patients with PLSS and also showed better clinical efficacy in the decompression subgroup than in the fusion subgroup. (Reg Anesth Pain Med 2014;39: 214–218)

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ostlumbar surgery syndrome (PLSS) (failed-back surgery syndrome of the lumbosacral spine) is characterized by persistent pain in the lower back or lower extremities after surgical treatment of a benign spinal pain condition. Postlumbar surgery syndrome is hypothesized to occur secondary to multiple causes, including epidural fibrosis, acquired stenosis, recurrent disc herniation, sacroiliac joint pain, or facet joint pain.1 Epidural or perineural fibrosis is considered the main causal factor and is reportedly responsible for approximately 20% to 36% of cases of PLSS.2,3 Postlumbar surgery syndrome that responds poorly to conservative management, including physical therapy and medication, is often treated with epidural steroid injections.1 However, From the *Department of Physical Medicine and Rehabilitation, and †Department of Neurosurgery, Wooridul Spine Hospital, Seoul, Korea. Accepted for publication February 10, 2014. Address correspondence to: Jung Hwan Lee, MD, PhD, Department of Physical Medicine and Rehabilitation, Wooridul Spine Hospital, 46-17 Chungdam-Dong, Gangnam-Gu, Seoul, Korea (e‐mail: [email protected]). The authors declare no conflict of interest. This study was supported by Wooridul Spine Foundation. Copyright © 2014 by American Society of Regional Anesthesia and Pain Medicine ISSN: 1098-7339 DOI: 10.1097/AAP.0000000000000073

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epidural steroid injection, even via a transforaminal approach, frequently produces disappointing results. A main reason for failure is surgically induced perineural fibrosis impeding injected material from spreading effectively into the target area.4 Percutaneous adhesiolysis (PA), a minimally invasive therapy, may be a useful treatment method in patients with chronic pain refractory to conservative treatments.5 The PA catheter enters the ventral epidural space directly, advancing along the ventral epidural space (lateral recess to foramen) and directly breaking up perineural/epidural adhesions, fibrosis, or resistive areas that are physical barriers to penetration of perineurally deposited drugs. Conversely, the epidural needle is placed near the foramen and delivers agents into the ventral epidural space through the foramen. Injection alone cannot lyse adhesions or fibrosis. Percutaneous adhesiolysis may enhance the delivery of high concentrations of injected drugs to the target area and overcomes the limitations of epidural injection.6,7 This property of PA may provide clinical benefit in patients who fail to respond to conservative treatment, including epidural injections.8 Although PA has been identified as clinically efficacious in patients with PLSS,6,9–11 only 2 studies have compared the clinical outcomes of PA with those of epidural injection, and both examined only caudal injection.12,13 However, transforaminal epidural steroid injection (TFESI) is the most favored method of epidural steroid injection, as it delivers injected substances into ventral epidural space directly.14 Therefore, a study comparing PA with TFESI is indicated and may provide clinically useful information. The surgical procedures performed on the lumbar spine were divided broadly into decompression and fusion surgeries. We were unable to find previous studies comparing the clinical efficacy of PA between 2 different surgical techniques. An assessment of the clinical outcomes of PA in patients who underwent surgery by 2 different techniques, such as fusion and decompression, could provide the physician with useful information with which to plan treatment and predict outcome after PA in patients with PLSS. The main purpose of this study was to compare the effectiveness of PA and TFESI for managing chronic lower back and leg pain in patients with PLSS. The secondary purpose was to compare the clinical efficacy of PA according to the surgical technique, such as decompression or fusion surgery, that preceded the PLSS. We hypothesized that PA would offer superior outcomes as compared with TFESI in these study populations.

METHODS Subjects This retrospective study was approved by the institutional review board of our hospital. We selected patients older than 18 years who had undergone PA or TFESI from 2009 to 2012, for the treatment of chronic lower back and lower extremity pain of at least 3 months’ duration after lumbar surgery performed

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a minimum of 6 months before the procedure. Only patients who had not responded to conservative management, including medication and physical therapy performed for at least 1 month, were included. We selected those 174 patients who had open lumbar discectomy or fusion surgery at 1 level and excluded those who received minimal invasive surgeries such as endoscopic discectomy or annuloplasty. We selected patients with 1-level surgeries, as the amount of injectate was larger and adhesiolysis was more extensively conducted in multiple-level surgery than in 1-level surgery, potentially affecting the results of this study. The exclusion criteria included a diagnosis of sacroiliac joint or facet joint pain based on clinical or radiological evaluation, psychiatric disorders, neurological deficits, and laboratory results suggesting bleeding disorders, infection, inflammatory disease, or rheumatoid disorders. We also excluded patients who had undergone 2 or more lumbar surgeries, given that repetitive insults to soft tissue from repeated surgeries could lead to poor surgical outcomes.15 In addition, there might be cases of misdiagnosis or inappropriate surgery among patients with multiple surgeries, which we intended to rule out. Of 172 patients, 58 were excluded based on exclusion criteria, leaving 52 patients in the PA group and 62 patients in the TFESI group in this study.

Data Collection We obtained demographic and clinical data including the patient’s age, sex, site of leg pain (right, left, or both), surgical level, the time interval from surgery to PA or TFESI, and the duration of symptoms as well as clinical evaluation data including the Numeric Rating Scale (NRS) and the Korean version of Oswestry Disability Index (ODI) scores. We also collected data regarding surgical technique, including decompression or fusion surgery. In the PA group, 38 had undergone decompression surgery and 14 fusion surgery; in the TFESI group, 45 had undergone decompression surgery and 17 fusion surgery. The NRS scores for back pain (NRS back) and leg pain (NRS leg) as well as the Korean version of the ODI were used to evaluate the clinical effectiveness of the treatment in terms of pain reduction and functional improvement. These were recorded before treatment, 2 weeks after treatment, and 6 months after treatment. All patients were asked to report the average severity of their symptoms over the previous 1-week period. On the NRS, a score of 0 represents no pain and a score of 10 represents the worst pain imaginable. Functional assessment was performed using the Korean version of the ODI with a scale from 0 to 50. The ODI (%) was calculated using the scores provided by each patient. For example, if a patient’s total score from the 10 sections was 16, then that patient’s score would be 32% (16/50 [maximal possible score]  100). The value and validity of the NRS and the Korean version of the ODI have been reported previously.16 Successful pain relief was described as a reduction in the NRS score of 50% or more, and successful functional improvement was defined as a reduction in the ODI of 40% or more.12 The NRS scores and ODI (%) were compared between the PA and TFESI groups to determine the clinical efficacy of PA in comparison with that of TFESI. In addition, we compared the NRS scores and ODI (%) between the decompression and fusion subgroups of the PA group to determine how the clinical efficacy of PA for treatment of PLSS differed between these 2 surgical techniques.

Percutaneous Adhesiolysis Percutaneous adhesiolysis was performed under fluoroscopy in a sterile operating room with equipment for monitoring blood pressure, pulse rate, and pulse oximetry. The fluoroscope © 2014 American Society of Regional Anesthesia and Pain Medicine

Adhesiolysis in PLSS

was adjusted over the lumbosacral area so that the caudal approach could be visualized in both the anteroposterior and lateral views. After the fluoroscope was appropriately positioned, the area for needle insertion around the sacral hiatus was determined and infiltrated with local anesthetic. A tiny incision was made at the needle insertion area, and a 15-gauge Tuohy needle with an introducer was inserted through the sacral hiatus into the epidural space. Approximately 2 to 5 mL of contrast medium was injected to confirm that the needle was placed in the epidural space and to avoid intravascular or subarachnoid needle placement, and then an epidurogram was performed. The Tuohy needled was removed, a NaviCath (Myelotec Inc, Roswell, Georgia) was passed through the introducer under fluoroscopic visualization and intermittent lateral fluoroscopic views were obtained to make sure the catheter was advanced along the ventral epidural space. At least 5 mL of contrast medium was injected to identify filling defects by examining the flow of contrast into the nerve roots. The catheter was positioned near the filling defect and the area suspected of being the source of pain. Then, adhesiolysis and decompression were performed both by distension with normal saline and mechanically using the catheter. Some patients indicated that they felt pain similar to that which they had been experiencing when the catheter was placed in an area suspected to be the source of pain. After adhesiolysis, contrast medium was injected to confirm that satisfactory filling was obtained epidurally and at the targeted nerve root without subarachnoid or intravascular flow. The catheter was advanced along bilateral lateral recess zones and neural foramens and a mixture of 2 mL of 0.5% lidocaine and 3.5 mg of betamethasone was slowly injected at each side. Catheterization and injections of medications were basically conducted bilaterally at the surgical level because even if the patients with unilateral leg symptom experienced axial back pain, usually manifested as central, bilateral, or contralateral pain to leg pain side. After completion of the procedure, a sterile dressing was applied to the sacral hiatus. Then, the patient was placed in the supine position and transferred to the recovery room. In the recovery room, the patient was monitored very closely for any potential complications or adverse effects.

Transforaminal Epidural Steroid Injection For TFESI, the patient was placed in the prone position, and the fluoroscopic tube was rotated obliquely to an ipsilateral oblique angle with respect to the nerve root suspected of being the source of pain. The goal of this positioning was to allow a perpendicular needle track toward the classic injection site underneath the pedicle in the so-called safe triangle, which is defined by the pedicle superiorly, the lateral border of the vertebral body laterally, and the outer margin of the spinal nerve medially.17,18 Under fluoroscopic guidance, a 12-cm, 21-gauge spinal needle was advanced into the safe triangle. The needle position was checked on the anterior-posterior and lateral fluoroscopic views. Approximately 1 mL of contrast medium was then injected. Anterior-posterior and lateral views were obtained to confirm the distribution of the contrast medium. Transforaminal epidural steroid injection was performed bilaterally and a combination of 2 mL of lidocaine (0.5%) and 3.5 mg of betamethasone was slowly injected at each side.

Same Size Calculation Sample size was calculated based on previous literature reporting the proportion of successful outcomes at 6 months after TFESI in patients with PLSS. Approximately 26% of patients reported good response at 6 months after treatment.4 At least a 20% difference of proportion was assumed to be clinically

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TABLE 1. Comparison of General Characteristics Between PA and TFESI Before Treatment

Age, y Sex ratio (male/female) Site of leg pain (right/left/both) Surgical techniques (fusion/decompression) Surgical level (L3-4/L4-5/L5-S1) Duration from surgery to procedure, mo Duration of symptom, mo NRS back at pretreatment NRS leg at pretreatment ODI at pretreatment

PA (n = 52)

TFESI (n = 62)

P

56.4 (11.3) 28/24 25/20/7 14/38 5/32/15 39.6 (36.3) 23.6 (25.3) 6.4 (1.6) 7.0 (1.4) 51.6 (17.1)

59.2 (13.4) 27/35 24/30/8 17/45 8/31/23 36.6 (25.3) 25.6 (28.7) 6.4 (1.8) 7.0 (1.6) 46.9 (19)

0.240 0.347 0.570 1.000 0.465 0.616 0.693 0.986 0.955 0.167

Values are mean (SD).

meaningful. Considering a 0.05 two-sided significance level, a power of 80%, and an allocation ratio of 1:1, 50 patients in each group were required.

Statistical Analysis The Student t test or Mann-Whitney test were used to compare age and the pretreatment NRS back, NRS leg, and ODI scores between the PA and TFESI groups as well as between the decompression and fusion subgroups. The χ2 and Fisher exact tests were used to determine whether the proportions of successful results according to the 2-week and 6-month posttreatment NRS back, NRS leg, and ODI scores differed significantly between the PA and TFESI groups as well as between the decompression and fusion subgroups. All statistical analyses were performed using the SPSS version 12.0 statistical package. The results were considered statistically significant when the P value was less than 0.05.

RESULTS The patients’ ages, sex ratios, leg pain side, surgical levels, and pretreatment NRS back, NRS leg, and ODI (%) scores did not differ significantly between the PA and TFESI groups before treatment (Table 1). Of the 52 patients in the PA group, 34 (65.4%), 34 (65.4%), and 33 (63.5%) patients achieved successful outcomes according to their 2-week posttreatment NRS back, NRS leg, and ODI scores, respectively. Among the 62 patients in the TFESI group, 33 (53.2%), 40 (64.5%), and 31 (50%) patients achieved successful outcomes according to their 2-week posttreatment NRS back, NRS leg, and ODI scores, respectively. The 2-week posttreatment NRS back, NRS leg, and ODI scores did not differ significantly between the groups. Six months after treatment, the PA group exhibited a significantly higher proportion of successful results than the TFESI group according to their NRS back [29 (55.8%) vs 21 (33.9%)], NRS leg [28 (53.8%) vs 19 (30.6%)], and ODI [31 (59.6%) vs 18 (29%)] scores (Fig. 1). Age, sex ratio, leg pain side, surgical levels, and pretreatment NRS back, NRS leg, and ODI (%) scores did not differ significantly between the decompression and fusion surgery groups before treatment (Table 2). The decompression group demonstrated a significantly larger proportion of successful results than the fusion group according to their 6-month posttreatment NRS leg [25 (65.7%) vs 3 (21.4%)] and 6-month posttreatment ODI [26 (68.4%) vs 4 (28.6%)] scores (Fig. 2).

DISCUSSION Treatment of patients with PLSS is challenging because epidural or perineural fibrosis, a main causal factor of PLSS,

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interferes with various treatment approaches. Epidural fibrosis after surgery is produced by postoperative hematoma formation and leakage of the proinflammatory mediators of the nucleus pulposus into the epidural space.19,20 Fibrosis or tissue adhesions around the nerve root can reduce the vascularization of the nerve, lead to mechanical tethering of the nerve roots and irritation of the exposed dorsal root ganglion, or increase the susceptibility of the nerve root to tension or compression.4,20 Epidural steroid injection is commonly performed to manage PLSS.21–23 However, only a moderate proportion of patients receiving epidural steroid injection experience pain reduction and functional improvement.22,23 One study examining the spread of contrast under fluoroscopic guidance found that despite accurate placement of the needle in the epidural space, the contrast medium successfully spread to the target area in only 26% of cases. The explanation for this was that fluid usually spreads to areas of low resistance and that surgically induced perineural fibrosis or adhesions in the PLSS distorted the normal anatomy and prevented appropriate distribution of the contrast medium within the epidural space.24

FIGURE 1. PA obtained significantly higher proportion of successful outcomes than TFESI according to 6-month NRS, back, leg, and ODI. NRS back indicates Numeric Rating Scale for back pain; NRS leg, Numeric Rating Scale for leg pain. *P < 0.05. © 2014 American Society of Regional Anesthesia and Pain Medicine

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Adhesiolysis in PLSS

TABLE 2. Comparison of General Characteristics Between Decompression and Fusion Surgery Groups Before Treatment

Age, y Sex ratio (male/female) Site of leg pain (right/left/both) Surgical level (L3-4/L4-5/L5-S1) Duration from surgery to procedure, mo Duration of symptom, mo NRS back at pretreatment NRS leg at pretreatment ODI at pretreatment

Decompression (n = 38)

Fusion (n = 14)

P

55.1 (11.9) 20/18 20/15/3 3/25/10 40.2 (35.6) 21.0 (22.3) 6.1 (1.5) 7.0 (1.4) 50.7 (16.5)

60.1 (8.5) 8/6 5/5/4 2/7/5 38.2 (39.7) 30.6 (32.0) 7.0 (1.5) 7.1 (1.4) 54.1 (18.9)

0.156 1.000 0.142 0.566 0.863 0.225 0.075 0.829 0.526

Values are mean (SD). *P < 0.05.

The literature concerning the clinical efficacy of PA in patients with PLSS shows moderate to strong evidence that this technique is effective for managing pain due to PLSS.6,7,9–11 However, only 2 case-control studies have compared the clinical efficacy of PA with that of epidural steroid injection, and both of these examined caudal approaches.12,13 One comparative study found that the PA group had achieved significantly better pain relief and functional improvement (73%) than the caudal epidural steroid injection group (12%) 1 year after treatment.12 The other such study also showed a significant advantage for PA, with pain relief and functional improvement in 83% of the PA group versus 5% of the caudal injection group 2 years after treatment.13 Despite their longer follow-up periods, both of these studies showed better clinical effectiveness of PA than did our results. This discrepancy might be due to repetition of the treatment during the follow-up period. The results of these 2 studies suggest that the removal of epidural adhesions by PA and the subsequent enabling of appropriate delivery of medication to the targeted area produce clinical outcomes superior to those of caudal injection. Our study showed that the clinical benefits of PA are also superior to those of TFESI, which has been believed to deliver medication to targeted areas more effectively than caudal or interlaminar injections.14 Percutaneous adhesiolysis was less clinically effective in the fusion group than in the decompression group. This could be explained by several hypotheses. First, the patients who had undergone fusion surgery were more likely to have had more severe spinal problems even before surgery than those who had undergone decompression. In particular, fusion surgeries were usually indicated for patients with instability. If fusion were inappropriate or insufficient to maintain stability even in the absence of pseudoarthrosis or nonunion, then a nonsurgical treatment such as PA would be unable to improve the patient’s status. Fritsch et al25 noted that epidural fibrosis resulting from chronic irritation due to segmental instability could be resolved by spinal fusion but not by PA. Second, fusion surgery was generally more extensive than decompression; therefore, fusion surgery was more likely to cause the perineural hematoma formation and leakage of nucleus material that are the main causes of epineural fibrosis, as well as neural injury and paraspinal muscle damage, than was decompression.15 Third, the cages or screws that were inserted for fusion surgery had the potential to increase the severity of the epidural or perineural fibrosis beyond that caused by decompression, which might also make it more difficult to advance the catheter to the target area accurately. We did not exclude patients with adjacent segment syndrome or pseudoarthrosis in advance because © 2014 American Society of Regional Anesthesia and Pain Medicine

this study was conducted retrospectively. However, no patient with significant adjacent segment syndrome or pseudoarthrosis as evidenced by dynamic simple radiography after fusion surgery was included in this study because such patients usually underwent another surgical treatment rather than PA. Therefore, the poorer outcomes of fusion surgery were not influenced by the presence of significant adjacent segment syndrome or pseudoarthrosis. Although there were various subtypes in decompression or fusion surgery, we did not assess the clinical outcomes according to subtypes because there had been no report suggesting that treatment outcomes would be affected by differences of subtypes; in addition, we did not have an adequate number of study participants to divide into subgroups. This study has certain limitations. First, the 6-month followup period was relatively short. However, because the procedure was not repeated during the follow-up period, our results reflect the clinical efficacy of a single treatment and exclude the influences of repetition and the cumulative effects of multiple procedures. Second, this study was retrospective in design. Although we selected the

FIGURE 2. Decompression obtained significantly higher proportion of successful outcomes than fusion according to 6-month NRS leg and ODI. NRS back indicates Numeric Rating Scale for back pain; NRS leg, Numeric Rating Scale for leg pain. *P < 0.05.

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subjects using the extensive inclusion and exclusion criteria described in the Methods section, there could have been heterogeneity among the subjects included in this study. In addition, we could not exclude other treatments such as medication or physical therapy during follow-up periods entirely. It was expected, however, that these treatments had nearly no or minimal effects on results because the patients refractory to these treatments were included in this study. In conclusion, this study suggests that PA is more effective than TFESI for pain reduction and functional improvement in patients with PLSS. Percutaneous adhesiolysis also achieved better clinical efficacy in the decompression subgroup than in the fusion subgroup. REFERENCES 1. Shah RV, Merritt W, Collins D, Racz GB. Targeting the spinal nerve via a double-needle, transforaminal approach in failed back surgery syndrome: demonstration of a technique. Pain Physician. 2004;7:93–97. 2. Epter RS, Helm S2nd, Hayek SM, Benyamin RM, Smith HS, Abdi S. Systematic review of percutaneous adhesiolysis and management of chronic low back pain in post lumbar surgery syndrome. Pain Physician. 2009;12:361–378. 3. Ross JS, Robertson JT, Fredrickson RC, et al. Association between peridural scar and recurrent radicular pain after lumbar discectomy: magnetic resonance evaluation. Neurosurgery. 1996;38:855–861. 4. Devulder J, Deene P, De Laat M, Van Bastelaere M, Brusselmans G, Rolly G. Nerve root sleeve injections in patients with failed back surgery syndrome: a comparison of three solutions. Clin J Pain. 1999;15:132–135. 5. Manchikanti L, Singh V, Bakhit CE, Fellows B. Interventional techniques in the management of chronic pain: part 1.0. Pain Physician. 2000;3:7–42. 6. Chopra P, Smith HS, Deer TR, Bowman RC. Role of adhesiolysis in the management of chronic spinal pain: a systematic review of effectiveness and complications. Pain Physician. 2005;8:87–100. 7. Trescot AM, Chopra P, Abdi S, Datta S, Schultz DM. Systematic review of effectiveness and complications of adhesiolysis in the management of chronic spinal pain: an update. Pain Physician. 2007;10:129–146. 8. Manchikanti L, Rivera JJ, Pampati V, et al. One day lumbar epidural adhesiolysis and hypertonic saline neurolysis in treatment of chronic low back pain: a randomized double blind trial. Pain Physician. 2004;7:177–186. 9. Helm Ii S, Benyamin RM, Chopra P, Deer TR, Justiz R. Percutaneous adhesiolysis in the management of chronic low back pain in post lumbar surgery syndrome and spinal stenosis: a systematic review. Pain Physician. 2012;15:E435–E462. 10. Manchikanti L, Pampati V, Bakhit CE, Pakanati RR. Non-endoscopic and endoscopic adhesiolysis in post-lumbar laminectomy syndrome: a

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Copyright © 2014 American Society of Regional Anesthesia and Pain Medicine. Unauthorized reproduction of this article is prohibited.

Clinical effectiveness of percutaneous adhesiolysis versus transforaminal epidural steroid injection in patients with postlumbar surgery syndrome.

A number of patients with postlumbar surgery syndrome (PLSS) do not experience satisfactory results after epidural injection. A main reason for failur...
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