REVIEW For reprint orders, please contact: [email protected]

A review of the role of epidural percutaneous adhesiolysis

Practice Points

Standiford Helm* „„ Percutaneous adhesiolysis offers a low-risk, minimally invasive treatment option. „„ Patients with low back and/or leg pain due to post lumbar surgery syndrome or spinal stenosis

refractory to other treatments are candidates for the procedure. „„ The procedure is most commonly performed as a 1-day outpatient procedure. „„ Percutaneous adhesiolysis is usually done in the lower lumbar region, but can also be used throughout

the lumbar, thoracic and cervical spine. „„ The use of a spring-wound, shear-resistant catheter is a necessary component of the procedure. „„ Large volumes of local anesthetic, saline and steroid are injected into the area of the filling defect. „„ Normal saline rather than hypertonic saline can be used. „„ There is no evidence showing the need for hyaluronidase, although many protocols continue to include it. „„ Reported complications have been minimal and self-limited.

SUMMARY Low back and leg pain can arise for a variety reasons, including epidural scarring caused by post lumbar surgery syndrome, infection or bleeding. Treatment options for low back and/or leg pain caused by epidural scarring include conservative approaches, such as physical therapy and medication management, and procedures, such as epidural steroid injections. Despite appropriate treatment, pain can persist in these patients. Surgery is often not an option for patients whose pain is caused by scarring. Percutaneous adhesiolysis is a minimally invasive technique, which is effective in treating refractory low back and leg pain arising from epidural scarring. It involves the use of a spring-wound, shear-resistant catheter, ideally placed in the ventrolateral aspect of the epidural space for the lysis of adhesions, allowing medications to reach the involved nerve and removing compression of the nerve. After mechanical lysis of adhesions, relatively large volumes of local anesthetic, saline, steroid and radiopaque contrast material are injected. Either hypertonic or normal saline may be used, along with hyaluronidase. After the procedure, the patient should perform exercises to stretch the nerve roots. While this has been studied as a caudal procedure, thoracic and cervical procedures have also been described, using both transforaminal and interlaminar approaches. With trained practitioners, complications are minimal. The effectiveness of the procedure has been documented by high-quality randomized controlled ­trials and observational studies for both postlumbar surgery syndrome and spinal stenosis. part of

*The Helm Center for Pain Management, Laguna Hills, CA, USA; [email protected]

10.2217/PMT.12.65 © 2012 Future Medicine Ltd

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REVIEW Helm Percutaneous adhesiolysis is a procedure designed to break up scarring in the epidural space in order to relieve chronic low back and leg pain. In patients without chronic pain, there is free flow of dye in the epidural space. Chronic pain patients, however, often have filling defects consistent with epidural scarring [1]. Epidural scarring can arise for a variety of reasons, most obviously after lumbar spine surgery or infection, but also after disc herniation, spinal stenosis with degenerative disease and associated bleeding, and pathological fractures [2]. Epidural fibrosis, while initially controversial as a cause of pain, is present after all types of lumbar surgery, including minimally invasive procedures and can cause persistent low back and leg pain [3–13]. Ross et al. found a direct relationship between the amount of scarring and the risk of radicular pain [14]. Scarring can occur after epidural infection or hematoma. Furthermore, annular tears with the leakage of nuclear material out of the disc can cause inflammation and scarring [15]. This irritation is mediated by a variety of inflammatory mediators, including TNF, interleukins, cytokines and prostaglandin E2 [16–21]. In addition, irritation of the nerve can lead to inflammatory responses [22–28]. Less obviously, spinal stenosis, with the deterioration of the discs, facet joints and ligamentum flavum, can lead to intermittent, subclinical bleeding from the rich venous plexus in the epidural space, leading over time to

Figure 1. Epidurogram showing filling defect at L5 on the left. Courtesy of Gabor B Racz.

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the presence of fibrosis. This bleeding explains the pathological finding of epidural scarring in the absence of other causative factors [29–32]. Scarring can cause pain by restricting nerve movement, by compressing nerves or by compressing veins, which become engorged, leading either to decreased nutrition to the nerve or to secondary compression of the nerve [33,34]. Fibrosis with neural compression can lead to increased neural sensitivity [35–38]. Nutrient transport to nerves can be reduced 20–30% by as little as 10 mmHg pressure [39,40]. Recent evidence suggests that scarring may also cause pain arising from the peridural membrane [41]. The highly innervated ventrolateral aspect of the epidural space appears to be the primary region from which pain originates from epidural scarring [1,42–46]. Scarring can also prevent medications used to treat the inflammation from ­reaching their target at the nerve. History Percutaneous adhesiolysis was first conceived by Gabor Racz. The initial step towards developing the procedure was Racz’s development of a springwound catheter, which could be manipulated in the epidural space without being sheared, for use with neurolytic injections [47,48]. Racz realized in the late 1980s that epidural adhesions can be a cause of persistent pain and that the adhesions could inhibit treatment with epidural steroid injections by preventing the steroids and local anesthetic from reaching their target at the nerve. The spring-wound catheter could be used to break up these adhesions, allowing the medications to reach the nerve [49]. He proposed adding hypertonic (10%) saline for its local anesthetic action and also because the injected saline will expand 11-fold as it equilibrates with the surrounding 0.9% saline, thereby creating hydrostatic pressure to help lyse the scar. Racz then added hyaluronidase for its potential ability to lyse scars and to allow the injectate to spread more widely [39]. Percutaneous adhesiolysis, as first described by Racz, was a 3-day inpatient procedure invlolving placement of the catheter into the filling defect seen during epidurography (Figure 1) with a subsequent injection of radiopaque dye after adhesiolysis to confirm good filling (Figure 2) and to ensure that there was no injection into a loculation. The potential risk of injecting into a locution is putting increased pressure on a nerve root, leading to damage to the root. Veihelmann points out the desirability of replicating the patient’s pain

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A review of the role of epidural percutaneous adhesiolysis  with a ventrolateral placement of the catheter [50]. Local anesthetic, steroid and hyaluronidase are then injected. The patient is taken to the recovery room and observed for 30 min to ensure that no subarachnoid injection has occurred. Hypertonic saline, if injected into the subarachnoid space, is neurolytic [51,52]. With the confirmation that no subarachnoid injection is present, hypertonic saline, usually 10%, is then injected. The catheter is kept in place and the procedure repeated for the next 2 days. The procedure is done under fluoroscopy, with the patient sedated, but responsive. A critical adjunct to the adhesiolysis procedure is ‘neural flossing’ exercises, such as bringing the knees to the chest, to stretch the nerve. The purpose is to combine external mechanical stretching of the nerve with mechanical and hydrostatic epidural pressures to free the nerve. Manchikanti demonstrated in 1999 that outpatient 1-day and 2-day (with the patient sent home with a catheter to return the next day) variations of the Racz procedure were equally as effective as the 3-day procedure. The 1-day procedure has subsequently been accepted as the most commonly used protocol [53,54]. In 2010, there were 14,527 1-day adhesiolysis procedures performed on Medicare patients in the USA; for the same year, there were 1,023 3-day procedures performed [Pampati V, Pers. Comm.]. Interestingly, 32% of the 3-day procedures were reported as being performed in the outpatient setting, suggesting that some practitioners are continuing to place the catheter and have the patient return to the office for repeat injections. The procedure has since been expanded from the original, and most commonly used and studied, caudal approach to include interlaminar, transforaminal, thoracic and cervical

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Figure 2. Epidurogram after adhesiolysis showing contrast spread at L5 on the left. Courtesy of Gabor B Racz.

approaches [55]. Box 1 provides a typical protocol for the 1-day procedure using hypertonic saline. Adhesiolysis, as originally described, was a mixture of a variety of methods to lyse adhesions: mechanical lysis with the spring-wound catheter, hydrostatic lysis with hypertonic saline along with local anesthetics and steroids, proteolytic lysis with hyaluronidase and further mechanical lysis with the postprocedural therapy to stretch nerve roots. In 1999, Racz et al. addressed the issue of whether either hypertonic saline or hyaluronidase improved outcomes [56]. Figure 3 shows their findings. While the procedure was effective in providing relief in patients with refractory back and leg pain who had failed epidural injections and who had been referred to

Box 1. Percutaneous epidural adhesiolysis, 1‑day technique. In the operating room ƒƒ Place needle into vertebral foramen via sacral hiatus ƒƒ Inject 3 ml of noniodinated contrast dye to obtain preprocedure epidurogram ƒƒ Introduce spring-wound catheter to target area and perform mechanical adhesiolysis ƒƒ Inject 10 ml of local anesthetic, steroid and, if desired, hyaluronidase ƒƒ Inject 2 ml of noniodinated contrast dye to obtain a postprocedure epidurogram ƒƒ Secure catheter and transport patient to the recovery area In recovery ƒƒ After waiting 30 min to ensure that there is no subarachnoid or subdural leakage, inject 6 ml of hypertonic, 10% saline in two divided doses of 3 ml each ƒƒ Remove catheter ƒƒ Provide neural flossing exercises ƒƒ Discharge patient when stable

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Visual analog scale

Subjects with reduced pain (%)

100 10% saline plus hyaluronidase 10% saline 0.9% saline 0.9% saline plus hyaluronidase

50

0 Discharge

1

3

6

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Months after treatment

Figure 3. Outcomes with and without hyaluronidase and hypertonic saline. Data taken from [46].

a tertiary treatment center, neither hyaluronidase nor hypertonic saline improved outcomes in the study. Subsequent work has suggested that hyaluronidase does contribute to the efficacy of adhesiolysis [57]. Hyaluronidase continues to be used, often with a recombinant product. An ovine-based hyaluronidase was marketed briefly for adhesiolysis but is no longer marked for that purpose. There is some suggestion that the difficulty documenting efficacy with earlier versions of hyaluronidase was related to lack of purity of earlier preparations, but that hypothesis remains unproven [58]. The issue of the importance of hypertonic saline was addressed again by Manchikanti et al. in 2004 [59]. Figure 4 shows the results of this study. Manchikanti et al. looked at patients with refractory low back pain, including failure to respond to epidurals. They compared caudal epidural steroid injections with adhesiolysis with normal (0.9%) and hypertonic (10%) saline. The end point was greater than 50% relief. Adhesiolysis with both hypertonic saline and normal saline was effective in treating patients with refractory low back and leg pain. While there was a trend for better outcomes with hypertonic saline, this difference was not statistically significant. Because of the trending to better outcomes with hypertonic saline, many

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practitioners continue to use it based upon these results [59]. Given that the major risk of the procedure came from the use of neurolytic hypertonic saline, it continues to be a matter of provider choice as to whether to use hypertonic saline or normal saline [59]. Hyaluronidase also continues to be used, both in practice and in clinical trials, at the discretion of the provider or chief investigator. These studies also raise the question of how adhesiolysis differs from an epidural steroid injection. Adhesiolysis was first defined as a 3-day procedure, clearly differentiating it from a single-shot epidural injection. Percutaneous epidural adhesiolysis has since transitioned to a 1-day procedure. Despite being a 1-day procedure, adhesiolysis is clearly distinct from a caudal, catheter-guided epidural steroid injection, both in technique and efficacy. In 1995, Devulder et al. attempted to show that improved dye flow did not improve pain [60]. This study was flawed because of a failure to use a spring-wound catheter. The critical factors defining adhesiolysis as a distinct procedure appear to be the placement of a steerable, spring-wound catheter at the ventrolateral aspect of the epidural space for the administration of local anesthetic, steroid and normal saline in the appropriate volumes, thereby lysing the adhesions. Adhesions are felt

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Patients with >50% relief (%)

A review of the role of epidural percutaneous adhesiolysis 

80 64%

72%†

72%†

72%†

60%

60%

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40 20 0%

0%

0%

0 Group I Group Group II III

Group I Group Group II III

3 months

6 months

Group I Group Group II III 12 months

Figure 4. Patients with >50% relief from caudal injections and adhesiolysis with normal or hypertonic saline. † Significant difference with Group I at the time of evaluation (p < 0.001). Data taken from [45].

to either prevent medication from reaching the inflamed nerve root or to directly or indirectly cause the nerve root to be inflamed. Replication of the patient’s usual pain is a critical factor in the success of the procedure. Evidence supporting the effectiveness of adhesiolysis Multiple studies have evaluated the effectiveness of adhesiolysis [42,53,54,56,59,61–68]. It has also been the subject of various systematic reviews and has been evaluated in treatment guidelines [1,69–75,101]. High quality observational studies and randomized controlled trials have become available since the various systematic reviews and treatment guidelines have been published. An updated systematic review of percutaneous adhesiolysis has recently been published [76]. Of the various studies evaluating percutaneous adhesiolysis, five randomized controlled trials [42,59,61,67,77] and two observational trials [66,68] are considered to be of high or moderate quality. These studies show consistent positive outcomes, including for the use of adhesiolysis for both postlumbar surgery syndrome and spinal stenosis. Patients can require up to three to four procedures per year, assuming good (greater than 50%) relief for 3 months from previous injections. Another evaluation of adhesiolysis for spinal stenosis is underway [42]. Park et al. did find that not all patients who had dye spread after the procedure had relief of pain [66].

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Several of the articles compared the efficacy of adhesiolysis to other therapies. Veihelmann et al. showed that adhesiolysis was superior to physical therapy in treating patients with chronic sciatica with or without low back pain [42]. Manchikanti found that adhesiolysis was more effective than caudal epidural steroid injection in relieving low back and lower extremity pain in patients with postlumbar surgery syndrome [67]. Thus, both from efficacy and comparative effectiveness perspectives, there is high quality evidence supporting the use of percutaneous epidural adhesiolysis to treat persistent low back and/or leg pain caused by epidural scarring, with the diagnoses of postlumbar laminectomy syndrome and spinal stenosis being most t­horoughly studied. Complications Complications associated with adhesiolysis are generally minor and transient [1,71–75,78–81]. Catheter shearing has been reported [82]. Despite being spring wound, the catheter could be sheared when the long tip of the RK needle used initially for the procedure was bent, snagging and shearing the catheter. With the current use of an Epimed Coudé® needle to enter the sacral hiatus, this complication should not occur. If a catheter cannot be easily retrieved, it should be left in place. Dural puncture can occur. No author has reported the need to treat a patient because of

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REVIEW Helm dural puncture. If dural puncture does occur, the best course is to stop the procedure, as, if hypertonic saline is injected into the epidural space, it is neurotoxic [83]. Transient, self-limited neurologic deficits have occurred [84]. As with any procedure, infection and hematoma can occur. The incidence of complications from percutaneous adhesiolysis is low and the complications are generally minimal and self-limited. The procedure should be considered to be low risk for serious adverse events when performed by well-trained physicians. Conclusion & future perspective In conclusion, adhesiolysis is a safe and effective procedure for the treatment of indications such as persistent low back and leg pain due to ­postlumbar surgery syndrome or spinal stenosis. In a world of ongoing budget constraints, there is a continued need to find faster, better and more effective means of helping our patients continue to function. Patients who are References 1

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Racz GB, Heavner JE, Trescot A. Percutaneous lysis of epidural adhesions – evidence for safety and efficacy. Pain Pract. 8(4), 277–286 (2008). Racz GB, Day MR, Heavner JE et al. Epidural lysis of adhesions and percutaneous neuroplasty. In: Pain Management. Racz G (Ed.). InTech, Shanghai, China, 337–370 (2012).

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candidates for adhesiolysis tend not to be candidates for further surgery. These patients need minimally invasive techniques to help them; adhesiolysis is such a technique. Adhesiolysis is clearly demarcated from a standard epidural injection. There is a growing body of high quality evidence supporting the efficacy of this procedure. The combination of need and efficacy should provide the basis for more w­idespread use of adhesiolysis in the future. Financial & competing interests disclosure S Helm is a clinical investigator for Epimed. He receives research support from Cephalon/Teva, AstraZeneca and Purdue Pharma. He has attended an Advisory Group Meeting for Actavis. The author has no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. No writing assistance was utilized in the production of this manuscript.

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future science group

A review of the role of epidural percutaneous adhesiolysis.

SUMMARY Low back and leg pain can arise for a variety reasons, including epidural scarring caused by post lumbar surgery syndrome, infection or bleedi...
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